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 […]

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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.

The FDA greenlit AstraZeneca’s anti-CTLA-4 antibody tremelimumab in combination with its checkpoint inhibitor Imfinzi as a treatment for patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.

The U.S. Food and Drug Administration approved Sanofi’s Dupixent (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years and older, weighing at least 40 kg. With this approval, Dupixent is the first and only medicine specifically indicated to treat EoE in the United States.

The U.S. Food and Drug Administration announced the availability of a draft guidance aimed at increasing the amount of safety information the agency has about the dietary supplement marketplace by providing the industry an opportunity to submit late new dietary ingredient (NDI) notifications.

An advisory panel to the U.S. Centers for Disease Control and Prevention (CDC) is meeting on May 19 to discuss whether to recommend COVID-19 vaccine booster shots for children ages 5 to 11, a group that is just 29% vaccinated so far.

Reportedly, Pfizer is holding the company’s COVID-19 antiviral therapy Paxlovid under tight control. This is a disappointment to numerous investigators who want to test the antiviral combination therapy with other drugs in case the virus develops resistance to the combo.

U.S. House Democrats on May 17 unveiled a bill to provide $28 million in emergency funds to the Food and Drug Administration to help the regulatory agency respond to a nationwide shortage of infant formula and strengthen supervision of the industry.