OR WAIT null SECS
April 07, 2023
The agency is dealing with high demand for staff because of a surge in the development of cell and gene therapies.
FDA aims to address mounting criticisms of its accelerated approval pathway.
April 02, 2023
New child-friendly treatment options and initiatives are improving the outlook of children living with HIV in Europe.
Proposed regulatory changes signal a major overhaul of legislation governing pharmaceuticals and healthcare in Spain.
A further setback to the publication of the pharmaceutical legislative changes in Europe may mean time is running out for appropriate review before 2024 parliamentary elections.
March 31, 2023
FDA has approved Evkeeza for young children with homozygous familial hypercholesterolemia.
March 30, 2023
Takeda received approval in Japan for a subcutaneous injection formulation of Entyvio (vedolizumab) for treating ulcerative colitis.
March 29, 2023
Narcan, from Emergent Solutions, will be the first naloxone product permitted for use without prescription by FDA.
March 24, 2023
A new Interagency Working Group for Bayh-Dole will review the government’s authority to revoke licenses for medical products.
March 23, 2023
The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.