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July 02, 2022
A new strategy aims to bring in legislative reforms that will impact medicinal product regulation within Europe.
Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.
June 30, 2022
Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.
June 29, 2022
The European Commission has approved Cosentyx for the treatment of various childhood arthritic conditions.
The European Commission has approved Xenpozyme as the first treatment for ASMD.
The action plan will span over five years and will fulfill a requirement of the Accelerating Access to Critical Therapies for ALS Act.
June 27, 2022
Regulators wish to expand and clarify methods for obtaining information on medicines used by or needed for pregnant and lactating individuals through clinical trials and postapproval studies.
The new guidance outlines the approach the MHRA intends to take for products approved or pending in a decentralized procedure or mutual recognition procedures.
June 22, 2022
FDA is at a pivotal moment because of important gains in medical treatment based on science.
June 17, 2022
Measure tackles infant formula, cosmetics, diagnostics plus drug development and access.