Here are the latest stories being discussed in biopharma today:

FDA Advisory Committee Supports Carvykti for Earlier-stage Multiple Myeloma

Johnson & Johnson and Legend Biotech’s CAR-T therapy Carvykti received unanimous support from an FDA advisory committee for its benefits for earlier-stage multiple myeloma patients, surpassing concerns about higher death rates in the early stages of treatment.

Bristol Myers Earns Accelerated FDA Approval for Breyanzi

Bristol Myers Squibb’s CAR-T cell therapy, Breyanzi, was granted accelerated FDA approval for treatment of adults with refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Breyanzi is already approved in the US, Japan, and Europe for second-line treatment of relapsed or refractory large B-cell lymphoma.

FDA Unveils Strategy for Regulating AI in Medical Products

The FDA has outlined its regulatory strategy for artificial intelligence in medical products. Developed in conjunction with the agency’s biologics, drug, and device centers and the Office of Clinical Pharmacology, the plan focuses on educating patients and healthcare providers and streamlining approaches to AI with global collaborators.

Moderna Initiates Campaign on Long Covid

Moderna’s latest initiative focuses on the often overlooked condition of Long Covid, with a digital campaign and free CT scans for research purposes launching. The company urges individuals to understand that the only way to prevent Long Covid is to avoid contracting Covid in the first place.

Chief Medical Officer Leaves Biogen

Biogen loses Chief Medical Officer Maha Radhakrishnan after four years. Toby Ferguson, the head of the company’s neuromuscular development unit, will also depart to become CMO for Voyager Therapeutics.

BeiGene’s PD-1 Inhibitor Secures FDA Approval

BeiGene won FDA approval for its PD-1 inhibitor Tevimbra, marking a significant milestone after a winding and delayed regulatory process. The drug will be available in the US in the second half of 2024, to treat metastatic esophageal squamous cell carcinoma (ESCC) after prior chemotherapy.