The FDA is allowing Sarepta to resume shipments of Elevidys (delandistrogene moxeparvovec) to ambulatory patients with Duchenne muscular dystrophy.

SRPT's Q2 report, set to arrive Aug. 6, is likely to have Elevidys updates, restructuring plans and sales outlook in sharp investor focus.

Swedish biotech Hansa Biopharma on Friday released encouraging top-line results from three patients with Duchenne muscular ...

Hansa Biosciences’ Idefirix (imlifidase) has reduced patients’ antibodies to a level that allows dosing in patients with Duchenne muscular dystrophy (DMD) with Sarepta and Roche’s Elevidys ...

After Loomer targeted surgeon general nominee and Kennedy ally Casey Means, Means’s brother, Calley, suggested that Loomer’s ...

The FDA's top vaccine official is stepping down after just 3 months in a role that upset drug companies, patient groups and some political leaders.

The cost of high-end, breakthrough medications traumatizes patients and their families. According to USAfacts, “national ...

Since becoming Vertex's top scientist in 2015, Altshuler has helped the company become an industry powerhouse. He’ll depart ...

Bulwark reporter Will Sommer reports MAGA influencer Laura Loomer is drawing criticism from MAGA members who claim she’s ...

President Trump's executive order to "identify and take appropriate action to correct past misconduct by the Federal Government related to censorship of protected speech" is good enough, DOJ tells ...

While the deaths occurred in patients who had been treated with Agios’ anemia treatment Pyrukynd, the biotech insisted in an ...

Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect ...