The FDA urges. It consists of a combination of six hyaluronic acids and is indicated to boost the appearance of the lips and cheekbones. r/cosplayers. The key is to use products and techniques that minimize irritation. (OCUP) Ocuphire Pharma's Nyxol Eye Drops, proposed. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal. hana-maru. cities — including one in Western North Carolina — have been approved by the FDA to expand patient access to MDMA. In patients with acute STEMI undergoing primary PCI, biodegradable polymer sirolimus-eluting stents were superior to durable polymer everolimus-eluting stents with respect to target lesion failure at 1 year. Get Directions. Percutaneous coronary intervention (PCI) technology has advanced since the first human coronary balloon angioplasty in 1977, with coronary stents (including drug-eluting stents [DES]) ensuring better safety and efficacy after PCI1. If you are considering a regenerative medicine product and have questions about how it is regulated (including whether FDA approval is required), whether it is FDA-approved, or. Suitable for all skin-types, this powerful treatment can be used weekly or for special occasions to boost any anti-aging routine. ) EUA differs from the FDA’s “fast track” designation. Animal & Veterinary. FDA Approves Truqap (capivasertib) plus Faslodex for Patients with Advanced HR-Positive Breast Cancer - November 17, 2023. Veteran Jonathan Lubecky acquired PTSD during his tour of Iraq in 2005 to 2006. Last year the FDA’s Center for Drug Evaluation and Research (CDER) approved 37 novel drugs. Food and Drug Administration 10903 New Hampshire Ave WO71-3103 Silver Spring, MD 20993-0002 . Rolvedon. The basis for FDA approval also included an open label study in 27 patients and a small, double-blind, placebo-controlled trial including twelve patients with blepharospasm . Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. Date of Approval: November 16, 2023. PMA Approvals: Listings of all new or high-risk medical devices that were approved via the premarket approval (PMA) pathway. This Fact Sheet informs you of the significant known and potential. probes. 4 FDA Draft Guidance for Industry and FDA Staff. Today, the U. Domestic and foreign establishments that manufacture, repack, or re-label drug and biologic products, including vaccines, are required to. Kerendia. There is no adequate, approved, and available alternative to the emergency use of your September 11, 2023 Today, the U. A conditionally approved product has met all the requirements to support the full approval of the new animal drug except for a. It was made of stainless steel (strut thickness 140 µm), but the polystyrene-block-isobutylene-block-styrene polymer eluted paclitaxel, a cytostatic antineoplastic drug. S. Elon Musk's Neuralink received U. Food and Drug Administration approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often. 3. Consumer: 888-INFO-FDA. Use once a week. The FDA approved two ADCs in 2021. Idaho Technology, Inc. Safety and. Quick look. Today, the U. Medium Risk. On March 4, 2022, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) with platinum-doublet chemotherapy for adult patients with resectable non-small cell. While first-generation DES typically used durable polymers to store and modulate the release of the anti-proliferative drug, later generations have introduced biodegradable polymers with. requests, the letter was revised and reissued by FDA on August 10, 2021,5 November 8, 2021,6 and April 4, 2022. Resolute Onyx stents (BIONYX): rationale and design of the randomized TWENTE IV multicenter trial. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the. We would like to show you a description here but the site won’t allow us. On September 23, 2021, the FDA revised the EUAs of certain molecular, antigen, and serology tests to establish additional Conditions of Authorization in. The BIONYX trial was equally funded by Biotronik, and Medtronic. S. Carefully press down on the tip of the syringe. , high blood pressure, high cholesterol, Type 2 diabetes). It is manufactured by Labo Cosprophar Suisse [1], a Swiss company dedicated to. Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting. The US Food and Drug Administration approved the medication Zepbound last week to treat chronic obesity. The U. Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U. FDA approved the first COVID-19 vaccine, which has been known as the Pfizer-BioNTech COVID-19 Vaccine, and is now marketed. S. decisions pave the way for Gilead's drug into two major markets, both with soaring COVID-19 cases. Approval: 1963 -----INDICATIONS AND USAGE----- METROGEL, 1% is a nitroimidazole indicated for the topical treatment. To find out if a drug is approved by FDA, consumers can use two different Internet sites: Drugs@FDA lists most prescription and over-the-counter (OTC) drug products approved since 1939. Donated photo. 