FDA approves removal of REMS programs within Bristol Myers Squibb’s cell therapy labels

Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access

Philogen withdraws marketing authorization application for Nidlegy in EU

The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls

Biocon concludes a Rs 4,500 crore equity fundraise through QIP

The proceeds from the QIP will be utiized for purchase of outstanding optionally convertible debentures

USFDA concludes inspection of NATCO’s Pharma Division, Kothur

The company received seven observations in the Form-483

USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad

The company received one observation in the Form-483

Mezzion secures $20 million funding to advance Phase 3 clinical development of Udenafil for fontan patients

USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad

The company received 1 (One) observation in the Form-483

Sun Pharma appoints Kirti Ganorkar as the Managing Director

Dilip Shanghvi to continue as the Executive Chairman of the Board

Boehringer Ingelheim and Eko Health collaborate to improve heart murmur detection in dogs

The partnership combines Boehringer’s expertise in canine cardiology with Eko’s digital stethoscopes and AI algorithms

Brenntag Specialties acquires mcePharma to cater growing demand in Biopharma market

The acquisition sets up the foundation for a central hub of GMP value-added services and greater access to new customers in the rapidly growing Biopharma market