Briefs: Medicamen Biotech, Aurobindo Pharma and Ajooni Biotech

The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility

Zydus Lifesciences announces completion of Phase II(a) clinical trial of Usnoflast

ALS patients experience neuroinflammation and rapid neurodegeneration

Briefs: Ami Organics and Dr. Reddy’s Laboratories

Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.

Lupin launches Doxorubicin Hydrochloride Liposome Injection in US

ForDoz Pharma Corporation, USA (ForDoz) received an approval for its ANDA from the USFDA

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

Shilpa Medicare announces positive outcome of Phase 3 studies of NorUDCA

Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India

Alembic receives FDA final approval for Betamethasone Valerate Foam, 0.12%

Wanbury receives EIR from FDA for Patalganga facility

USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation

Pfizer and BioNTech receive FDA authorization for Omicron KP.2-adapted Covid-19 Vaccine

The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older

Granules India receives ANDA approval for Glycopyrrolate Oral Solution

Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients