FDA Approves Suflave (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride) Colonoscopy Preparation that Tastes Similar to a Sports Drink

BRAINTREE, Mass., June 22, 2023 /PRNewswire/ -- Sebela Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) granted approval of Suflave™ (polyethylene glycol, sodium sulfat

Latest News NDA News 1147
Read All

FDA Approves Abrysvo (respiratory syncytial virus vaccine) for the Prevention of Respiratory Syncytial Virus (RSV) in Older Adults

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 comp

Latest News NDA News 1100
Read All

FDA Approves Inpefa (sotagliflozin) for the Treatment of Heart Failure

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

Latest News NDA News 814
Read All

FDA Approves Paxlovid (nirmatrelvir tablets and ritonavir tablets) for Adult Patients at High Risk of Progression to Severe COVID-19

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 t

Latest News NDA News 927
Read All

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

Latest News NDA News 1033
Read All

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)

Latest News NDA News 969
Read All

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

Latest News NDA News 1125
Read All

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

Latest News NDA News 1124
Read All

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

Latest News NDA News 1204
Read All

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-

Latest News NDA News 1075
Read All

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

Latest News NDA News 963
Read All

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

Latest News NDA News 1297
Read All
News
- CLINIEXPERT -
Int'l Clinical Service Expert

We are the leader
Because of our professionism