Search results
Results from the WOW.Com Content Network
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 ...
Vasculitis [3] Alpidem (Ananxyl) 1995. Worldwide. Not approved in the US, withdrawn in France in 1994 [4] and the rest of the market in 1995 because of rare but serious hepatotoxicity. [3][5] Alosetron (Lotronex) 2000. US. Serious gastrointestinal adverse events; ischemic colitis; severe constipation. [2]
The idea is that countries with non-SRA drug authorities can use accelerated process to facilitate approval (registration or marketing authorization) of medicines, including vaccines and biologics, which have already been approved by SRAs. [1] As of 2022, the national regulatory authorities of 36 countries are considered SRAs: [2]
Amgen. non-small cell lung cancer with KRAS G12C mutation. Avapritinib. Blueprint Medicines Corp. granted for two indications: mast cell leukemia and advanced systemic mastocytosis. Belumosudil. Kadmon Pharmaceuticals. chronic graft-versus-host disease. Pembrolizumab.
[54] [55] [198] [17] It was approved for use in Canada in September 2022. [59] [199] [22] In October 2022, the FDA amended the authorization for the bivalent booster to cover people aged six years of age and older. [200] In December 2022, the FDA amended the authorization for the bivalent booster to cover people aged six months and older. [201]
List of Antiviral Drugs Antiviral Use Manufacturer Component Type Year approved Abacavir: HIV: ViiV Healthcare: Nucleoside analogue reverse transcriptase inhibitor (NRTI) 1998 Acyclovir (Aciclovir) Herpes Simplex, chickenpox, [2] varicella zoster virus: guanosine analogue RTI 1981 Adefovir: Hepatitis B [3] Gilead Sciences RTI 2002 , 2003 Amantadine
In January 2022, the FDA gave regulatory approval to Veklury for use in adults and children (12 years of age and older who weigh at least 40 kilograms (88 lb) and are positive for COVID-19, not hospitalized, and are ill having high risk for developing severe COVID-19, including hospitalization or death. [135]
In 2022 Congress investigated the accelerated passage and approval of the Alzheimers drug Aduhelm, manufactured by Biogen and being marketed at $56,000 per patient a year. Although the FDA usually follows an advisory committee's recommendation, the investigation found that the FDA decided to consider it under the accelerated approval pathway ...