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

EMA starts review of sodium oxybate in alcohol dependence

Review will evaluate effectiveness in treating alcohol withdrawal syndrome and supporting abstinence, as well as measures to mitigate risk of abuse

Biocon Biologics receives Health Canada approval for Yesafili

The approval is based on a comprehensive package of analytical, nonclinical, and clinical data

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

Dr. Lal PathLabs strengthens its genomics capabilities with Illumina's NovaSeq X Series

The NovaSeq X system features Illumina's cutting-edge XLEAP-SBS chemistry, offering unmatched throughput, accuracy, and sustainability

Ashland expands viatel bioresorbable polymers offering for medical devices

Viatel bioresorbable polymers are increasingly used in dental and orthopedic implants

Teijin Pharma receives approval for additional indication for XEOMIN in Japan

Covestro launches localized production of medical-grade TPU in Asia Pacific

Changhua site meets international regulatory standards for global medical applications

Glenmark Pharmaceuticals launches TEVIMBRA in India

TEVIMBRA is a uniquely designed anti-PD-1 monoclonal antibody developed by BeiGene (now BeOne Medicines)

Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma

J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA