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The rollercoaster week for Sarepta Therapeutics continued, with shares of the embattled gene therapy-turned-siRNA biotech down 37% Friday afternoon as media outlets reported FDA plans to request a ...
The patient, who was being treated with an investigational gene therapy for limb-girdle muscular dystrophy, died of acute ...
In its Q2 earnings call Thursday, Novartis said it is moving quickly to reshore its drug manufacturing operations, but CEO ...
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug ...
Sarepta Therapeutics appears to have right-sized itself after laying off over a third of its staff, announcing a significant ...
Participants in trials of BrainStorm Cell Therapeutics' NurOwn filed a Citizens’ Petition with the FDA earlier this month ...
In the first 6 months of 2025, 385 employees resigned from the Center for Drug Evaluation and Research, compared with under ...
In advance of CMS’ negotiated price for the blood thinner taking effect next year, partners Bristol Myers Squibb and Pfizer ...
Despite the failure, BMS remains “encouraged” by Reblozyl’s clinical activity in myelofibrosis-associated anemia and will approach regulators to discuss potential submissions for this indication, for ...
Following the death of two teenage patients with Duchenne muscular dystrophy following Elevidys treatment, Sarepta ...
FDA reviewers flag "discordant results" in a briefing document published ahead of Friday's advisory committee meeting for the ...
Some of the most high-profile acquisitions in recent years have involved women-fronted biotechs. BioSpace reviews five of the ...
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