FDA: Novo Nordisk failed to report deaths of weight-loss drug patients

Novo Nordisk's reports to the FDA spiked shortly after an inspection found the Ozempic producer ignored reports of deaths and potential side effects.

NRx Pharmaceuticals (Nasdaq:NRXP) Announces FDA Bioequivalence Determination by Office of Generic Drugs for NRx’s Preservative-Free Ketamine Application

Determination of bioequivalence to the Reference Listed Drug is essential for approval of an Abbreviated New Drug Application (ANDA).FDA has ...

FDA finds little evidence that a drug touted by Trump can help people with autism

The Food and Drug Administation is approving a generic drug for a very rare genetic disorder, but not for autism.

FDA approves generic drug for a rare genetic condition, but not for autism

Dr. Marty Makary, the FDA’s commissioner, said in a statement that the “approval represents a significant milestone for ...
Yahoo

FDA recall of blood pressure pills due to cancer-causing contaminant may point to higher safety risks in older generic drugs

Add Yahoo as a preferred source to see more of our stories on Google. Nitrosamines are by-products of many common chemical reactions. FatCamera/iStock via Getty Images Plus A generic blood pressure ...

FDA proposes to ease testing rules to speed up biosimilar drug development

March 9 (Reuters) - The U.S. health regulator issued a draft guidance on Monday to help drugmakers develop cheaper versions of complex biologic medicines, aiming to lower the cost of treatments for ...
FiercePharma

2025 approvals: Biopharma delivered 55 new drugs, biologics

While it would be presumptuous to base conclusions solely on the number of drugs the FDA approved in 2025, it is noteworthy that FDA nods of new treatments fell short of previous years, though a surge ...
The Hill

FDA to streamline approvals of generic biologic drugs

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...

FDA finds little evidence that a generic drug could help many people with autism

The Food and Drug Administration on Tuesday approved a generic medication for a rare brain disorder, while walking back suggestions by President Donald Trump and other administration officials ...
CNN

FDA’s top drug officer set to exit, weeks into new role

The US Food and Drug Administration’s longtime oncology chief has filed to retire from the agency just weeks after he was chosen to lead the FDA’s drug division, according to four people familiar with ...
Fox Business

Hims & Hers responds to FDA pressure, pulls knockoff Wegovy drug launch after regulatory threats

Following threats from the Food and Drug Administration (FDA) that it would take "decisive" action against companies selling "illegal copycat drugs," telehealth company Hims & Hers announced it would ...
ProPublica

The FDA Often Doesn’t Test Generic Drugs for Quality Concerns, So ProPublica Did

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. These highlights were written by the reporters and editors ...