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The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form.
GoodRx released a list of 19 of the most influential drugs and vaccines approved by the FDA in 2024 to treat a variety of conditions. These medications are “slated to make a big clinical impact."
The approval is based on a late-stage study in which PiaSky showed a 79.3% control in the destruction of red blood cells versus 79% for the standard-of-care eculizumab from week 5 to week 25.
Treatment of adults with locally advanced, unresectable (stage III) non- small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test [2]
The oral drug, branded as Miplyffa, has now been approved for the treatment of Neimann-Pick disease type C - a rare genet US FDA approves Zevra's treatment for rare genetic disease Skip to main ...
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...
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National regulatory authorities have granted full or emergency use authorizations for 40 COVID-19 vaccines.. Ten vaccines have been approved for emergency or full use by at least one stringent regulatory authority recognized by the World Health Organization (WHO): Pfizer–BioNTech, Oxford–AstraZeneca, Sinopharm BIBP, Moderna, Janssen, CoronaVac, Covaxin, Novavax, Convidecia, and Sanofi ...