FDA

The FDA has expanded the label of Regeneron’s blockbuster eye therapy Eylea (aflibercept), allowing the administration of a higher 8-mg dose at up to 16-week intervals, the company announced Friday.

Gilead Sciences said on Monday the U.S. health regulator placed a clinical hold on studies of its blood cancer drug, just a month after the company scrapped a late-stage trial due to efficacy concerns.

Leqembi

The U.S. Medicare health plan on Thursday offered details of plans to collect patient data as a condition for reimbursement for Eisai Co. Ltd. and Biogen Inc.’s new Alzheimer’s drug Leqembi, should it win traditional U.S. approval as expected by July 6.

FDA

Thursday, the FDA denied Intercept Pharmaceuticals’ application for its obeticholic acid tablets, which the New Jersey biopharma was proposing to treat patients with pre-cirrhotic liver fibrosis due to non-alcoholic steatohepatitis.

FDA

Sarepta’s Elevidys, approved Thursday as the first gene therapy for Duchenne muscular dystrophy, has been priced at $3.2 million per patient, making it one of the world’s most expensive medicines.

Wednesday, the FDA denied Aldeyra Therapeutics’ application for ADX-2191 (methotrexate injection, USP), which the Massachusetts biotech was proposing to treat the rare eye cancer primary vitreoretinal lymphoma.

Gambia will make it mandatory for all pharmaceutical products from India to be inspected and tested prior to shipment from July 1, according to Gambian government documents reviewed by Reuters, the first known restrictions on national exports following the deaths of dozens of children linked to Indian-made cough syrups.

A panel of advisers to the U.S. Centers for Disease Control and Prevention (CDC) on Wednesday will vote on whether to recommend the use of recently approved vaccines from Pfizer and GSK to prevent severe respiratory syncytial virus (RSV) infections in older adults.

Eli Lilly

The U.S. Food and Drug Administration (FDA) on Tuesday approved Eli Lilly and partner Boehringer Ingelheim’s drugs Jardiance and Synjardy to treat type 2 diabetes in children.

FDA

Following the death of a patient, the FDA has placed a clinical hold on Arcellx’s iMMagine-1 Phase II trial of its T cell therapy for relapsed or refractory multiple myeloma. The company’s stock fell around 23% in pre-market trading Tuesday.