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August 27, 2021
FDA granted orphan drug designation for imatinib in AER-901 for the treatment of patients with pulmonary arterial hypertension.
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FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.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
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.
FDA granted orphan drug designation to Paratek Pharmaceuticals for NUZYRA (omadacycline), an investigational antibiotic.
August 18, 2021
Lilly’s insulin, lyumjev, receives FDA approval for an expanded label.