Drugs.com - New Drug Approvals New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.
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FDA Approves Abrysvo (respiratory syncytial virus vaccine) for the Prevention of Respiratory Syncytial Virus (RSV) in Older Adults
on May 31, 2023 at 10:05 pm
NEW YORK--(BUSINESS WIRE) May 31, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Abrysvo™ (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F...
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FDA Approves Posluma (flotufolastat F 18) Injection, First Radiohybrid PSMA-targeted PET Imaging Agent for Prostate Cancer
on May 30, 2023 at 12:05 am
MONROE TOWNSHIP, N.J. & OXFORD, England--(BUSINESS WIRE) May 30, 2023 --Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced U.S. Food and...
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FDA Approves Inpefa (sotagliflozin) for the Treatment of Heart Failure
on May 27, 2023 at 1:05 am
THE WOODLANDS, Texas, May 26, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. Food and Drug Administration (FDA) has approved Inpefa™ (sotagliflozin), a once-daily oral tablet to reduce the...
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FDA Approves Paxlovid (nirmatrelvir tablets and ritonavir tablets) for Adult Patients at High Risk of Progression to Severe COVID-19
on May 25, 2023 at 9:05 pm
NEW YORK--(BUSINESS WIRE) May 25, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) approved Paxlovid™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19...
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FDA Approves Yuflyma (adalimumab-aaty), a Biosimilar to Humira
on May 24, 2023 at 8:05 pm
JERSEY CITY, N.J.--(BUSINESS WIRE) May 24, 2023 --Celltrion USA today announced that the U.S. Food and Drug Administration (FDA) has approved Yuflyma® (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira®...
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FDA Approves Xacduro (sulbactam and durlobactam) for the Treatment of Serious Infections Caused by Acinetobacter
on May 23, 2023 at 10:05 pm
WALTHAM, Mass.--(BUSINESS WIRE)--May 23, 2023-- Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced that the U.S. Food and Drug Administration (FDA) approved Xacduro® (sulbactam for injection;...
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FDA Approves Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
on May 23, 2023 at 9:05 pm
Plymouth Meeting, Pa. -- May 23, 2023—Braeburn announces that the U.S. Food and Drug Administration (FDA) has approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (CIII), a new weekly and monthly medication for...
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FDA Approves Opvee (nalmefene hydrochloride) Prescription Nasal Spray to Reverse Opioid Overdose
on May 22, 2023 at 9:05 pm
RICHMOND, Va., May 22, 2023 /PRNewswire/ -- Indivior PLC (LSE: INDV) today announced that the U.S. Food and Drug Administration (FDA) approved Opvee® (nalmefene) nasal spray for the emergency treatment of known or suspected opioid overdose...
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US FDA Approves the Cyltezo Pen, a New Autoinjector Option, Ahead of July 1 Commercial Launch
on May 22, 2023 at 8:05 pm
RIDGEFIELD, Conn., May 22, 2023 /PRNewswire/ -- Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the Cyltezo® Pen, a new autoinjector option for Cyltezo (adalimumab-adbm), an...
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FDA Approves Ayvakit (avapritinib) as the First and Only Treatment for Indolent Systemic Mastocytosis
on May 22, 2023 at 3:05 am
CAMBRIDGE, Mass., May 22, 2023 /PRNewswire/ -- Blueprint Medicines Corporation (Nasdaq: BPMC) today announced that the U.S. Food and Drug Administration (FDA) has approved Ayvakit® (avapritinib) for the treatment of adults with indolent systemic...
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FDA Approves Epkinly (epcoritamab-bysp) Bispecific Antibody to Treat Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
on May 19, 2023 at 11:05 pm
NORTH CHICAGO, Ill., May 19, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved Epkinly (epcoritamab-bysp), as the first and only T-cell engaging bispecific antibody for the...
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U.S. FDA Approves Rinvoq (upadacitinib) as a Once-Daily Pill for Moderately to Severely Active Crohn's Disease in Adults
on May 19, 2023 at 2:05 am
NORTH CHICAGO, Ill., May 18, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved Rinvoq® (upadacitinib) for the treatment of adults with moderately to severely...
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FDA Approves Vyjuvek (beremagene geperpavec-svdt) Redosable Gene Therapy for the Treatment of Dystrophic Epidermolysis Bullosa
on May 19, 2023 at 2:05 am
PITTSBURGH, May 19, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the Company) (NASDAQ: KRYS), a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases, today announced the US Food and...
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FDA Approves Miebo (perfluorohexyloctane) Ophthalmic Solution for the Treatment of the Signs and Symptoms of Dry Eye Disease
on May 18, 2023 at 2:05 am
VAUGHAN, Ontario & HEIDELBERG, Germany--(BUSINESS WIRE)-- May 18, 2023 -- Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, and...
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FDA Approves Skinvive by Juvéderm (hyaluronic acid) Microdroplet Injection to Improve Skin Smoothness of the Cheeks
on May 15, 2023 at 10:05 pm
IRVINE, Calif., May 15, 2023 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of Skinvive™ by Juvéderm® to improve skin smoothness of the cheeks in adults over the...
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Caldolor Now FDA Approved for Treatment of Fever & Pain in Infants
on May 15, 2023 at 1:05 am
NASHVILLE, Tenn., May 15, 2023 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved expanded labeling for Caldolor, an...
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FDA Approves Veozah (fezolinetant) for the Treatment of Vasomotor Symptoms Due to Menopause
on May 13, 2023 at 9:05 pm
TOKYO, May 13 2023 – Astellas Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Veozah (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause1...
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Otsuka and Lundbeck Announce U.S. FDA Approval of Supplemental New Drug Application (sNDA) for Rexulti (brexpiprazole) for the Treatment of Agitation Associated with Dementia Due to Alzheimer’s Disease
on May 10, 2023 at 10:05 pm
PRINCETON, NJ and DEERFIELD, IL – May 10, 2023 – Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Lundbeck LLC (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of...
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FDA Approves Elfabrio (pegunigalsidase alfa-iwxj) for the Treatment of Adult Patients with Fabry Disease
on May 10, 2023 at 10:05 pm
BOSTON and CARMIEL, Israel, May 10, 2023 /PRNewswire/ -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, and Protalix BioTherapeutics,...
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Farxiga Extended in the US to Reduce Risk of Cardiovascular Death and Hospitalisation for Heart Failure to a Broader Range of Patients
on May 9, 2023 at 11:05 pm
May 9, 2023 -- AstraZeneca’s Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death, hospitalisation for heart failure (hHF) and urgent heart failure (HF) visits in adults with HF. The approval by...
