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2190 News Found

Pfizer and BioNTech receive Positive CHMP opinion for Omicron JN.1-adapted COVID-19 vaccine in EU
News | June 28, 2024

Pfizer and BioNTech receive Positive CHMP opinion for Omicron JN.1-adapted COVID-19 vaccine in EU

Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission


Imfinzi approved in the US for endometrial cancer
Drug Approval | June 17, 2024

Imfinzi approved in the US for endometrial cancer

Approval based on DUO-E trial results, which showed Imfinzi reduced the risk of disease progression or death by 58% vs. chemotherapy


Farxiga approved in the US for the treatment of paediatric type-2 diabetes
Drug Approval | June 14, 2024

Farxiga approved in the US for the treatment of paediatric type-2 diabetes

Approval based on results from T2NOW, one of the largest paediatric type-2 diabetes Phase III trials to date


Torrent Pharmaceuticals gets Form 483 with 5 observations for Indrad facility
Drug Approval | June 13, 2024

Torrent Pharmaceuticals gets Form 483 with 5 observations for Indrad facility

There was no observation related to data integrity reported


Glenmark receives ANDA approval for Esomeprazole Magnesium Delayed-Release capsules
Drug Approval | June 12, 2024

Glenmark receives ANDA approval for Esomeprazole Magnesium Delayed-Release capsules

Glenmark's current portfolio consists of 197 products authorized for distribution in the U.S. marketplace


Abbott wins CE mark for dual-chamber leadless pacemaker
News | June 11, 2024

Abbott wins CE mark for dual-chamber leadless pacemaker

Abbott's first-of-its-kind i2i technology enables synchronized communication between two leadless pacemakers


Briefs: Dr. Reddy's Laboratories and Ami Organics
News | June 08, 2024

Briefs: Dr. Reddy's Laboratories and Ami Organics

Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility


Indoco Remedies receives tentative ANDA approval for Canagliflozin, Metformin Hydrochloride Tablets
Drug Approval | June 07, 2024

Indoco Remedies receives tentative ANDA approval for Canagliflozin, Metformin Hydrochloride Tablets

Canagliflozin and Metformin Hydrochloride Tablets are used to treat type 2 diabetes mellitus


Hyperfine bringing Swoop to India through distribution partnership with Radiosurgery Global
Medical Device | May 30, 2024

Hyperfine bringing Swoop to India through distribution partnership with Radiosurgery Global

Strategic focus on India aims to make the Swoop® portable MR brain imaging system commercially available in a vast and underserved MRI market


Novartis atrasentan Phase III data show clinically meaningful proteinuria reduction
Clinical Trials | May 27, 2024

Novartis atrasentan Phase III data show clinically meaningful proteinuria reduction

Through its rare kidney disease portfolio, Novartis is committed to exploring a range of treatment options with different modes of action to slow IgAN progression