FDA Approves Posluma (flotufolastat F 18) Injection, First Radiohybrid PSMA-targeted PET Imaging Agent for Prostate Cancer
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 ra
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
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