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The FDA unveiled a final guidance yesterday on referencing approved drug products in Abbreviated New Drug Application (ANDA) submissions that seeks to clear up confusion commenters expressed about draft guidance the agency issued Jan. 17, 2017. Read More
Novavax has announced that it will start a late-stage clinical trial of its investigational COVID-19 vaccine in the U.S. by the end of November. Read More
The FDA will not make COVID-19 vaccine developers go through pre-approval inspections for an Emergency Use Authorization (EUA), but companies will have to submit detailed manufacturing data and meet certain other requirements, said a senior official in the Center for Biologics Evaluation and Research (CBER). Read More
Pfizer CEO Albert Bourla announced Tuesday that the company won’t have the necessary phase 3 trial data required to submit its COVID-19 vaccine candidate for Emergency Use Authorization (EUA) this month, despite previous projections. Read More
The FDA cited MasterPharm following an inspection of its South Richmond Hill, N.Y. plant that revealed numerous violations of current good manufacturing practices. Read More
The FDA announced that a memorandum of understanding (MOU) between the agency and states for regulating traditional compounding pharmacies that distribute their products to other states is now available for signature by state health agencies. Read More
Bayer will pay up to $4 billion to acquire North Carolina-based gene therapy company Asklepios BioPharmaceutical (AskBio) in a move that will extend the German pharma giant’s reach into regenerative therapies. Read More