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WebFDA Psychedelic Drug Therapy Standards Hearing 2026
1+ hour, 2+ min ago (139+ words) CONFERENCE COVERAGE | Considerations for Potential Future Therapeutic Use of Psychedelic Drugs FDA Public Hearing FDA received more than 200 speaker requests by the August deadline, more than double the available slots. Speakers were randomly selected with attention to topic coverage and…...
Compass Pathways Just Answered the Durability Question. Now Comes the Harder Problem.
3+ hour, 29+ min ago (872+ words) The Clinical Trial Vanguard Compass Pathways Just Answered the Durability Question. Now Comes the Harder Problem. The numbers from Part C of COMP005, covering weeks 26 through 52 in 258 patients with treatment-resistant depression, are worth sitting with. Participants from the 25mg COMP360 arm who received…...
Sionna to Test SION-451 and SION-2222 Combo in CF Phase 2a Trial
8+ hour, 56+ min ago (342+ words) The Clinical Trial Vanguard Sionna to Test SION-451 and SION-2222 Combo in CF Phase 2a Trial Sionna Therapeutics is betting that two correctors working on different parts of the CFTR protein will accomplish what one cannot: meaningful sweat chloride reduction in…...
The FDA Just Handed Psychedelic Drug Sponsors a Framework. Now the Hard Part Starts.
7+ hour, 59+ min ago (744+ words) The Clinical Trial Vanguard The FDA Just Handed Psychedelic Drug Sponsors a Framework. Now the Hard Part Starts. Three sponsors with active psychedelic INDs opened their inboxes on July 14, 2026, and found the same document: the FDA’s finalized guidance, “Psychedelic Drugs:…...
Biohaven Advanced BHV-7000 to Pivotal Trials Without Answering a Question the FDA Requires Every Sponsor to Answer
7+ hour, 57+ min ago (672+ words) The Clinical Trial Vanguard Biohaven Advanced BHV-7000 to Pivotal Trials Without Answering a Question the FDA Requires Every Sponsor to Answer On September 4, 2026, the FDA sent Biohaven a letter that stopped new patient enrollment in every BHV-7000 epilepsy study. The…...
Ivonescimab beats pembrolizumab on survival in first-line PD-L1-positive NSCLC
8+ hour, 58+ min ago (395+ words) The Clinical Trial Vanguard Ivonescimab beats pembrolizumab on survival in first-line PD-L1-positive NSCLC Three years after the first patient enrolled in HARMONi-2, ivonescimab has done something pembrolizumab monotherapy has not been beaten at in a randomized Phase III head-to-head…...
Researchers Misread IRB Review Pathways, Delaying Study Startups
8+ hour, 47+ min ago (420+ words) clinicaltrialvanguard.com Researchers Misread IRB Review Pathways, Delaying Study Startups Researchers routinely misread the four IRB review pathways, and that misreading costs them time. The gap between what sponsors assume and what regulators require shows up most clearly in processing…...
YPrime Guide: Supply Management Critical to IRT Trial Success for Biotech Sponsors
8+ hour, 46+ min ago (366+ words) clinicaltrialvanguard.com YPrime Guide: Supply Management Critical to IRT Trial Success for Biotech Sponsors Supply management, not randomization, is where IRT systems win or lose a trial budget. That framing sits at the center of a new operational guide from…...
Definium’s DT120 ODT Meets Primary Endpoint in Phase 3 GAD Study
8+ hour, 54+ min ago (321+ words) clinicaltrialvanguard.com Definium’s DT120 ODT Meets Primary Endpoint in Phase 3 GAD Study Definium Therapeutics reported positive topline data from its Phase 3 Panorama study of DT120 ODT in generalized anxiety disorder on September 14, 2026, a result that matters because GAD pharmacotherapy has run on…...
Rybrevant’s Second Act: How J&J Is Rewriting the Rules for EGFR-Mutant Lung Cancer
20+ hour, 52+ min ago (338+ words) From exon 20 insertions to subcutaneous delivery and inclusive trial design, Joshua Bauml explains why the biology demanded a different approach, and why first-line tolerability is now an efficacy argument. Joshua Bauml: We know that crossover has a substantial impact on…...