Regulatory
An FDA advisory committee agreed on Friday that Zevra Therapeutics had provided sufficient efficacy data supporting the approval of arimoclomol for Niemann-Pick disease type C.
GSK, Moderna and Pfizer are all looking at potential respiratory syncytial virus vaccine sales slumps thanks to recently updated CDC guidelines regarding the use of RSV shots in seniors.
Approved under the regulator’s accelerated pathway, Tecelra is also the first new synovial sarcoma therapy in more than a decade, according to Adaptimmune Therapeutics.
In pursuit of Merck’s blockbuster Keytruda, GSK’s Jemperli scored its own broad FDA label expansion, allowing its use in first-line endometrial cancer regardless of biomarker status.
The Genetic Metabolic Diseases Advisory Committee will meet on Friday to discuss Zevra’s modified scale to describe the efficacy of its drug candidate for the treatment of Niemann-Pick disease type C.
The FDA will have six months to review Vertex Pharmaceuticals’ suzetrigine, potentially the first new class of drugs for acute pain in more than 20 years, according to the company.
In addition to facing generic competition, Entresto is among the initial 10 drugs selected for the Inflation Reduction Act’s Medicare Drug Price Negotiation Program, with the maximum fair prices to be published by Sept. 1.
The BIOSECURE Act’s prohibition on doing business with China-based companies may have implications for biotech and biopharma markets on both sides of the Pacific.
AstraZeneca is seeking a fixed-duration approval for Calquence, which will allow patients with chronic lymphocytic leukemia to take breaks from the therapy and prevent excessive toxicities and drug resistance.
The regulator on Friday warned healthcare providers and patients about adverse events linked with dosing errors from compounded versions of Novo Nordisk’s weight-loss and diabetes drugs.
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