The U.S. Food and Drug Administration on Wednesday approved Johnson & Johnson unit Actelion Pharmaceuticals’ injection, making it the first-ever treatment to treat severe frostbite in adults.


The FDA on Tuesday approved Ipsen’s Onivyde, when used in combination with three chemotherapeutic drugs, for the treatment of newly diagnosed patients with metastatic pancreatic adenocarcinoma.

Zealand Pharma said on Saturday that the U.S. Food and Drug Administration (FDA) had declined to approve its drug for preventing and treating low blood sugar in children with a genetic disorder after finding deficiencies at a third-party manufacturing facility.

Advisers to the U.S. Food and Drug Administration on Thursday will discuss and vote on whether to recommend targeting one of the currently dominant XBB coronavirus variants in updated COVID-19 shots being developed for a fall vaccination campaign.

U.S. Supreme Court Justice Samuel Alito on Wednesday extended by two days a temporary block on limits set by lower courts on access to the abortion pill mifepristone in a challenge by anti-abortion groups to the drug’s federal regulatory approval.


After the flurry of verdicts and meetings at the end of February, the FDA has a relatively quiet week ahead with only two stand-out events.

FDA, stop sign

The FDA put 4D Molecular Therapeutics’ gene therapy program, 4D-310, on clinical hold, the company announced February 2.

The FDA granted Eli Lilly’s Jaypirca (pirtobrutinib) accelerated approval for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL), the company announced Friday.

GlaxoSmithKline, GSK

GSK’s oncology business suffers fresh blow with Zejula setback By Natalie Grover and Pushkala Aripaka Nov 11 (Reuters) – Britain’s GSK (GSK.L) said on Friday it would limit the use […]

SOBI logo

Sobi North America, a unit of Swedish Orphan Biovitrum AB , said on Thursday the U.S. Food and Drug Administration authorized its arthritis drug for treatment of high-risk hospitalized COVID-19 patients.