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May 24, 2022
AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.
EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union.
May 17, 2022
In this episode of the Drug Solutions Podcast, Chris Spivey, editorial director, interviews Michael Kopcha, Sau Lee, and Cindy Buhse of FDA about not being afraid to try new approaches and how they invite fresh ideas and abundant communication.
May 11, 2022
The agency’s Center for Drug Evaluation and Research has launched the new program to increase development of treatment options for patients with rare diseases.
The drug is the first immunomodulatory COVID-19 treatment approved by FDA.
May 03, 2022
FDA has issued the final guidance on electronic postmarketing safety reports in a series of guidance documents.
May 02, 2022
The move toward using the Digital Application Dataset Integration (DADI) project for the initial implementation of IDMP-based regulatory data submissions offers both opportunities and challenges for pharmaceutical organizations.
What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?
April 22, 2022
FDA is requesting comment on draft document “Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange.”
March 21, 2022
Moderna, Pfizer, and BioNTech are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines.