Fierce BiotechOpinion

‘A concerted industry-government effort’: Strand Therapeutics CEO Jake Becraft on FDA’s IND reform and China

For Jake Becraft, Ph.D., the future of America’s biomedical innovation isn’t just playing out in the lab—it's being shaped by ...

Telomir Pharmaceuticals Announces FDA Clearance of IND for Telomir-Zn in Triple-Negative Breast Cancer

Company Plans to Initiate First-in-Human Phase 1/2 Trial in 1H 2026, Anchored by a Leading U.S. Academic Medical ...
Morningstar

FDA Clears FluoGuide's IND for FG001 in High-Grade Glioma; U.S. Clinical Trial Remains on Track

COPENHAGEN, DENMARK / ACCESS Newswire / February 20, 2026 / FluoGuide A/S (STO:FLUO) ("FluoGuide" or the "Company"), a biotech company maximizing surgical outcomes in oncology by lighting up cancer, ...
Tallahassee Democrat

TriCelX Files IND with FDA & Concurrently Requests RMAT Designation for XytriX™ in the Treatment of Knee Osteoarthritis

IND Filing and Concurrent RMAT Request Position XytriX™ as a Potential Breakthrough Biotherapeutic for More Than 500 Million People Living with Osteoarthritis Our concurrent request for RMAT ...
Enid News & Eagle

Vistagen Receives FDA “Study May Proceed” Letter Under its Refisolone IND Application, Enabling Further Phase 2 Clinical Development for the Treatment of Vasomotor Symptoms ...

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product ...
RAPS

FDA Guidance Establishes When an IND May Not be Required to Conduct Human Studies

The US Food and Drug Administration (FDA) has released a new final guidance document intended to assist sponsors in determining whether a research study involving human subjects may be conducted ...
Healio

FDA accepts IND for allogeneic CAR T-cell therapy that could bypass lymphodepletion

Please provide your email address to receive an email when new articles are posted on . The FDA has accepted an investigational new drug application for ALLO-329, an allogeneic chimeric antigen ...