FDA Extends Review of Denali’s Hunter Syndrome Drug
Denali Therapeutics’ biologics license application for tividenofusp alfa, a brain-penetrant enzyme replacement for Hunter syndrome (MPS II), will undergo...
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Denali Therapeutics’ biologics license application for tividenofusp alfa, a brain-penetrant enzyme replacement for Hunter syndrome (MPS II), will undergo...
PMV Pharmaceuticals will present initial data from its pivotal Phase 2 PYNNACLE study of rezatapopt (PC14586), a first-in-class small...
Salarius Pharmaceuticals has regained compliance with Nasdaq’s equity standard, completing its return to full listing compliance after previously restoring...
Palisade Bio has secured a Canadian composition-of-matter patent for PALI-2108, a gut microbiota–activated, ileocolonic-targeted PDE4 B/D inhibitor in development...
Apyx Medical has submitted a new 510(k) to the FDA seeking a label expansion for its AYON body contouring...
Rentschler Biopharma is building a new buffer media station at its Laupheim, Germany headquarters, the largest single investment the...
Chapper Healthcare, now AscellaHealth’s global pharmaceutical wholesaler, distributor, and commercialization services arm, is marking its 50th anniversary with a...
Nilo Therapeutics has raised a $101 million Series A round and appointed industry veteran Kim Seth as CEO, signaling...
FDA has approved Regeneron’s PD-1 inhibitor Libtayo (cemiplimab-rwlc) as adjuvant therapy for adults with cutaneous squamous cell carcinoma (CSCC)...
InterCure reported first-half 2025 revenue of NIS 130 million, its eleventh straight period of positive adjusted EBITDA at 10%...
