Regulatory & Policy
TransThera wins first China approval in post-FGFR cholangiocarcinoma
China's National Medical Products Administration (NMPA) has granted conditional marketing approval to Yochanra (tinengotinib) tablets for adult patients...
Takeda ushers in the orexin era with landmark FDA approval
The US FDA has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1) in adults, marking the first approval of an orexin receptor...
Lexeo's PKP2 cardiomyopathy gene therapy adds RMAT status
New York-based Lexeo Therapeutics (Nasdaq: LXEO) announced that the US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to LX2020,...
Moderna's mFlusiva becomes first mRNA influenza vaccine in US
The US FDA has approved Mflusiva (mRNA-1010), Cambridge, Massachusetts-based Moderna's (Nasdaq: MRNA) mRNA-based seasonal influenza vaccine, for active...
Arrowhead nabs FDA priority review voucher for plozasiran
Pasadena, California-based Arrowhead Pharmaceuticals (Nasdaq: ARWR) announced that it has signed an agreement to acquire a US FDA Rare Pediatric Disease...
XellSmart's off-the-shelf Parkinson's cell therapy gets FDA fast-track treatment
China-based XellSmart Biopharmaceutical Co., Ltd. announced on July 28, 2026 that the US FDA has granted Fast Track Designation (FTD) to XS411, an...
FDA approves Pluvicto in earlier-stage prostate cancer, expanding Novartis's radioligand franchise
The US FDA has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for patients with...
Zai Lab's zoci takes FDA orphan drug designation for neuroendocrine carcinomas
Zai Lab (Nasdaq: ZLAB) announced receipt of US FDA orphan drug designation for zocilurtatug pelitecan (zoci, formerly ZL-1310), its delta-like ligand 3...
China grants breakthrough status for InnoCare's orelabrutinib-mesutoclax combo in MZL
China-based InnoCare Pharma (HKEX: 09969; SSE: 688428) announced that the orelabrutinib mesutoclax combination has been granted Breakthrough Therapy...
Aravax secures FDA Fast Track designation for PVX108 peanut allergy immunotherapy
Aravax, a clinical-stage biotechnology company headquartered in Melbourne, Australia and Oxford, UK, announced receipt of US FDA Fast Track Designation for...
Lilly's olomorasib earns FDA Breakthrough Therapy designation for KRAS G12C pancreatic cancer
Eli Lilly and Company (NYSE: LLY) announced on August 3, 2026 that the US FDA has granted Breakthrough Therapy Designation (BTD) to olomorasib (LY3537982),...
China clears Insilico's BBB-penetrant NLRP3 inhibitor for Parkinson's Phase I study
Insilico Medicine (HKEX: 03696) announced on August 3, 2026 that ISM8969/HT-001, an orally available, blood-brain barrier (BBB)-penetrant NLRP3 inhibitor...
Hengrui wins China approval for first domestically developed basal insulin analog
China's National Medical Products Administration (NMPA) has approved insulin sudelidec injection — marketed by Jiangsu Hengrui Pharmaceuticals (HKEX: 01276)...
Replimune overcomes skeptical FDA briefing as panel backs RP1 in 10-3 vote
With an FDA decision just two days away, Woburn, Massachusetts-based Replimune Group (Nasdaq: REPL) received a broadly favorable signal from an advisory...
Insilico's AI-designed TEAD inhibitor secures FDA fast track for mesothelioma
Cambridge, Massachusetts-based Insilico Medicine (HKEX: 3696) announced receipt of US FDA Fast Track Designation (FTD) for ISM6331, a small-molecule...
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