Food and Drug Administration (FDA)
NEWS
May has been fruitful for research into the prevention and diagnosis of Alzheimer’s disease, the mechanisms behind early symptoms and potential treatments.
The FDA has extended the review period for Myfembree, following the supplemental New Drug Application from Pfizer and Myovant. Here’s more about this news.
Janssen’s COVID-19 vaccine is now limited to certain individuals ages 18 years and up after the FDA downgraded its emergency use authorization (EUA).
Novartis announced on Thursday that it will be temporarily and voluntarily suspending the production of its cancer therapeutics Lutathera and Pluvicto at facilities in Italy and New Jersey.
Illumina and Deerfield Management have entered into a five-year partnership to apply a genetic-led approach to the discovery and development of novel therapies.
BioCryst’s success of its Orladeyo launch in its Q1 report was overshadowed by the news that the FDA had placed a partial clinical hold on three of its clinical trials evaluating BCX9930
AstraZeneca and Daiichi Sankyo’s breast cancer therapeutic Enhertu received supplemental approval for an earlier form of breast cancer from the U.S. Food and Drug Administration.
The FDA’s reaction came after Pfizer CEO Albert Bourla said that physicians may give a second five-day course of Paxlovid if patients see a spike in their SARS-CoV-2 viral load.
The FDA has approved two of Phathom Pharmaceuticals’ products for bacterial illnesses in adults: Voquezna Triple Pak and Voquezna Dual Pak.
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