AstraZeneca-Daiichi Sankyo application for Datopotamab deruxtecan accepted in US for patients with previously treated advanced nonsquamous non-small cell lung cancer Ruchika Sharma19 Feb 2024 4:30 PM ISTCambridge: AstraZeneca and Daiichi Sankyo's Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US...
Telangana drug regulator becomes eligible to observe USFDA inspections Ruchika Sharma18 Feb 2024 11:30 AM ISTThe DCA DG said this collaboration could potentially lead to enhanced regulatory harmonisation, improved compliance with global standards, and better...
Roche Xolair gets USFDA nod for children, adults with one or more food allergies Ruchika Sharma17 Feb 2024 4:30 PM ISTIn the U.S., Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.
Gilead Sciences pauses enrollment globally in magrolimab solid tumor studies Ruchika Sharma17 Feb 2024 2:43 PM ISTFoster City: Gilead Sciences, Inc. has announced that it has paused enrollment globally in the magrolimab solid tumor studies. The U.S. Food and Drug...
Zydus Lifesciences secures USFDA okay for angina drug Isosorbide Mononitrate ER Ruchika Sharma16 Feb 2024 3:52 PM ISTAhmedabad: Pharma major Zydus Lifesciences Limited has announced that the Company has received final approval from the United States Food...
Lupin bags USFDA nod for pregnancy prevention drug Minzoya Ruchika Sharma16 Feb 2024 3:02 PM ISTMinzoya Tablets are indicated for use by females of reproductive potential to prevent pregnancy.
Philips recall of imaging machines classified as most serious by USFDA Ruchika Sharma16 Feb 2024 1:30 PM ISTThere has been one incident related to use of the device, but no reports of injuries or deaths, the FDA said.
Lupin unveils Ganirelix Acetate Injection in US Ruchika Sharma16 Feb 2024 11:24 AM ISTIt is indicated for the inhibition of premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation.
Bristol Myers Squibb application for Augtyro for NTRK-Positive Locally Advanced or Metastatic Solid Tumors accepted by USFDA for priority review Ruchika Sharma15 Feb 2024 11:13 AM ISTPrinceton: Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug...
USFDA successfully concludes inspection at Unichem Labs Ghaziabad facility Ruchika Sharma14 Feb 2024 12:15 PM ISTMumbai: Unichem Labs has announced that the United States Food and Drug Administration (USFDA) has successfully concluded inspection without any...
Lupin unveils Bromfenac Ophthalmic Solution, 0.075% in US Ruchika Sharma14 Feb 2024 11:30 AM ISTMumbai: Global pharma major Lupin Limited has announced the launch of Bromfenac Ophthalmic Solution, 0.075%, after having received an approval...
Dr Reddy's Labs gets USFDA VAI classification for Hyderabad RnD centre Ruchika Sharma13 Feb 2024 3:00 PM ISTHyderabad: Dr Reddy's Laboratories has said the US health regulator has granted Voluntary Action Indicated (VAI) classification to its...
