FDA supports new ANDA prioritization pilot to support US generic drugs

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial

Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections

This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company

Leqembi wins NMPA nod for once-monthly IV dosing in early Alzheimer’s patients

LEQEMBI was initially approved in China in January 2024 for the treatment of Alzheimer’s disease in patients with mild cognitive impairment

DMMA warns regulatory burden threatening Gujarat’s pharma MSMEs

The association called for an end to the constant issuance of regulatory circulars that make operations unpredictable and capital-intensive.

Glenmark signs cancer drug licensing deal with Hengrui Pharma for $18 million upfront payment

Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion

AstraZeneca’s Tezspire recommended for approval in the EU for chronic Rhinosinusitis with nasal polyps

Tezspire nearly eliminated the need for surgery, reducing surgical intervention by 98 per cent

Merck opens €150 million manufacturing facility in Ireland

Merck opens first climate-neutral manufacturing facility in Ireland

Atom enrolls first patient in global phase 2 trial of ABP-745 for acute gout flares

ABP-745 is a novel oral therapy with potential applications in cardiovascular and other inflammatory diseases

Dr. Reddy’s launches novel molecule ‘Tegoprazan’ in India

Tegoprazan, a novel patented molecule indicated for acid-related gastrointestinal diseases, is launched in India under the brand name PCAB