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

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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)

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-

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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

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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

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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)

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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

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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

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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

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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

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FDA Approves Uzedy (risperidone) Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults

PARSIPPANY, N.J., TEL AVIV & PARIS, April 28, 2023 -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext: MEDCL) announced

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FDA Approves Abilify Asimtufii (aripiprazole) for the Treatment of Schizophrenia or Maintenance Monotherapy Treatment of Bipolar I Disorder in Adults

April 28, 2023 -- Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA)

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FDA Approves Vowst (fecal microbiota spores, live-brpk) for Prevention of Recurrence of C. difficile Infection in Adults Following Antibacterial Treatment for Recurrent CDI

CAMBRIDGE, Mass. & HOBOKEN, N.J.--(BUSINESS WIRE)--Apr. 26, 2023 -- Seres Therapeutics, Inc. (Nasdaq: MCRB) and Nestlé Health Science today announced the U.S. Food and Drug Administration (FDA) ap

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