News

Pickles recall update as FDA issues risk warning

The recall has been given a Class II classification, indicating there is a significant level of risk posed to consumers in ...

Houston-based Empower Pharmacy’s drugs raised red flags for FDA and other states, but not Texas

Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.

FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

FDA chief has no 'plans' for abortion pill policy changes but continues safety review

Food and Drug Administration Commissioner Marty Makary said in a recent interview he has no plans to change policies regarding the abortion pill mifepristone.

FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

FDA Issues Bread Recall Update After Glass Discovered in Crusts

For consumers, the FDA and Upper Crust Bakery LP advised that bread with affected lot numbers should not be consumed but ...

9 Major Food Safety Issues From The 80s That Everyone Just Ignored

The '80s were a time of unique food products and diet trends, but these eyebrow-raising food safety issues just weren't top ...

Sarepta drops as report suggests FDA needs new trials for Elevidys

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

FDA flags safety concerns related to GSK’s blood cancer drug ahead of AdCom meeting

GSK (GSK) stock in focus as the FDA staff raise safety concerns over Blenrep combo for multiple myeloma ahead of an AdCom ...
Fierce Pharma7d

FDA advisors spurn GSK's Blenrep comeback dreams on safety, trial concerns

On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...
BioSpace58m

Sarepta’s Future Increasingly Uncertain as FDA Eyes New Study for Elevidys

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
The Business & Financial Times on MSN1d

Regulatory hurdles at FDA discourage SMEs, raising public safety concerns

By Kingsley Webora TANKEH Bureaucratic bottlenecks and high regulatory costs at the Food and Drugs Authority (FDA) are discouraging many small- and medium-sized enterprises (SMEs) from obtaining the ...