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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
The EC approved BMS’s Opdivo (nivolumab) as a complementary treatment to chemotherapy for adult patients with certain types of gastric or esophageal 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.
October 21, 2021
In addition to allowing booster shots of the Moderna and J&J vaccines, FDA approved heterologous booster shots.
FDA is expanding its Emerging Technology Program and providing more support for new drug applications that present advanced manufacturing technologies.
Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) is the first FDA approved interchangeable biosimilar for Humira.
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 15, 2021
The council voted 19–0 to recommend that FDA authorize booster doses of the Moderna COVID-19 vaccine for certain populations.