Imviva Biotech announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to its lead program CTD402 for the treatment of relapsed…
January 27, 2026
January 27, 2026
Quoin Advances Global Regulatory Strategy with Japan Orphan Drug Submission for QRX003
Quoin Pharmaceuticals (Nasdaq: QNRX) announced that it has submitted an application to Japan’s Ministry of Health, Labour and Welfare (MHLW) for Orphan Drug Designation (ODD)…
Shares of Intellia Therapeutics (NASDAQ: NTLA) surged 20% after the U.S. Food and Drug Administration lifted a clinical hold on the company’s Phase 3 MAGNITUDE-2…
Several developments across large-cap pharma and emerging biotech this week are sharpening investor focus on commercial execution, pipeline optionality, and near-term regulatory catalysts — with…
ClearPoint Neuro (NASDAQ: CLPT) announced that its ClearPoint Navigation Software Version 3.0.2 has received EU Medical Device Regulation (MDR) certification, clearing the way for broader…
Sanofi (NASDAQ: SNY) makes plans to pursue regulatory approval for amlitelimab, its late-stage treatment for atopic dermatitis, despite mixed results from Phase 3 clinical trials….
January 23, 2026
Qure.ai & Gates Partner to Advance AI Lung Strategy
Qure.ai, a prominent developer of artificial intelligence for medical imaging, has officially secured a multimillion-dollar grant from the Bill & Melinda Gates Foundation. This strategic…
Alzheimer’s disease remains one of the most challenging areas in medicine, but a new wave of therapies is moving beyond traditional amyloid-only approaches. These next-generation…
The U.S. Food and Drug Administration has issued new draft guidance aimed at speeding the development and approval of treatments for multiple myeloma, a highly…
Laser Photonics (NASDAQ: LASE) announced a $1.3 million order from a new international pharmaceutical customer for its high-throughput tablet laser drilling system, marking another meaningful…
January 22, 2026
Lexicon Pharmaceuticals Secures FDA Alignment for LX9211
Lexicon Pharmaceuticals (NASDAQ: LXRX) recently announced a major regulatory milestone regarding its lead clinical candidate, LX9211. The company successfully completed an End-of-Phase 2 meeting with…
Kuva Labs, a cancer imaging and diagnostics company, has agreed to acquire Lisata Therapeutics (NASDAQ: LSTA), gaining full ownership of its Phase 2 solid tumor…