USFDA

The U.S. Food and Drug Administration today approved a new indication for Breyanzi (Lisocabtagene maraleucel) as the first Chimeric Antigen Receptor (CAR) T-cell therapy in the U.S. for treatment of adults with marginal zone lymphoma (MZL) who have failed treatment with or relapsed after two or more prior lines of therapy.

The U.S. Food and Drug Administration (FDA) has announced new measures aimed at accelerating the development of biosimilar medicines and lowering the overall cost of biologic treatments in the United States.

Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received tentative approval from the United States Food and Drug Administration (USFDA) for Budesonide delayed-release capsules, 4 mg (USRLD: Tarpeyo Capsules, 4 mg).

The U.S. Food and Drug Administration today announced actions to restrict the sale of unapproved ingestible fluoride prescription drug products for children. The FDA sent notices to four companies outlining the agencys intention to take enforcement action against those marketing unapproved fluoride-containing ingestible drugs labeled for use in children under age 3 or older children at low or moderate risk for tooth decay.

GSK plc announced the US Food and Drug Administration (FDA) has approved Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent.

The U.S. Food and Drug Administration (FDA) has acknowledged reports of severe and ongoing contamination involving diethylene glycol (DEG) and ethylene glycol (EG) in children’s cough and cold medicines in India. The agency confirmed that these contaminated products have not been shipped to the United States.

PrecisionSphere™ demonstrates efficacy and safety in drug delivery and is ready for commercial use, following the recent United States Food and Drug Administration’s (U.S. FDA) approval for the first product developed with this platform.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the supplemental New Drug Application (sNDA) for the use of REXULTI® (brexpiprazole) in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD).