Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

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

Biocon Biologics secures US market entry date for Bosaya and Aukelso, Denosumab biosimilars

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

Enhertu improved in invasive disease-free survival in early breast cancer in DB-05

Second positive Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu in HER2-positive early breast cancer reinforces its potential to become a foundational treatment option in curative-intent setting

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.

Alkem launches pertuzumab biosimilar ‘Pertuza’ for treatment of HER2-positive breast cancer

Alkem's Pertuza is an affordable, indigenously-developed and manufactured biosimilar of pertuzumab

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

Poly Medicure acquires Italy’s Citieffe Group for Rs. 324 Cr

FDA responds to evidence of possible association between autism and acetaminophen use during pregnancy

Agency initiates safety label change and notifies physicians of possible link

CuraTeQ Biologics completes Phase 3 clinical study for Denosumab biosimilar

Conducted entirely in Europe across forty sites in five countries, this rigorous study met all clinical endpoints