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April 23, 2021
Executives that participated in the CPhI post-pandemic survey are predicting a push for repatriation of manufacturing globally.
April 21, 2021
The White House sent Congress a summary of “topline” funding requests that continue efforts to combat the coronavirus pandemic and to restore the nation’s economic health.
April 20, 2021
FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant.
April 19, 2021
The agency revoked EUA status for the monoclonal antibody bamlanivimab to be administered alone to treat mild-to-moderate COVID-19.
April 16, 2021
The agency will use technology for “voluntary remote interactive evaluations” for pre- and post-approval and other types of inspections.
BMS has announced that the EC has approved Opdivo in combination with Cabometyx for the first-line treatment of adults with advanced renal cell carcinoma.
EMA's Pharmacovigilance Risk Assessment Committee is reviewing very rare cases of unusual blood clots in the US, following administration of Janssen’s COVID-19 vaccine.
EMA is continuing to monitor the incidences of very rare blood clots with low blood platelets occurring after vaccination with the AstraZeneca COVID-19 vaccine (Vaxzevria).
EMA has started its review of monoclonal antibody VIR-7831 (also known as GSK4182136) as a treatment for patients with COVID-19.
Biogen UK has announced that the UK’s MHRA and the EC have granted marketing authorization for the subcutaneous (SC) formulation of Tysabri (natalizumab).