Zydus receives EIR for the injectable facility located at Jarod

This inspection was conducted following the warning letter issued by the USFDA

LENZ Therapeutics, Lotus Pharmaceutical submit NDA for presbyopia treatment in Korea

Presbyopia, the age-related loss of near vision, could soon be treated successfully

FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich

This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA

Ascendis Pharma’s FDA review of Achondroplasia drug gets 3-month delay

The FDA has classified recent submissions as a major amendment pushing the approval to its NDA for TransCon CNP back three months to February 28, 2026

Biocon Biologics' Drug Substance Facility in Bengaluru cassified as VAI

This relates to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States

Innoxel Lifesciences completes EU GMP inspection by Belgium's FAMHP

The audit was completed with zero critical and zero major observations

SMS Pharmaceutical's associate company receives FDA approval for reformulated Ranitidine

The approval by the US FDA comes after extensive safety testing and manufacturing improvements

Glenmark Pharma gets VAI from FDA for Monroe facility

The positive outcome clears the way for Glenmark to resume commercial manufacturing at the site

EU greenlights Dupixent for chronic urticaria, offering new hope to patients

It's a development that marks a major step forward for patients struggling with moderate-to-severe chronic spontaneous urticaria

Zydus receives FDA’s tentative approval for Empagliflozin and Linagliptin tablets

Teva breaks ground with EU approval for two key bone disease biosimilars

EU clears Bristol Myers Squibb’s CAR-T therapy Breyanzi for tough-to-treat Lymphoma

The European Commission’s green light marks Breyanzi’s fourth indication in Europe and extends access to patients across all EU and EEA countries

Merck KGaA’s Cladribine capsules gain FDA fast track for rare neuromuscular disorder

Zydus receives FDA’s final approval for Verapamil Hydrochloride ER tablets

FDA nod to groundbreaking bladder cancer combo therapy for surgery patients

Call it a major milestone in bladder cancer therapy that aims to provide a lifeline for patients who previously had limited options

Marksans Pharma Inc. receives USFDA approval for Loperamide Hydrochloride Tablets

Loperamide Hydrochloride is an anti-diarrheal medication used to control symptoms of acute and chronic diarrhoea

Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla

The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia

Lupin receives 7 observations from USFDA for Goa manufacturing facility

Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe

NATCO Pharma receives 7 observations from USFDA for API unit at Manali

Alvotech and Advanz Pharma secure European nod for Gobivaz, first biosimilar to Simponi

Gobivaz is authorised for adults with rheumatoid arthritis (in combination with methotrexate), psoriatic arthritis (with or without methotrexate), axial spondyloarthritis, and ulcerative colitis