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1152 News Found

Alembic announces USFDA final approval for Icatibant injection
Drug Approval | June 17, 2024

Alembic announces USFDA final approval for Icatibant injection

This is the first peptide product approval from the USFDA received by Alembic Pharmaceuticals


Zydus receives USFDA’s tentative approval for Azilsartan Medoxomil and Chlorthalidone Tablets
Drug Approval | June 14, 2024

Zydus receives USFDA’s tentative approval for Azilsartan Medoxomil and Chlorthalidone Tablets

Azilsartan Medoxomil and Chlorthalidone Tablets had annual sales of US$ 77.9 mn in the United States (IQVIA MAT March 24).


Lilly's tirzepatide was superior to placebo for MASH resolution
Clinical Trials | June 13, 2024

Lilly's tirzepatide was superior to placebo for MASH resolution

SYNERGY-NASH results were presented at the European Association for the Study of the Liver Congress 2024 and simultaneously published in The New England Journal of Medicine


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


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


AbbVie receives positive CHMP opinion for Risankizumab for treatment ulcerative colitis
News | June 01, 2024

AbbVie receives positive CHMP opinion for Risankizumab for treatment ulcerative colitis

Ulcerative Colitis (UC) is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) affecting the large intestine


Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets
Drug Approval | May 30, 2024

Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death


Zydus receives final approval from USFDA for Theophylline ER Tablets
Drug Approval | May 25, 2024

Zydus receives final approval from USFDA for Theophylline ER Tablets

Theophylline is used to treat asthma and chronic obstructive pulmonary disease


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


Arvinas and Pfizer announce updated clinical data from Phase 1b Trial of Vepdegestrant in combination with Palbociclib
Clinical Trials | May 18, 2024

Arvinas and Pfizer announce updated clinical data from Phase 1b Trial of Vepdegestrant in combination with Palbociclib

At the recommended Phase 3 dose of 200 mg vepdegestrant in combination with palbociclib, patients achieved a median progression-free survival of 13.9 months