12/14/2022. The Food and Drug Administration approved a new round of vaccines against COVID-19. Category. The drug, while FDA-approved, may not be easier to access. S. 3. Primary study endpoint results demonstrated that. Unauthorized products may be used, expired or counterfeit and present a serious health risk. Patients with rare diseases often have few or no. This difference was driven by reduced ischaemia-driven target lesion revascularisation in patients treated with biodegradable polymer. Approved for: Head and neck squamous cell cancer. . 2. It is estimated that 1 in 5 outpatient prescriptions are written off-label. In 2011, FDA approved Makena to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. Today, the U. One year later, tofacitinib was also approved for the treatment of rheumatoid arthritis . Objectives: The aim of this study was to assess 2-year safety and efficacy of the current-generation thin composite-wire-strut durable-polymer Resolute Onyx zotarolimus-eluting stent (ZES), compared with the ultrathin-strut biodegradable-polymer Orsiro sirolimus-eluting stent (SES) in all-comers and a pre-specified small-vessel subgroup analysis. Second, the FDA needs more detailed chemistry, manufacturing, and control data (including requiring facility inspections) in a BLA. The FDA approval of Crysvita for TIO was based on data from two single-arm Phase 2 studies, a 144-week study in 14 adult patients conducted by Ultragenyx in the United States and an 88-week study. On October 16, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent. Initial U. Administer 1,500+ wrinkle relaxers annually on average. 8 min. The FDA regulates approval of medications, not prescribing of medications. S. A. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently. Fresh 1. Potential 7 years of market exclusivity after approval; In addition, the Orphan Drug Act established the Orphan Product Grants Program to provide funding for developing products for rare diseases. Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations. 16. Bionyx is a luxury purveyor of colloidal platinum-infused face and body products. In a news release on Aug. October 31, 2023. Non-clinical engineering tests and recommended labeling for intravascular stents and associated delivery systems. Food and Drug Administration today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with. Strong public demand that government “do something” about periodic drug disasters has played a central role in developing the FDA. Like Novo Nordisk’s Ozempic and Wegovy, Zepbound belongs to a class of medications called GLP-1 agonists. Credit: Getty Images. Household/Urban Pesticides. Drug Name Active Ingredient Approval Date FDA-approved use on approval date* 51. While first-generation DES typically used durable polymers to store and modulate the release of the anti-proliferative drug, later generations have introduced biodegradable polymers with. BioNTech Manufacturing GmbHIntroduction. 3. Today, the U. S. By carefully selecting our ingredients and developing formulations that are highly effective without compromising luxury, Bionyx ensures that each. Size: 12g / 0. An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current. The Platinum Transformative Thermal Mask. Safety, metabolism and excretion of the drug are also emphasized. On April 1, 2022, the Food and Drug Administration approved axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc. 7 are drugs for treating autoimmune diseases. The U. The B4000 Bed System Measurement Device provides clear pass/fail indicators when assessing the four critical entrapment zones of a hospital bed system. Media: FDA Office of Media Affairs. On Wednesday, President Joe Biden told CNN’s Don Lemon during a CNN Townhall that he expects Covid-19 vaccines could get full approval “quickly. 20. S. S. Target validation, compound screening, and lead optimization are the first three in silico and in. Food and Drug Administration issued a new emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test which is authorized for use by. Division of Communication and Consumer Affairs Office of Communication, Outreach and Development Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave. Thanks to its partners in research, medicine, its bioproduct suppliers and its shareholders, the company innovates on a daily. (877) 532-1957. regulators. Today, the U. 8, 2023 Updated Nov. Español. Cosmetic products and. ) for adult patients with large B-cell lymphoma (LBCL) that is refractory to first. Continue reading "Bionyx Skin Care Review" The study design and details of the BIO-RESORT (Comparison of biodegradable polymer and durable polymer drug-eluting stents in an all-comers population; NCT01674803) and BIONYX (Bioresorbable polymer-coated Orsiro versus durable polymer-coated Resolute ONYX stents; NCT025087140) trials have been reported previously [6, 7]. Español. Gendicine is the first gene therapy product approved for clinical use in humans. BioLineRx gains after winning first FDA approval. and monitors the safety of all regulated medical products. This approval was based on a. Español. ) for adult patients with unresectable or metastatic HER2-low (IHC 1+ or. Clinics in 10 U. Tobacco Products. FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. Bionyx is a luxury purveyor of colloidal platinum-infused face and body products. B4000 Bed System Measurement Device. Food and Drug Administration approved Mounjaro (tirzepatide) injection to improve blood sugar control in adults with type 2 diabetes, as an addition to diet and. Comirnaty is a mRNA vaccine. all bionyx retail locations are independently owned and managed *Manufacturer Warning: BIONYX strongly advises against the purchase of any BIONYX product from unauthorized online vendors. Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332)An FDA-approved biosimilar is a biological product that is highly similar to and has no clinically meaningful differences in terms of safety, purity and potency (safety and effectiveness) from an. Furthermore, patient management strategies for acute coronary syndrome (ACS). eflapegrastim. Of note, the last fusion protein approved by the FDA was in 2018, with tagraxofusp, indicated for the treatment of blastic plasmocytoid dendritic cell neoplasm . $ 350. today announced that the companies have entered into a definitive. The Food and Drug Administration on Wednesday approved Eli Lilly’s diabetes drug for treating obesity, opening the door for widespread insurance coverage that could make the sought-after. To reduce the risk of kidney and. A: Investigational New Drug (IND) -- Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Moderna said the FDA based its decision to give full approval on scientific evidence shared by Moderna in its submission package to the agency, which included six month follow up data from a Phase. FDA regulates the sale of medical device products in the U. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Our STN: BL 125742/0 . Apply a small amount to cotton pad, and gently smooth over freshly cleansed skin. Device Name. The Wingspan Stent System is Food and Drug Administration (FDA) approved with human device exemption for a limited patient group and despite numerous prospective registries and trials. S. Ocuphire Pharma Inc. Rebyota is approved for the prevention of recurrence of. New Applications. Treatment for: Breast Cancer. The trials were conducted. Microneedling devices are not approved for delivery of cosmetics, topical medications (for example, creams, ointments, gels), vitamin solutions, drugs, or blood products (for example, platelet. Natural Wrinkle Fillers and Creams. The annual biological approvals are broken into lists based on these regulatory authorities. Credit: Getty Images. Eleonora Lad, MD, PhD, director of clinical research and associate professor, was a lead investigator in the OAKS trial, a pivotal clinical trial. 9/9/2022. 00. In June, blinatumomab (Blincyto) received full approval to treat adult and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) who are in first or second complete. However, in 2019, three JAK inhibitors were approved for clinical use [66,67,68]. Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease. A month’s supply costs about $1,000 a month out of pocket. The Food and Drug Administration on Monday approved Biogen ’s Alzheimer’s disease drug aducanumab, making it the first medication cleared by U. November 2017. It can be used by adults with a body mass index (BMI) greater than or equal to 30 mg/kg² alone or 27 mg/kg² with at least one weight-related condition (e. CBER has approved both cellular and gene therapy products. We can get you your eye drops in as little as 48 hours from your blood draw. 68, down 4%. Consumer: 888-INFO-FDA. Finally, the BIONYX trial,. At the end of March the U. Below is a. S. Buy Bionyx Transformative Fine Line Syringe New Advanced Edition 12g on Amazon. ”. For Immediate Release: May 25, 2023. We would like to show you a description here but the site won’t allow us. 4 FDA Draft Guidance for Industry and FDA Staff. For both trials. On August 10, 2022, the Food and Drug Administration granted regular approval to capmatinib (Tabrecta, Novartis Pharmaceuticals Corp. 7. WATCH VIDEOS. Transform your skin with Bionyx platinum skincare. This has allowed us to create product lines that target the most common skin issues while preventing future signs of aging. June 13, 2022. 5 million people in the U. Based on this analysis, Resolute Onyx™ was the first DES FDA-indicated for HBR patients and labeled for 1-month DAPT. It contains a piece of the SARS-CoV-2 virus’s genetic material that instructs cells in the body to make the virus’s distinctive “spike” protein. 