The FDA has approved GSK’s MenABCWY vaccine—the first pentavalent conjugate capable of protecting against five key meningococcal serogroups—marking …
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 …
Daiichi Sankyo’s antibody–drug conjugate Datopotamab Deruxtecan secures U.S. approval, offering a new treatment for patients with previously treated …
With a PDUFA date set for June 2025, the copper histidinate therapy may soon become the first FDA-approved …
A landmark U.S. FDA nod for Datopotamab deruxtecan (Datroway) marks a promising advance for treating metastatic HR‑positive, HER2‑negative …
A pivotal agreement between uniQure and the FDA ignites momentum for Huntington’s gene therapy, while Europe’s regulatory landscape …
In a late-2024 milestone, the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for Mesoblast’s stromal cell therapy injects …
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