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9359 News Found

Merck announces first patient dosed in Phase III study of Oral Cladribine in gMG
News | September 02, 2024

Merck announces first patient dosed in Phase III study of Oral Cladribine in gMG

MyClad is a global Phase III study evaluating the efficacy and safety of cladribine capsules for the treatment of generalized Myasthenia Gravis (gMG)


Biocon Pharma receives USFDA approval for daptomycin
Drug Approval | September 01, 2024

Biocon Pharma receives USFDA approval for daptomycin

The approval further adds to Biocon’s portfolio of complex drug products


Zydus receives warning letter from USFDA for Jarod injectables manufacturing facility
Drug Approval | August 31, 2024

Zydus receives warning letter from USFDA for Jarod injectables manufacturing facility

The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility


Thyrocare to acquire diagnostic and pathological services business of Vimta Labs
News | August 31, 2024

Thyrocare to acquire diagnostic and pathological services business of Vimta Labs

Vimta Labs through its diagnostic and pathological services business has recorded a revenue of Rs. 30 crores during FY 2024 and Rs. 7 crores in Q1 FY 2025


Bayer starts Phase III trial in non-small cell lung cancer
Clinical Trials | August 30, 2024

Bayer starts Phase III trial in non-small cell lung cancer

First patient enrolled in the Phase III SOHO-02 trial of investigational agent BAY 2927088 in treatment-naïve patients with advanced NSCLC with HER2-activating mutations


Natco Pharma announces submission of TABRECTA to USFDA
Drug Approval | August 30, 2024

Natco Pharma announces submission of TABRECTA to USFDA

TABRECTA is the brand of Novartis. Natco believes it is the first company to have filed a substantially-complete ANDA


Suven Life Sciences announces FDA acceptance of investigational new drug
Drug Approval | August 30, 2024

Suven Life Sciences announces FDA acceptance of investigational new drug

First-in-human Phase-1 study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SUVN-I6107 in healthy subjects


Lupin receives USFDA approval for Brimonidine Tartrate Ophthalmic Solution, 0.1%
Drug Approval | August 28, 2024

Lupin receives USFDA approval for Brimonidine Tartrate Ophthalmic Solution, 0.1%

Brimonidine Tartrate Ophthalmic Solution, 0.1% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure