Camurus’ Oclaiz NDA resubmission accepted by FDA

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026

Briefs: APL Healthcare, Biocon, USFDA, Sun Pharma and Clean Fino-Chem

USFDA determines Sun Pharma's Baska facility inspection classification as OAI

FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease

Briefs: IOL Chemicals & Pharmaceuticals, Ipca Laboratories and Anuh Pharma

Ipca Laboratories receives three observations from USFDA for API facility at Tarapur

Innoxel Lifesciences completes EU GMP inspection by Belgium's FAMHP

The audit was completed with zero critical and zero major observations

Enlivex reports promising six-month data for Allocetra in knee osteoarthritis

Call it a ray of hope for those enduring the pain of knee osteoarthritis -- the most common form of arthritis, affecting over 300 million people worldwide

Solara’s Mangalore facility clears FDA inspection with VAI status

Briefs: Zydus, Divi's Laboratories and Relonchem

FDA closes inspection at Zydus' oncology injectable manufacturing facility in SEZ1, Ahmedabad with 2 observations

Senores Pharma forms new subsidiary in US

Senores Pharmaceuticals (SPI) acquired 51% stake in Zoraya Pharmaceuticals

Advances in genetic testing, fertility preservation, and ART are reshaping reproductive care across India: Dr. Umesh N Jindal, Director, Jindal IVF

Dr. Jindal reflects on bridging accessibility gaps between urban and rural regions, the ethical and emotional aspects of family building, and how initiatives like adoption facilitation centers align with his lifelong mission to help couples realize the dream of parenthood