Hansa Biosciences’ Idefirix (imlifidase) has reduced patients’ antibodies to a level that allows dosing in patients with ...

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

US Food and Drug Administration Commissioner Marty Makary said he’s trying to persuade Vinay Prasad, the agency’s former head of gene therapy and vaccines, to return to the FDA after his abrupt ...

Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy ...

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

Experienced commercial leader to shape launch strategy and global market readiness for telitacicept and future pipeline ...

During his first term, Trump signed the “Right to Try” law, which allows terminally ill patients to seek treatments that haven’t been fully approved by the FDA, the AP reported.

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 ...

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.

Investing.com -- US Food and Drug Administration Commissioner Marty Makary is attempting to convince Vinay Prasad, who recently left his position as head of gene therapy and vaccines, to return to the ...

Evidence-based medicine "Boy Wonder" Dr. Vinay Prasad was fired as CBER Director after less than three months on the job.

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