Clene Advances CNM-Au8 Toward ALS Accelerated Approval
SALT LAKE CITY, Utah, August 10, 2026 Clene Inc. announced new biomarker analyses for CNM-Au8 that will be included...
Accelerated Approval
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Nicox Files NCX 470 NDA in China Through Ocumension
Sophia Antipolis, France, August 10, 2026 Nicox SA announced that its exclusive Chinese licensee Ocumension Therapeutics has submitted a...
Innate Pharma to Advance Lacutamab Toward Phase 3 with Sobi
MARSEILLE, France, August 10, 2026 Innate Pharma SA announced plans to initiate the TELLOMAK-3 confirmatory Phase 3 study of...
FDA Approves Tudriqev for Advanced Refractory Melanoma
Silver Spring, Maryland, USA, August 8, 2026 The U.S. Food and Drug Administration (FDA) has granted accelerated approval to...
Karyopharm Eyes Accelerated FDA Approval for Selinexor
NEWTON, Mass., July 30, 2026 Karyopharm Therapeutics Inc. plans to submit a supplemental New Drug Application (sNDA) to the...
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OS Therapies Advances OST-HER2 Toward FDA Approval
NEW YORK, March 31, 2026 — OS Therapies, Inc a clinical-stage oncology company specializing in listeria-based cancer immunotherapies, has...
OS Therapies Advances OST-HER2 Toward Phase 3 Trial
New York, March 27, 2026 OS Therapies has achieved a significant regulatory milestone by securing meetings with multiple global...
FDA Grants Priority Approval to Hernexeos for NSCLC
WASHINGTON, D.C., February 26, 2026 The U.S. Food and Drug Administration (FDA) has granted approval to Hernexeos (zongertinib) for...
OST-HER2 Regulatory Progress Advances Osteosarcoma Care
NEW YORK, NEW YORK, UNITED STATES — February 17, 2026 OS Therapies has announced a major global regulatory update...
FDA CRL Delays Bitopertin Approval for Rare EPP Disease
WATERTOWN, Mass., Feb. 13, 2026 — Disc Medicine announced that the U.S. Food and Drug Administration has issued a...
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