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Results For "FDA"

2194 News Found

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


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


Moderna update on investigational RSV vaccine
Drug Approval | May 14, 2024

Moderna update on investigational RSV vaccine

U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024


Briefs: Lupin and Aurobindo Pharma
News | May 13, 2024

Briefs: Lupin and Aurobindo Pharma

Lupin updates on shipment of Mirabegron ER Tablets


OMRON Healthcare India and AliveCor partner to improve heart healthcare in India
Healthcare | May 11, 2024

OMRON Healthcare India and AliveCor partner to improve heart healthcare in India

These devices instantly detect various arrhythmias, including atrial fibrillation (Afib), bradycardia, tachycardia, and more


Gland Pharma receives approval for Edaravone Injection
Drug Approval | May 09, 2024

Gland Pharma receives approval for Edaravone Injection

The product is used to treat amyotrophic lateral sclerosis