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The drug, suzetrigine, received the FDA's official stamp of approval Thursday to be sold as a 50-milligram prescription pill taken every 12 hours, according to a press release.
Earlier this month, the health regulator approved updated COVID-19 vaccines made by Pfizer and Moderna targeting the KP.2 variant. JN.1 was the dominant strain in the United States earlier this year.
On Aug. 22, the Food and Drug Administration (FDA) approved the updated mRNA vaccines developed by pharmaceutical companies Moderna and Pfizer-BioNTech for people 12 years and older and granted ...
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 ...
Drugs approved under the FDA Accelerated Approval Program still need to be tested in clinical trials using endpoints that demonstrate clinical benefit, and those trials are known as phase 4 confirmatory trials. If the drug later proves unable to demonstrate clinical benefit to patients, the FDA may withdraw approval.
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
Federal officials on Thursday approved a new type of pain pill designed to eliminate the risks of addiction and overdose associated with opioid medications like Vicodin and OxyContin. The U.S ...
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.