Briefs: Neuland Laboratories and Granules India

Granules India receives 1 observation from USFDA for Chantilly facility

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

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

UFlex introduces FSSAI compliant single-pellet solution for food packaging

UFlex is the first and only Indian company to receive USFDA approval for its technology and capacity to recycle all three materials

Briefs: Hikal and Sun Pharma

Sun Pharma gets 8 observations from USFDA for Halol facility

FDA approves AbbVie’s mavyret as first and only treatment for acute hepatitis C

Now approved for both acute and chronic HCV in adults and children aged 3 and above

Zydus receives EIR for the API manufacturing facility at Ankleshwar and Dabhasa

Zydus receives EIR for the API manufacturing facility at Ankleshwar

FDA approves Merck’s enflonsia for prevention of RSV in infants

Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months

SeQuent–Viyash merger receives stock exchange approvals; NCLT filing underway

Bayer’s Sevabertinib granted FDA priority review for the treatment of patients with HER2-mutant non-small cell lung cancer

This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition