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

Lupin receives FDA approval for biosimilar Armlupeg

Armlupeg is indicated for decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs

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

Renalys Pharma reports major phase III success for Sparsentan in Japanese IgA nephropathy patients

The study, which enrolled 35 Japanese patients, evaluated the percent change from baseline in the 24-hour urine protein-to-creatinine ratio

Medtronic launches first 'intelligent' circular stapler to boost surgical precision, reduce leaks

The Signia Circular Stapler is the only circular stapler on the market with integrated leak testing and features designed to minimize risk

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

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

Sudeep Pharma eyes Rs. 895 crore fundraising from debut on bourses

The issue comprises a fresh issue of Rs. 95 crore and targeting a total raise of around Rs. 895 crore

Time Medical launches India’s first low-field TOF MRI for nationwide aneurysm screening

India presents one of the world’s largest untapped opportunities for neurovascular screening

Indian pharma sector poised for a global leap beyond generics: K. Raja Bhanu, DG, PHARMEXCIL

With US$ 30.46 billion in exports and robust manufacturing capabilities, the industry is poised to expand into high-value drugs while strengthening ESG and compliance standards