The potential approval of Vertex’s IgAN therapy povetacicept in 2026 comes amid launch headwinds for the company’s non-opioid ...

Sarepta nevertheless plans to push for full FDA approval of Vyondys 53 and Amondys 45 based on what it said are “encouraging ...

Kygevvi is indicated for patients with thymidine kinase 2 deficiency whose symptoms arise by 12 years of age. The disease ...

Pfizer has filed two separate lawsuits in an effort to stop Novo Nordisk's unsolicited bid to acquire obesity biotech Metsera ...

Less than 24 hours after resigning his post as the FDA’s head drug regulator, George Tidmarsh is reportedly reconsidering his decision and vowing to fight for his name and credibility amid a probe ...

Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for ...

Had Pfizer’s Freda Lewis-Hall not stepped in, SpringWorks' rare disease treatment may never have reached patients. Pharmas ...

Industry leaders say uncertainty in funding, clinical development and manufacturing is driving companies to embrace digital ...

Vinay Prasad, chief of the FDA’s Center for Biologics Evaluation and Research, is planning to publish a paper this month to ...

Manifold will use its tissue-targeting shuttle technology to help Roche develop new therapeutics for diseases of the central nervous system.

There are a number of considerations that can help streamline the pathway to the clinic. One of the first is which vector system will be used, with AAV and lentivirus being two of the most commonly ...

With a 100% response rate in a Phase II study, KYV-101 sets a new efficacy bar in generalized myasthenia gravis, according to ...