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October 29, 2021
The panel voted 17 to 0 to recommend that FDA grant Emergency Use Authorization for Pfizer-BioNTech’s COVID-19 vaccine in children aged 5 to 11 years old.
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's CHMP has approved two new manufacturing sites and a ready-to-use formulation of Comirnaty.
EMA has started its evaluation of further expanded use of Comirnaty in children aged between five years and 11 years old.
UK government has secured two new antiviral treatments for COVID-19, which may be rolled out in a national clinical study before the end of 2021.
October 21, 2021
FDA is expanding its Emerging Technology Program and providing more support for new drug applications that present advanced manufacturing technologies.
October 19, 2021
The council voted 19-0 to recommend that FDA authorize booster doses of the J&J COVID-19 vaccine just one day after granting Moderna a similar recommendation.
October 18, 2021
The Pharmaceutical Technology and BioPharm International editors host industry experts in serialization and aseptic processing.
October 15, 2021
The council voted 19–0 to recommend that FDA authorize booster doses of the Moderna COVID-19 vaccine for certain populations.