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

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

SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services

The inspection concluded with zero Form 483 observations

Lupin launches Prucalopride tablets in US

Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA

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

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

Teijin Pharma receives approval for additional indication for XEOMIN in Japan

Glenmark Pharmaceuticals launches TEVIMBRA in India

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