Novartis expands production of Pluvicto with addition of its largest, most advanced radioligand therapy manufacturing facility in Indianapolis Ruchika Sharma7 Jan 2024 2:30 PM ISTBasel: Novartis has announced that it has received approval from the US Food and Drug Administration (FDA) for commercial manufacturing of...
Lupin bags tentative USFDA nod for Dapagliflozin and Saxagliptin Tablets Ruchika Sharma5 Jan 2024 11:11 AM ISTDapagliflozin and Saxagliptin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes...
USFDA approvals bounce back in 2023, sparking hopes of biotech recovery Ruchika Sharma3 Jan 2024 3:22 PM ISTThe U.S. Food and Drug Administration approved nearly 50% more novel drugs in 2023 than in 2022, putting it back on pace with historical levels, an...
US FDA turns down full approval of Amgen lung cancer drug Lumakras Ruchika Sharma29 Dec 2023 4:30 PM ISTNew Delhi: The U.S. health regulator on Tuesday declined to grant traditional approval to Amgen's Lumakras for treating lung cancer patients with...
Lupin bags USFDA nod for Loteprednol Etabonate Ophthalmic Suspension Ruchika Sharma28 Dec 2023 11:26 AM ISTLoteprednol Etabonate Ophthalmic Suspension, 0.2%, is indicated for the temporary relief of the signs and symptoms of seasonal allergic...
Aurobindo Pharma arm bags USFDA nod for Posaconazole Injection Ruchika Sharma27 Dec 2023 2:48 PM ISTHyderabad: Aurobindo Pharma Limited has announced that its wholly-owned subsidiary company, Eugia Pharma Specialities Limited, has received...
USFDA approves label update for Kite's Yescarta CAR T-Cell Therapy to include overall survival data Ruchika Sharma26 Dec 2023 12:00 PM ISTSanta Monica: Kite, a Gilead Company has announced that the U.S. Food and Drug Administration (FDA), has approved a label update for Yescarta...
Aurobindo Pharma arm New Jersey facility gets 10 USFDA observations Ruchika Sharma25 Dec 2023 12:22 PM ISTHyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has closed a Pre-Approval...
JnJ seeks USFDA nod for Rybrevant plus Lazertinib for EGFR-Mutated Non-Small Cell Lung Cancer Ruchika Sharma24 Dec 2023 12:30 PM ISTRaritan: Johnson & Johnson has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug...
USFDA issues 6 observations for Zydus Lifesciences Ahmedabad facility Ruchika Sharma23 Dec 2023 11:30 AM ISTAhmedabad: Zydus Lifesciences has announced that the U.S. Food and Drug Administration (USFDA) has closed the inspection with 6...
USFDA grants priority review to Merck investigational 21-valent Pneumococcal Conjugate Vaccine specifically designed to protect adults Ruchika Sharma21 Dec 2023 3:47 PM ISTRahway: Merck, known as MSD outside of the United States and Canada, has announced the U.S. Food and Drug Administration (FDA) has accepted for...
Recall of Philips medical imaging devices classified as most serious by USFDA Ruchika Sharma21 Dec 2023 12:30 PM ISTThe use of an affected system may cause serious adverse health consequences, including chemical exposure, lack of oxygen and tissue damage, according...
