Precision BioSciences receives IND clearance to launch US-based trial of PBGENE-HBV, a meganuclease gene-editing candidate for a functional …
Precision BioSciences receives IND clearance to launch US-based trial of PBGENE-HBV, a meganuclease gene-editing candidate for a functional …
European regulatory reforms are accelerating approvals for novel rare disease treatments, attracting global investment and expanding patient access.
The FDA has approved Merilog (insulin-aspart-szjj), marking the first biosimilar to Novolog (insulin aspart), and widening affordable insulin …
The FDA has cleared vimseltinib (Romvimza), a first-in-class CSF1R inhibitor, for symptomatic tenosynovial giant cell tumor—marking a breakthrough …
The FDA has approved SPN-830 (Onapgo)—a novel subcutaneous apomorphine infusion device—offering continuous, effective management of motor fluctuations in …
The FDA has approved GSK’s MenABCWY vaccine—the first pentavalent conjugate capable of protecting against five key meningococcal serogroups—marking …
A pioneering personalized cancer vaccine, designed using tumor-specific neoantigens, has achieved remission in all nine advanced kidney cancer …
On February 1, 2025, the U.S. Food and Drug Administration (FDA) approved Eli Lilly’s lebrikizumab, marking the first …
Vertex Pharmaceuticals earns approval for JOURNAVX™ (suzetrigine), a ground-breaking oral NaV1.8 pain channel inhibitor designed to target moderate-to-severe …
Arrowhead Pharmaceuticals’ NDA for plozasiran in rare, life-threatening FCS wins FDA acceptance, setting a PDUFA action date and …
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