A policy change allowing approval of some new drugs based on one adequate and well-controlled study could accelerate ...
In a NEJM article, Commissioner Martin Makary and top deputy Vinay Prasad argued that the new policy should lower development costs and speed development without compromising agency standards.
Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...
The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals.
July 2025 brought a flicker of hope for people with serious health needs: Congress exempted drugs with multiple orphan indications from the Inflation Reduction Act (IRA)’s Medicare Drug Price ...
Pharmaceutical Technology on MSN
MSD and Mayo Clinic team up to advance AI in drug development
MSD will integrate clinical insights and genomic datasets from Mayo Clinic Platform, aggregating data in a secure environment ...
Announcement reinforces SGS’s position as one of the few European CROs offering end-to-end human ADME programs This ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
Learn more about modern pharmaceuticals and how sometimes they are able to treat more than one type of illness.
The FDA has approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as the first and only subcutaneous, chemo-free ...
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