FDA

News

Is FDA about to restrict vaccination even further?

Vinay Prasad, head of CBER, is reported to be planning to tighten regulations on vaccines after concluding that COVID-19 shots caused 10 child deaths.

R&D

black lady smiling and looking at laptop

Working together to innovate on pragmatic clinical trials, w...

In today’s episode, host Jonah Comstock speaks with Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma.

News

FDA unveils swift route to market for personalised drugs

FDA reveals a regulatory pathway for personalised therapies based on 'plausible mechanism', drawing on the bespoke gene-editing treatment of Baby KJ.

News

FDA appoints veteran Pazdur to replace Tidmarsh

The FDA has steadied the ship at CDER by naming veteran regulator Richard Pazdur as director, although he was reportedly reluctant to take the job.

Market Access

Policy in Focus: Trump’s MFN deals, FDA vouchers, and the go...

Policy experts Alice Valder Curran and Elizabeth Jungman of Hogan Lovells weigh in on Trump's MFN deals, FDA vouchers, and the government shutdown.

News

GLP-1s feature in second batch of national priority vouchers

GLP-1 drugs for weight loss, cancer, and rare diseases feature among the latest crop of medicines awarded priority vouchers by the FDA.

Is FDA about to restrict vaccination even further?

Working together to innovate on pragmatic clinical trials, w...

FDA unveils swift route to market for personalised drugs

FDA appoints veteran Pazdur to replace Tidmarsh

Policy in Focus: Trump’s MFN deals, FDA vouchers, and the go...

GLP-1s feature in second batch of national priority vouchers

Repligen builds in cell therapy with $1.5bn BioLife takeover

Discover a new era of healthcare panel engagement: Grounded ...

FDA

Editor's Picks