Briefs: Neuland Laboratories and Granules India

Granules India receives 1 observation from USFDA for Chantilly facility

Sartorius expands manufacturing and R&D capacities for bioprocess solutions in France

Extended lab space for product development, customer demos, and training

Zambon launches intravenous formulation of Fluimucil

The approval in China is supported by a robust local clinical development program confirming the drug’s safety, tolerability, and efficacy profile

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

Shukra Pharmaceuticals receives LoA from RMSCL

The company has been awarded a contract for the supply of essential pharmaceutical formulations to government health institutions across Rajasthan

European Commission approves Eylea 8 mg with extended 6-month treatment interval for nAMD and visual impairment due to DME

Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME

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)