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Results For "regulatory-authority"

58 News Found

Venus Remedies gets marketing authorization for Ceftriaxone in Argentina
Drug Approval | May 07, 2026

Venus Remedies gets marketing authorization for Ceftriaxone in Argentina

Approval strengthens the company’s growing international anti-infective portfolio


Alkem Laboratories receives 7 observations following US FDA inspection at Daman facility
Drug Approval | May 04, 2026

Alkem Laboratories receives 7 observations following US FDA inspection at Daman facility

The US regulator conducted an inspection at the Amaliya manufacturing plant between April 20 and May 1, 2026


Eli Lilly flags counterfeit Mounjaro products in Gurugram, backs regulatory action
Supply Chain | April 30, 2026

Eli Lilly flags counterfeit Mounjaro products in Gurugram, backs regulatory action

Company confirms seized products were not from its authorised supply chain and urges patients to purchase medicines only through licensed pharmacies


Eli Lilly flags counterfeit Mounjaro seizure in Gurugram
News | April 20, 2026

Eli Lilly flags counterfeit Mounjaro seizure in Gurugram

The company said it is supporting the ongoing investigation and reiterated its commitment to patient safety.


Curatis and Neupharma strike major deal to bring brain tumor therapy to Japan
News | March 14, 2026

Curatis and Neupharma strike major deal to bring brain tumor therapy to Japan

Neupharma gains exclusive rights to develop and commercialize corticorelin for peritumoral brain edema


FDA accepts Teva’s NDA for long-acting schizophrenia injection
Drug Approval | February 21, 2026

FDA accepts Teva’s NDA for long-acting schizophrenia injection

If approved, TEV-'749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations


Sanofi’s Venglustat shows breakthrough results in rare neurological Gaucher disease
Clinical Trials | February 04, 2026

Sanofi’s Venglustat shows breakthrough results in rare neurological Gaucher disease

Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs


Wockhardt files marketing authorisation application for WCK 5222 with EMA
News | January 08, 2026

Wockhardt files marketing authorisation application for WCK 5222 with EMA

WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation


EMA grants orphan drug status to Sanofi’s Efdoralprin Alfa for rare lung disease
Drug Approval | December 20, 2025

EMA grants orphan drug status to Sanofi’s Efdoralprin Alfa for rare lung disease

Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD


UK MHRA finds gut microbiome research unreliable across labs
R&D | November 14, 2025

UK MHRA finds gut microbiome research unreliable across labs

False positive rates?ranged from 0% to 41%, meaning some labs incorrectly identified bacteria that weren’t present in the sample