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August 24, 2021
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.
The user fees set for fiscal year 2022 are noteworthy, as their announcement comes as FDA and industry are finalizing agreements for new five-year user fee programs.
FDA granted orphan drug designation to Paratek Pharmaceuticals for NUZYRA (omadacycline), an investigational antibiotic.
Bristol Myers Squibb has exercised the option to in-license an immune-modulating drug candidate developed by Exscientia.
3P Innovation has won a Princess Royal Training Award for its Graduate Development Programme (GDP).