OR WAIT null SECS
November 05, 2021
The agency found Lagevrio (molnupiravir) to be safe and effective at reducing the risk of death and hospitalization for those with mild to moderate COVID-19 infections.
November 04, 2021
EMA has ended rolling review of bamlanivimab and etesevimab COVID-19 antibody treatments after Eli Lilly Netherlands BV withdraws from the review process.
October 29, 2021
Novavax has filed its COVID-19 vaccine for authorization in the UK and Australia.
EMA’s CHMP concluded that a booster dose of Moderna’s Spikevax vaccine may be considered in people aged 18 and older.
Genentech’s Susvimo (ranibizumab injection) is approved for intravitreal use via ocular implant for the treatment of neovascular age-related macular degeneration.
Otsuka has submitted an initial marketing authorization application to EMA for vadadustat as a treatment of anemia associated with CKD in adults.
MHRA has granted a license to Gedeon Richter for Ryeqo to treat moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
October 28, 2021
FDA has worked to clarify how drug development can gain from tapping into information in health care systems and claims databases.
October 22, 2021
EMA has recommended the marketing authorization of Trodelvy (sacitusumab govitecan) to treat patients with an aggressive form of breast cancer.
EMA has started its evaluation of further expanded use of Comirnaty in children aged between five years and 11 years old.