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BioSpace1d

After Court Win, Vanda Asks Makary To Review ‘Unacceptable’ Approval of Rival Generics

Vanda claims that two generics to its sleep disorder drug Hetlioz were approved despite inadequate data and is requesting ...
Spatula Desserts on MSN12h

FDA Proposes Orange Juice Rule Change to Boost American Citrus Industry

New FDA Rule Could Save Florida Orange Growers Millions Key Points Your morning glass of orange juice might taste exactly the ...
STAT1d

FDA says it will publish reports of adverse events tied to drugs on daily basis

The FDA said it has begun publishing reports of adverse events concerning drugs on a daily basis, instead of quarterly, as it ...

FDA’s new expert panels are rife with financial conflicts and fringe views

A series of panels convened by the Food and Drug Administration is raising concerns that the agency is skirting federal rules and promoting fringe views about antidepressants and other products ...
Slingshot News on MSN3d

'There Have Been A Couple': When Martin Makary Demonstrated His Incompetence, Admitted To Recklessly Firing Researchers At The FDA During Hearing

During his remarks in a Senate hearing in May, FDA Commissioner Marty Makary admitted to recklessly firing researchers at the Food and Drug Administration. Makary stated, "There have been a couple." ...

Drug Approvals Hit an FDA Wall

Therapies for rare and deadly disease are dying in Marty Makary’s shop.

FDA commissioner predicts ‘record’ drug approvals this year

Food and Drug Administration Commissioner Marty Makary said approving drugs for human consumption is moving at a "record" ...

FDA proposes way to cut sugar in orange juice without changing the taste

The FDA is proposing an update to a decades-old orange juice rule that could give American citrus growers a boost — with ...
Medscape5d

FDA Warns of Future Action on Animal-Derived Thyroid Drugs

US regulators sent seemingly mixed messages this month about the outlook for animal-derived, or desiccated, thyroid medicines ...
BioSpace3d

With Prasad Back at FDA, Capricor To Fight DMD Cardiomyopathy Rejection

Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the ...

FDA Head Marty Makary on Food Dyes, Ultra-Processed Foods and the MAHA Agenda

The Food and Drug Administration commissioner reveals what health officials are prioritizing in a forthcoming report on childhood chronic disease.

FDA Chief Says He Wants Gene Therapy Head Prasad to Return

US Food and Drug Administration Commissioner Marty Makary said he’s trying to persuade Vinay Prasad, the agency’s former head of gene therapy and vaccines, to return to the FDA after his abrupt ...