23, for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. OTC. The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses. We strive to encourage a lifestyle that promotes self-care and wellbeing. Consumer: 888-INFO-FDA. S. Today, the U. On March 18, 2022, the Food and Drug Administration approved nivolumab and relatlimab-rmbw (Opdualag, Bristol-Myers Squibb Company) for adult and pediatric patients 12 years of age or older with. If no mutation is detected in a plasma specimen. This difference was driven by reduced ischaemia-driven target lesion revascularisation in patients treated with biodegradable polymer. On January 25, 2022, the Food and Drug Administration approved tebentafusp-tebn (Kimmtrak, Immunocore Limited), a bispecific gp100 peptide-HLA-directed CD3 T cell engager, for HLA-A*02:01-positive. This is a. Today, the U. Food and Drug Administration approved Vowst, the first fecal microbiota product that is taken orally. Treatment for: Breast Cancer. Español. The US Food and Drug Administration (FDA) approved drugs in April and May 2023 relevant to conditions often treated by nurse practitioners and PAs. Animal Drugs @ FDA is an online database of FDA-approved animal drugs. Inclusive of wrinkle analysis, consult, and treatment. Food and Drug Administration has approved drug. June 30, 2021. Today, the U. September 20, 2019. FDA Office of Media Affairs. cities — including one in Western North Carolina — have been approved by the FDA to expand patient access to MDMA. Human drugs and therapeutic biologicals (proteins and other products derived from living sources used for therapeutic purposes) Drug Approval Reports by Month. On November 10, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and. S. On July 16, 2021, the Food and Drug Administration approved belumosudil (Rezurock, Kadmon Pharmaceuticals, LLC), a kinase inhibitor. Today, the U. The Taxus™ DES (Boston Scientific, Marlborough, MA, USA) received the CE mark in 2003 and then was FDA-approved in 2004. to win the coveted designation and giving even more. A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research,. Food and Drug Administration issued a new emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test which is authorized for use by patients at home. December 23, 2022 receive and should carefully review the BinaxNOW COVID-19 Antigen Test Instructions before they use the test. Molnupiravir is a medication that works by introducing errors into the SARS-CoV-2 virus’ genetic code, which prevents the virus. Agilent Resolution ctDx FIRST. Small vessel coronary artery disease (CAD) is present in 30% to 67% of patients undergoing percutaneous coronary intervention according to different series, representing an unmet clinical need in light of an increased risk of technical failure, restenosis, and need for repeated revascularization. JBAIDS Plague Detection Kit. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines. Veterinary Drugs. ocod@fda. Bionix® New Brand Video. g. 5 Jorge C, Dubois C. Learn More. Reinforced safety and efficacy results from the Onyx ONE Global Trial. 00. Explore best sellers, collections, and gift sets. It’s the first dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) agonist on the market. On August 19, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Co. NOTE: Certificates of Product Notification (CPNs) issued under FDA Circular No. finerenone. Israel-based biotech BioLineRx Ltd. ) EUA differs from the FDA’s “fast track” designation. In my quest to find the best skin care products out there, I recently discovered Bionyx skin care. Drug Products. FlexAbility Ablation Catheter, Sensor Enabled - P110016/S080. Food Products. Approvals include. Facts and news you can trust from the FDA about COVID-19 tests, treatments, and vaccines. Transdermal products are most frequently developed as transdermal delivery systems (TDS), also known as patches. 3. Truqap (capivasertib) is an AKT inhibitor used in combination with fulvestrant for the treatment of advanced HR-positive breast cancer. 2021-004 for rubbing alcohol products with concentrations of 70% and beyond will automatically be considered invalid beyond 31 December 2022. Moderna said the FDA based its decision to give full approval on scientific evidence shared by Moderna in its submission package to the agency, which included six month follow up data from a Phase. For example, OTC drug products previously available only by prescription are first approved through the NDA process and their "switch" to OTC status is approved via the NDA process. Today, the U. It is believed that BCG is taken up by urothelial and tumor. Initial U. Animal and Veterinary. Avive Automated External Defibrillator (AED) System: 10/31/2022: P210015The approval comes after an FDA committee of outside experts voted unanimously that Leqembi’s pivotal trial results verify the med’s clinical benefit, with panel members describing the trial. See the Development and Approval Process page for a description of what types of products are. This is a list of nucleic acid-based tests that have been cleared or approved by the Center for Devices and Radiological Health. These symptoms have been reported hours to. Opzelura (ruxolitinib) cream was first approved in 2021 for atopic dermatitis. Prospective, multicentre, single-arm analysis that evaluated Resolute Onyx™ DES in ~1,500 HBR patients on 1-month DAPT. Updated 12:47 PM PST, November 8, 2023. On June 22, 2022, the Food and Drug Administration granted accelerated approval to dabrafenib (Tafinlar, Novartis) in combination with trametinib (Mekinist, Novartis) for the treatment of adult. More information about the Pfizer-BioNTech COVID-19 Vaccine. U. In May 2022, the FDA approved Mounjaro (tirzepatide), a once-weekly injection for adults with