The European Commission has approved Roche’s Susvimo implant for neovascular age-related macular degeneration, offering continuous ranibizumab delivery with refills every six months and creating a fundamentally different alternative to repeated eye injections.
XORTX Therapeutics shares climbed 15.7% as trading volume surged above seven million shares after the company outlined plans to file an FDA IND for XRx-026 in the fourth quarter, but funding requirements remain a critical part of the development story.
Japan has approved the Leqembi Pen for once-weekly at-home administration in early Alzheimer’s disease, potentially reducing infusion-center dependence while giving Biogen and Eisai another way to differentiate lecanemab from rival anti-amyloid therapies.
Aquestive Therapeutics has resubmitted its Anaphylm application after responding to FDA concerns over packaging and administration, putting the potential needle-free, orally delivered emergency treatment for anaphylaxis back on a regulatory path toward the U.S. market.
European regulators have backed Tecvayli monotherapy after only one prior multiple myeloma treatment, potentially transforming Johnson & Johnson’s BCMA bispecific from a late-line therapy into a much larger second-line franchise.
Longeveron shares have lost nearly two-thirds of their value in two sessions after laromestrocel failed the primary endpoint in the ELPIS II study for hypoplastic left heart syndrome, forcing the biotechnology company to reassess its development strategy, conserve cash and review options to maximize shareholder value.
European regulators have backed once-weekly Sogroya for children with idiopathic short stature, potentially giving Novo Nordisk the first EU-approved growth hormone specifically for the condition while expanding a rare-endocrine franchise beyond growth hormone deficiency.
Xenon Pharmaceuticals shares suffered their biggest recent sell-off after the company paused new enrollment in late-stage depression studies over neuropsychiatric adverse events, overshadowing an important FDA filing for azetukalner in focal seizures.
Bristol Myers Squibb and Ono Pharmaceutical are suing Amgen over seven patents tied to its proposed Opdivo biosimilar ABP 206, opening an important legal battle around a cancer drug that generated more than $10 billion in 2025.
Ultragenyx Pharmaceutical has secured full FDA approval for Fayuvi, the first treatment for Sanfilippo syndrome Type A, giving the rare-disease biotech a major commercial catalyst only weeks after a Phase 3 setback erased nearly half its market value.