BioSpace

Makary Defends FDA’s Decision-Making Amid Contentious Rare Disease Rejections

Without naming a specific product, Commissioner Marty Makary referred to an investigational therapy, delivered surgically ...

FDA watchers warn of 'chaos' inside agency, as regulatory delays, staff hemorrhaging risk America's health

Scientific, political pressures colliding at FDA, delaying rare disease treatment for patients who have few or no options, experts said at CNBC Cures Summit.

FDA will drop two-study requirement for new drug approvals, aiming to speed access

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals ...
Fierce Pharma

J&J's Tecvayli-Darzalex multiple myeloma combo takes home FDA's 3rd national priority nod

Johnson & Johnson’s standout trial results for its Tecvayli and Darzalex Faspro pairing in previously treated relapsed or ...

FDA Commissioner Dr. Makary on rare disease therapy approvals, internal politics at the agency

FDA Commissioner Dr. Marty Makary joins 'Squawk Box' to discuss the agency's efforts to accelerate the development of ...
Asianet Newsable on MSN

IBRX founder’s ‘congrats’ to GSK sparks debate after FDA fast drug approvals — retail slams big pharma bias over Anktiva

Investors are focused on Anktiva’s next regulatory step, as ImmunityBio seeks to expand the therapy to BCG-unresponsive ...
STATOpinion

The FDA, urged to avoid controversy, creates a new headache with attack against UniQure

Recent decisions at the FDA threaten to turn its disagreements with the drugmaker UniQure into another political headache for ...

FDA reversals leave investors worrying about the fates of other experimental drugs

Investors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S. Food and Drug Administration.