JB Chemicals and Pharma Gujarat facility concludes USFDA inspection with zero observations Ruchika Sharma12 Jun 2023 2:51 PM ISTGujarat: Pharma major, J.B. Chemicals & Pharmaceuticals Limited, has recently announced that the US Food and Drug Administration (USFDA) has...
Bristol Myers Squibb gets USFDA nod for commercial production at newest Devens cell therapy manufacturing facility Ruchika Sharma11 Jun 2023 11:45 AM ISTPrinceton:: Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has approved commercial production at the...
Zydus gets USFDA nod for bowel disease drug Balsalazide Disodium Ruchika Sharma10 Jun 2023 3:17 PM ISTThe product will be manufactured at the group’s formulation manufacturing facility in SEZ, Ahmedabad, India.
USFDA advisory committee votes unanimously to confirm clinical benefit of Leqembi for Alzheimer's Disease Ruchika Sharma10 Jun 2023 1:30 PM ISTTokyo: Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System...
AstraZeneca-Sanofi Nirsevimab unanimously recommended by USFDA Advisory Committee for prevention of RSV in infants Ruchika Sharma9 Jun 2023 1:30 PM ISTLondon: The US Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) has voted unanimously 21 to 0 that AstraZeneca and...
Zydus Lifesciences secures USFDA okay for Esomeprazole Magnesium for Delayed-Release Oral Suspension Ruchika Sharma8 Jun 2023 2:51 PM ISTEsomeprazole belongs to a class of drugs known as proton pump inhibitors.
Janssen seeks USFDA nod for Carvykti for relapsed or refractory multiple myeloma Ruchika Sharma8 Jun 2023 12:30 PM ISTRaritan: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental Biologics License...
Zydus Lifesciences bags USFDA nod for pulmonary arterial hypertension drug Tadalafil Ruchika Sharma8 Jun 2023 11:32 AM ISTThe product will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, India.
Merck PREVYMIS bags USFDA nod for cytomegalovirus disease prevention in high-risk adult kidney transplant recipients Ruchika Sharma7 Jun 2023 12:39 PM ISTRahway: Merck, known as MSD outside of the United States and Canada, has announced the U.S. Food and Drug Administration (FDA) has approved a new...
GSK supplemental application for Jemperli plus chemotherapy accepted by USFDA for endometrial cancer Ruchika Sharma6 Jun 2023 3:28 PM ISTJemperli is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands...
Indoco Remedies AnaCipher CRO gets clearance on Remote Record Assessment from USFDA Ruchika Sharma5 Jun 2023 3:00 PM ISTMumbai: Indoco Remedies has announced that the company's Clinical Research Organisation (CRO), AnaCipher, located in Hyderabad has received...
Indoco Remedies gets OAI status from USFDA for Goa facility Ruchika Sharma5 Jun 2023 12:30 PM ISTMumbai: Indoco Remedies has announced that the United States Food and Drug Administration (USFDA) has determined the inspection classification of...
