NDA News-CliniExpert

FDA Approves Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

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)

FDA Approves Xacduro (sulbactam and durlobactam) for the Treatment of Serious Infections Caused by Acinetobacter

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) approv

FDA Approves Yuflyma (adalimumab-aaty), a Biosimilar to Humira

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/m

FDA Approves Opvee (nalmefene hydrochloride) Prescription Nasal Spray to Reverse Opioid Overdose

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 treatmen

FDA Approves Epkinly (epcoritamab-bysp) Bispecific Antibody to Treat Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

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-

FDA Approves Vyjuvek (beremagene geperpavec-svdt) Redosable Gene Therapy for the Treatment of Dystrophic Epidermolysis Bullosa

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 r

FDA Approves Miebo (perfluorohexyloctane) Ophthalmic Solution for the Treatment of the Signs and Symptoms of Dry Eye Disease

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 peo

FDA Approves Veozah (fezolinetant) for the Treatment of Vasomotor Symptoms Due to Menopause

TOKYO, May 13 2023 -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has approved Veozah (fezolinetant)

FDA Approves Elfabrio (pegunigalsidase alfa-iwxj) for the Treatment of Fabry Disease

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

FDA Approves Mydcombi (tropicamide and phenylephrine hydrochloride) Ophthalmic Spray for Inducing Mydriasis

NEW YORK, May 08, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company developing the Optejet® device for use both in connection with its own drug-device therapeuti

FDA Approves Arexvy (respiratory syncytial virus vaccine, adjuvanted) Respiratory Syncytial Virus (RSV) Vaccine for Older Adults

May 3, 2023 -- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower

FDA Approves Lumryz (sodium oxybate) for Cataplexy or Excessive Daytime Sleepiness in Adults with Narcolepsy

DUBLIN, May 01, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that the U.S. Food