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August 13, 2020
The committee has given a positive opinion on the biosimilar bevacizumab for several cancer indications.
August 11, 2020
The guidance is intended to assist IND sponsors in determining the need for drug-drug interaction studies.
August 07, 2020
Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.
The company is working to ensure broad global access to its COVID-19 vaccine candidate, following approval from regulators.
Roche has received approval from the European Commission for Rozlytrek (entrectinib), its newest anti-cancer drug, for two indications.
The companies have agreements to supply its mRNA-based COVID-19 vaccine to Japan and Canada, pending regulatory approvals in those countries.
July 29, 2020
Celltrion Healthcare has announced that the EC has granted marketing authorization for its subcutaneous formulation of Remsima (infliximab, CT-P13).
July 24, 2020
Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies.
July 21, 2020
Should therapies and vaccines be cheap or free in a pandemic and would that really dry up innovation?
July 09, 2020
FDA officials are moving to clarify standards and requirements for vetting and approving viable preventives.