Swing Therapeutics has joined the ranks of digital therapeutics (DTx) developers with an FDA-approved product, after the regulator greenlit its Stanza app for people with
The FDA has approved Krystal Biotech’s gene therapy Vyjuvek for dystrophic epidermolysis bullosa (DEB), a rare genetic disease characterised by fragile skin that can split
Astellas has become the first drugmaker to bring a drug in the neurokinin 3 (NK3) receptor antagonist class to the US market, after getting FDA approval of fezolinetant fo
After much deliberation, the FDA has granted accelerated approval for Biogen’s tofersen for an ultra-rare form of the neurodegenerative disease amyotrophic lateral scleros
The FDA has set aside reservations it had about the use of Roche’s Polivy as a first-line treatment with chemotherapy for diffuse large B-cell lymphoma (DLBCL), and cleare
AbbVie has carved out a niche for its migraine drug Qulipta in a competitive market, after claiming FDA approval for the product in the prevention of chronic migraine.