USFDA declines to approve Viatris-Mapi Pharma's monthly multiple sclerosis injection Ruchika Sharma12 March 2024 11:56 AM ISTThe companies were seeking the FDA's nod for GA Depot, a long-acting version of glatiramer acetate, which is approved for relapsing forms of MS.
Zydus Lifesciences gets USFDA EIR for API Ahmedabad facility Ruchika Sharma11 March 2024 11:45 AM ISTAhmedabad: Zydus Lifesciences has announced that the Company has received the EIR report from the United States Food and Drug Administration...
FDA approves semaglutide for major heart disease prevention among obese Dr. Kamal Kant Kohli10 March 2024 9:15 PM ISTThe US Food and Drug Administration (FDA) has approved semaglutide (Wegovy) for reducing risk of cardiovascular death, heart attack, and stroke in...
USFDA delays decision on Eli Lilly Alzheimer's drug Donanemab Ruchika Sharma10 March 2024 4:30 PM ISTWhite said the FDA wants the expert panel to discuss some of the unique aspects of the clinical trial used in its request for a traditional FDA...
Novo Nordisk Wegovy gets USFDA nod for lowering heart risks Ruchika Sharma9 March 2024 2:30 PM ISTDenmark: Novo Nordisk has announced that the US Food and Drug Administration (FDA) has approved a label expansion for Wegovy based on a...
USFDA approves Opdivo in combo with Cisplatin and Gemcitabine for first-line treatment of adult patients with metastatic Urothelial Carcinoma: Bristol Myers Squibb Ruchika Sharma9 March 2024 1:30 PM ISTPrinceton: Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab), in combination...
Alembic Pharma gets 4 USFDA observations for Panelav facility Ruchika Sharma9 March 2024 12:30 PM ISTVadodara: Alembic Pharma has announced that the Company has received a Form 483 with four procedural observations from the United States...
Sun Pharma unit recalls over 54000 bottles of Mesalamine ER capsules in US Ruchika Sharma9 March 2024 11:24 AM ISTThe affected lot of capsules have been manufactured by Sun Pharmaceutical Industries at its Mohali-based manufacturing plant and distributed in the US...
FDA Clears First Over-the-Counter Continuous Glucose Monitor Dr. Kamal Kant Kohli8 March 2024 6:00 AM ISTToday, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo...
USFDA gives nod for commercial production at Zydus Ahmedabad API unit Ruchika Sharma7 March 2024 5:07 PM ISTAhmedabad: Pharma major Zydus Lifesciences has announced that the company has received Post Application Action Letter from the US Food and...
Boehringer Ingelheim accused of misusing US patents to delay asthma-drug rivals Ruchika Sharma7 March 2024 12:38 PM ISTGerman drugmaker Boehringer Ingelheim was accused in a federal lawsuit in Boston on Wednesday of improperly submitting patents to the U.S. Food and...
FDA approves new dermal filler for hollows in upper face Dr. Kamal Kant Kohli6 March 2024 6:00 PM ISTThe US Food and Drug Administration (FDA) has approved hyaluronic acid dermal filler, Juvederm Voluma XC for use in upper face for first time. The...
