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

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

Investors pile in as Cordance secures oversubscribed seed round for brain-cancer tech

The fresh capital will propel Cordance into its first-in-human clinical trial

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

Bengaluru makes medical history with first robot-assisted deceased donor kidney transplant

Deceased donor kidney transplants are time-critical, and it is uncommon to attempt them robotically

India becomes first country to approve STIMULAN Rapid Cure with antifungals

Surgical site infections and antimicrobial resistance remain major challenges globally

Novartis scores FDA nod for game-changing SMA treatment

Itvisma is a one-time, fixed-dose therapy designed to tackle the genetic root cause of SMA

Telangana fires up biologics innovation, debuts India's first single-use bioprocess scale-up hub

The State’s PPP model has already mobilised Rs. 150 crore in core infrastructure, while Thermo Fisher has invested Rs. 90 crore in the Bioprocess Design Centre and its co-located Customer Experience Centre

Thermo Fisher opens two new centers in Hyderabad

The new Bioprocess Design Center will serve as a cutting-edge scale-up hub for biologics and vaccine manufacturing

FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures

Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels