FDA
In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA’s decisions in 2024.
While the full impact of the Supreme Court decision remains unknown, the new regulatory landscape could be a net positive for drug developers.
Trump’s HHS pick, Robert F. Kennedy Jr., is an anti-vaccine campaigner who has previously said that he plans to gut the FDA on allegations of corruption and reduce the NIH’s headcount.
The FDA has followed in the footsteps of its European counterparts and granted accelerated approval to PTC Therapeutics’ gene therapy Kebilidi for AADC deficiency. It is the first approved gene therapy to be delivered directly to the brain.
In February 2024, the FDA put two Phase II studies of zelnecirnon under a clinical hold after a case of liver failure was deemed potentially related to the drug.
Leqembi’s sales continue to be underwhelming, according to analysts, who contend the companies’ Alzheimer’s disease therapy is being held back by barriers such as coverage, infusion centers and time to diagnosis.
Despite the PDUFA date being extended by three months for Merus’ zenocutuzumab, Truist Securities analyst Asthika Goonewardene in a Tuesday note to investors said the delay is not a cause for concern with an approval expected.
The FDA is set to decide on four promising therapies in the next two weeks, including a CAR T for acute lymphoblastic leukemia.
While an FDA advisory committee saw signals of efficacy for Lexicon Pharmaceuticals’ sotagliflozin, the panel of external experts found that the company did not provide enough data to support its drug application.
Wednesday’s update to the regulator’s drug shortage database is good news for Novo Nordisk, which has struggled to keep up with demand for the blockbuster GLP-1 drugs.
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