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Results For "FDA"

1778 News Found

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
Diagnostic Center | 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


Cipla receives final approval for the generic version of Somatuline Depot Injection
Drug Approval | May 23, 2024

Cipla receives final approval for the generic version of Somatuline Depot Injection

Cipla's Lanreotide Injection is AP-rated therapeutic equivalent generic version of Somatuline Depot (Lanreotide) Injection


Glenmark receives ANDA approval for Brimonidine Tartrate and Timolol Maleate ophthalmic solution
Drug Approval | May 18, 2024

Glenmark receives ANDA approval for Brimonidine Tartrate and Timolol Maleate ophthalmic solution

According to IQVIATM sales data for the 12-month period ending March 2024, the Combigan Ophthalmic Solution, 0.2%|0.5% market achieved annual sales of approximately $290.0 million