China’s Center for Drug Evaluation (CDE) has accepted Nanjing Leads Biolabs’ New Drug Application for opamtistomig (LBL-024), a PD-L1 x 4-1BB bispecific antibody, and granted it Priority Review for extrapulmonary neuroendocrine carcinoma (EP-NEC), an…
The European Commission has expanded the approval of Johnson & Johnson’s teclistamab (Tecvayli), a BCMA-targeted bispecific antibody, in combination with daratumumab, to patients with relapsed or refractory multiple myeloma who have received at least…
The FDA approved Regeneron’s Pasatru (garetosmab-grts) to reduce new heterotopic ossification lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). The fully human Activin A-neutralizing antibody is the second approved medicine for…
The FDA granted accelerated approval to Ultragenyx’s Genglycos (pariglasgene brecaparvovec-opnr; DTX401), the first approved treatment for glycogen storage disease type Ia (GSDIa) and the company’s first approved gene therapy. The one-time intravenous AAV8 therapy…
Merck and Moderna reported that the randomized Phase III INTerpath-001 trial met its primary recurrence-free-survival (RFS) endpoint and key secondary distant-metastasis-free-survival (DMFS) endpoint at a prespecified interim analysis. The study compares individualized neoantigen therapy…
Amylyx reported that avexitide met the FDA-agreed primary endpoint in the 78-participant Phase III LUCIDITY trial for post-bariatric hypoglycemia following Roux-en-Y gastric bypass. Once-daily subcutaneous avexitide reduced the composite rate of Level 2 and…
AstraZeneca disclosed three divergent Phase III lung-cancer outcomes on the same day. In SAFFRON, osimertinib plus savolitinib met progression-free-survival and overall-survival endpoints versus platinum chemotherapy after osimertinib progression in biomarker-selected EGFR-mutant, MET-driven non-small cell…
The FDA granted accelerated approval to Bristol Myers Squibb’s iberdomide (Zenbexus), the company’s first approved CELMoD, in combination with daratumumab and hyaluronidase-fihj and dexamethasone, for multiple myeloma patients who have received at least one…
The European Medicines Agency published its scientific reasoning for revoking the European marketing authorization of Amgen’s avacopan (Tavneos), citing serious breaches of clinical trial conduct in the drug’s pivotal study—including unblinded access to efficacy…
Shattuck Labs reported Phase 1 healthy-volunteer results for SL-325, a monoclonal antibody that blocks the TL1A receptor DR3. The company observed 3.7% anti-drug-antibody incidence and complete blockade of TL1A binding to DR3 for more…
