OR WAIT null SECS
August 25, 2021
Lonza plans to establish drug product manufacturing capabilities at is site in Guangzhou, China, to produce clinical trial and commercial supply in the country.
August 24, 2021
FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine raises hopes that this action will help overcome vaccine hesitancy.
FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.
HHS Public Health and a team of medical experts recommend that COVID-19 vaccine booster shots will soon be necessary.
FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.
August 23, 2021
Director-General Tedros Adhanom Ghebreyesus is concerned booster shots could limit supply for countries struggling to get first and second vaccine doses.
August 20, 2021
MHRA has approved Moderna’s COVID-19 vaccine for use in 12–17-year-olds.
Novartis' Cosentyx has been granted further approval from the China National Medical Products Administration for use in pediatric patients.
ICMRA has published a report setting out recommendations on how regulators should address the issues that the use of AI poses to global medicines regulation.
EMA has started evaluating RoActemra (tocilizumab), an anti-inflammatory medicine, as a potential treatment for hospitalized adult patients with severe COVID-19.