Type 2 diabetes. Arexvy is approved for the. There are vibrant ones and look more natural than cosplay ones. For Immediate Release: May 10, 2022. Catheter. Catheter Tip, No Needle, FDA Approved, Without Needle, Individually Blister Packed, Medicine. JERUSALEM, Israel, November 20, 2023 -- Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment. Vital Tears has become the leader in autologous serum eye drops (ASEDs), more commonly known as serum tears, because we offer a quick, hassle-free, and affordable way to obtain serum tears. The Food and Drug Administration's regulatory approaches to marketing approval of the products it regulates are as varied as the products themselves. The drug approval process takes place within a structured framework that includes: Analysis of the target condition and available treatments —FDA reviewers analyze the condition or illness for. S. Animal and Veterinary. Transform your skin with Bionyx platinum skincare. BIONYX 82 2018 Non-inferiority . Visit Website. FDA Statement. Español. Bionix is a medical device company committed to the originality and quality in the products we bring to market. If the FDA gives the green light, the investigational drug will enter several phases of clinical trials and post-marketing approval: Phase 1: Phase 1 focuses on safety. The Food and Drug Administration on Wednesday approved an obesity drug from the company Eli Lilly that will be a direct. The updated vaccine. Bionyx, platinum skincare, is the premier choice for preventive and anti-aging skin care. Standard for Approval Under 351(a) •Standard = safe, pure, and potent _ •PHSA 351(j): –The Federal Food, Drug, and Cosmetic Act (FDCA) ^applies to a biological product subject to regulation under this section, except that a product for which a license has been approved under subsection (a) shall not be required to have an approved applicationThe FDA approval of IZERVAY is great news for the retina community and our patients suffering from GA. We strive to encourage a lifestyle that promotes self care and wellbeing through routine maintenance and a splash of indulgence. 29. Implantable Pulse Generator. December 23, 2022 receive and should carefully review the BinaxNOW COVID-19 Antigen Test Instructions before they use the test. These devices require a more rigorous premarket review than the 510 (k. 2022 FDA Approvals by Drug Class. Rinvoq is the first approved oral product available to treat moderately to severely active Crohn’s disease. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. T he federal watchdog at the Department of Health and Human Services will review the process used by. I. Keep reading below to learn why. If no mutation is detected in a plasma specimen. Rub in circular motion all over face and rinse off with cool water. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell. S. compared to FDA approved Drug Eluting Stents. The FDA, an agency within the U. Date. These. Food and Drug Administration granted marketing authorization to LetsGetChecked for the Simple 2 Test. O. Today, the U. Bionyx combines scientifically researched ingredients with new and innovative trends to bring you luxury skincare collections that enhance, refine, and define the appearance of the complexion. Average of 14 Customer Reviews. Bionyx Rhodium Facial Peeling Complex - the ultimate cleansing solution to remove impurities and exfoliate skin. 301-796-4540. Best Cooling: Origins No Puffery Cooling Roll-On at Origins. Separately for the BIO-RESORT and BIONYX trials, we assessed the 2-year clinical outcomes of diabetic patients, treated with various contemporary drug-eluting stents (DES). On March 22, 2023, the FDA granted accelerated approval to retifanlimab-dlwr (brand name Zynyz) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma. The bionyx line is based on metal and platinums, thus the name. Food and Drug Administration issued an emergency use authorization (EUA) for the BinaxNOW COVID-19 Self-Test. ), a RAS GTPase family inhibitor, for adult patients with. 21. “Today’s approval marks the first oral drug in this. No upsells, extra charges, or hidden fees. The injectable drug, made by the pharmaceutical company Eli Lilly, has the active. Medical Devices Cleared or Approved by FDA in 2020. All. Clinical utility of platinum chromium bare-metal stents in coronary heart disease. On April 3, 2020, the Food and Drug Administration approved luspatercept-aamt (REBLOZYL, Celgene Corporation) for the treatment of anemia failing an erythropoiesis stimulating agent and requiring. The FDA does not approve cosmetics. The FDA approved 37 novel drugs in 2022, the fewest to pass regulatory scrutiny since 2016. We strive to encourage a lifestyle that promotes self care and wellbeing. All 3 FDA-approved areas: forehead, between the eyebrows, and crow’s feet. FDA also approved the FoundationOne CDx (tissue) and FoundationOne Liquid CDx (plasma) as companion diagnostics for encorafenib with binimetinib. The US Food and Drug Administration (FDA) approved drugs in April and May 2023 relevant to conditions often treated by nurse practitioners and PAs.