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522 News Found

FDA lifts hold on Rocket Pharma's gene therapy trial
News | August 22, 2025

FDA lifts hold on Rocket Pharma's gene therapy trial

Rocket will also collaborate with investigators to implement an immunomodulatory regimen more closely reflecting that administered in the Phase 1 pediatric cohort


BioAge Labs doses first patient in BGE-102 phase 1 trial
Biotech | August 19, 2025

BioAge Labs doses first patient in BGE-102 phase 1 trial

The randomized, double-blind, placebo-controlled Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102 in healthy participants


European Commission grants approval of Ogsiveo
News | August 18, 2025

European Commission grants approval of Ogsiveo

OGSIVEO is the first and only therapy to receive marketing authorization in the EU for the treatment of desmoid tumors


Zydus Lifesciences reports Q1 FY26 net profit at Rs. 1,466.8 Cr
News | August 13, 2025

Zydus Lifesciences reports Q1 FY26 net profit at Rs. 1,466.8 Cr

The company reported revenue from operations at Rs. 6,573.7 crore, up 6 per cent YoY


Boehringer’s lung cancer medicine gets FDA approval
Drug Approval | August 12, 2025

Boehringer’s lung cancer medicine gets FDA approval

FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC


Gland Pharma receives FDA approval for Cangrelor for Injection 50 mg/vial
Drug Approval | August 12, 2025

Gland Pharma receives FDA approval for Cangrelor for Injection 50 mg/vial

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA


ZIM Laboratories granted marketing authorization for Tamsulosin + Dutasteride capsules in Australia
News | August 08, 2025

ZIM Laboratories granted marketing authorization for Tamsulosin + Dutasteride capsules in Australia

Tamsulosin, an alpha-1 adrenergic receptor blocker, combined with Dutasteride, a dual 5- alpha-reductase inhibitor, is indicated for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH) in adult men


Vertex faces regulatory delays for Journavx and reports VX-993 Phase 2 trial failure
News | August 06, 2025

Vertex faces regulatory delays for Journavx and reports VX-993 Phase 2 trial failure

Treatment with the selective NaV1.8 pain signal inhibitor VX-993 after bunionectomy surgery did not meet the primary endpoint


Johnson & Johnson submits additional data to FDA on psoriatic arthritis
News | August 03, 2025

Johnson & Johnson submits additional data to FDA on psoriatic arthritis

The submission is supported by results from the Phase 3b APEX study


GlaxoSmithKline Pharmaceuticals reports Q1 FY26 PAT at Rs. 205 Cr
News | August 03, 2025

GlaxoSmithKline Pharmaceuticals reports Q1 FY26 PAT at Rs. 205 Cr

The performance was below anticipated levels, primarily due to external factors such as seasonal disruption that affected overall results