News

BioSpace1d
‘Unprecedented’ FDA Leaks Sow Confusion For Patients, Sarepta and Capricor
Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy ...
Townhall2dOpinion
What’s Happening to the ‘Right to Try’?
Exploring the impact and challenges of the 'Right to Try' legislation for experimental treatments.
FDA’s Reversal on Gene Therapy Helps My Son
Parents of boys with Duchenne muscular dystrophy weigh in on drug innovation and medical regulation.
Fierce Pharma3d
Untangling Sarepta’s gene therapy fallout and a growing trust deficit
Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...
BioWorld5d
In Broadway trial, a hopeful tune for Alzheimer’s prevention
At the 2025 Alzheimer’s Association International Conference, one of the bigger splashes was made by an experimental cardiovascular drug. Newamsterdam Pharma Co. NV presented data showing that its ...
Amazon S3 on MSN5d
The story of Sarepta's Duchenne gene therapy
The last couple of weeks has been particularly distressing for Duchenne muscular dystrophy patients and their families. The ...
Healio5d
Oncologist who served as FDA’s chief medical officer, top vaccine official departs agency
A controversial hematologist-oncologist who joined FDA this spring and quickly became its top regulator has left the ...
FDA’s top vaccine official Vinay Prasad resigns after Loomer campaign against him
Vinay Prasad recently drew outrage from conservatives, including Laura Loomer, who disagreed with his approach to approving ...
STAT5d
STAT breaks down the confusing, heartbreaking Sarepta saga
In the latest episode of STATus Report, Alex Hogan breaks down the confusing, heartbreaking saga of Sarepta and its gene ...
InnovationRx: Trump’s EU Tariff Deal Will Add $13 Billion To Drug Costs
In this week’s edition of InnovationRx, we look at Halle Berry’s menopause startup, Ambience Healthcare’s $243 million ...
The New York Sun5d
FDA’s Top Regulator Is Out Amid MAHA Backlash Over Blocking Access to a $3.2 Million Per Dose Therapy for Rare Disorder in Boys
Vinay Prasad, who came under fire from patient advocacy groups and Laura Loomer, is gone after less than three months on the ...
BioSpace5d
Exit Stage Right: With Prasad Out, Analysts Hope for More Traditional Replacement
As analysts parsed news of Vinay Prasad’s ouster, worries over drug approval delays, cell and gene therapy impacts and more ...