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January 21, 2021
The approval was based on positive results from a single-arm Phase II trial where the treatment demonstrated significant antitumor activities in patients with the disease.
January 14, 2021
A report on the FDA PREPP initiative’s work in 2020 aims to strengthen the Agency’s response to future public health emergencies.
As the Biden administration readies to take over the reigns of government, top administration officials continue to rush through new rules and decisions that appear to challenge the independence and effective operations of FDA.
January 11, 2021
The draft guidance document offers developers of these treatments information regarding product development, preclinical testing, and clinical trial design.
January 07, 2021
The vetting and authorizing of important new therapies remained productive in 2020, despite the need to devote considerable resources to dealing with COVID-19 related approvals and policies.
The European Commission has granted a conditional marketing authorization to Moderna for its COVID-19 vaccine.
January 05, 2021
Amid pressure to get more vaccines administered faster, FDA pushes back against changes in dosing regimens.
January 03, 2021
FDA approval rate speeds up despite COVID-19 complications.
January 02, 2021
The number of recommendations for European marketing authorization of human medicines saw significant increase in 2020 over the previous year.
December 31, 2020
Commissioner Stephen Hahn evaluates the agency’s response to COVID-19 and how it affected non-COVID related initiatives in 2020.