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Medical start-ups must address the evolving risks of the FDA...

Embarking on the journey of a medical start-up is like navigating a complex labyrinth, where the final prize is the coveted FDA approval.

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FDA issues summary of grants, promotes rare disease research

The US Food and Drug Administration (FDA) has provided an ‘at-a-glance’ summary of the agency’s news.

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Vanda slams FDA rejection of gastroparesis drug

The FDA has declined to approve Vanda Pharma's tradipitant for delayed gastric emptying (gastroparesis), prompting a furious response from the company.

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AbbVie faulted for misleading ad featuring Serena Williams

Pharma giant AbbVie has been taken to task by the FDA for running an ad for one of its migraine drugs, featuring tennis star Serena Williams, which the agency says overstates its efficacy.<

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PBC drug choices rise in US with OK for Gilead's seladelpar

At the start of the year, there had been no new therapies for rare cholestatic liver disease primary biliary cholangitis (PBC) in the US for almost a decade.

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Article retractions muddy MDMA waters after FDA denial

The journal Psychopharmacology has retracted three articles about MDMA-assisted psychotherapy, shortly after the FDA rejected approval of Lykos Therapeutics' therapy for post-traumatic stre

Medical start-ups must address the evolving risks of the FDA...

FDA issues summary of grants, promotes rare disease research

Vanda slams FDA rejection of gastroparesis drug

AbbVie faulted for misleading ad featuring Serena Williams

PBC drug choices rise in US with OK for Gilead's seladelpar

Article retractions muddy MDMA waters after FDA denial

CDC panel votes to scrap hepatitis B birth dose advice

How to meet your physicians where they are online

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