Investigational New Drug (original) (raw)

Latest News for: investigational new drug

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Atavistik Bio Announces U.S. FDA Clearance of Investigational New Drug Application and Fast Track Designation ...

Nasdaq Globe Newswire 09 Jun 2026

Atavistik Bio announces U.S. FDA clearance of investigational new drug application and Fast Track Designation for ATV-601 for the treatment of HHT ... .

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Imviva Biotech Receives FDA Investigational New Drug Approval for CTA313, a Dual-Targeted CD19/BCMA Allogeneic CAR-T ...

Nasdaq Globe Newswire 09 Jun 2026

Approval paves the way for CTA313 clinical study in the United States ...

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Atavistik Bio Announces U.S. FDA Clearance of Investigational New Drug Application and Fast

Hastings Tribune 09 Jun 2026

FDA cleared the Harmony-HHT Phase 1/2 study design, enabling Atavistik Bio to leverage existing clinical data with ATV-1601 and advance directly into a randomized study with individuals who have moderate to severe HHT ... .

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Enveric Biosciences Initiates Investigational New Drug (IND)-enabling Genotoxicity Studies of Lead Neuroplastogen Candidate EB-003

Hastings Tribune 02 Jun 2026

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun 2, 2026-- ... .

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Iovance Biotherapeutics Announces Clearance of Investigational New Drug (IND) Application for IL-12 Tethered TIL Therapy IOV-5001

Nasdaq Globe Newswire 01 Jun 2026

Next-Generation Platform Expands into Solid Tumors�. Representing 100,000+ U.S. Deaths Annually ... .

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Iovance Biotherapeutics Announces Clearance of Investigational New Drug (IND) Application for

The Eagle-Tribune 01 Jun 2026

Next-Generation Platform Expands into Solid Tumors ... .

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ReST Therapeutics Announces U.S. FDA Acceptance of Investigational New Drug (IND) Application for RST-101 for ...

Business Wire 29 May 2026

Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) ...

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Kelun-Biotech Receives Investigational New Drug Approval from CDE for SKB118, a PD-1 x VEGF Bispecific Antibody

Floyd County Chronicle 13 May 2026

("Kelun-Biotech" or the "Company", 6990.HK) announced that ...

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Chengdu Origen and Vanotech Announce KHN921 Investigational New Drug application clearance by the US FDA ...

Nasdaq Globe Newswire 13 May 2026

Investigational New Drug application for KHN921 received “study may proceed” from the US FDA ... Investigational ...

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Cellenkos Announces FDA Clearance of Investigational New Drug (IND) Application for Phase 1b/ 2a Trial of CK0802 in Steroid-Refractory Graft-versus-Host Disease (GVHD)

PR Newswire 04 May 2026

Food and Drug Administration (FDA) has cleared its Investigational New Drug application to initiate a Phase 1b/ 2a clinical trial of CK0802 for the treatment of patients with steroid-refractory graft-versus-host disease (GVHD).

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Cellenkos Announces FDA Clearance of Investigational New Drug (IND) Application for Phase 1b/ 2a Trial ...

Canada Newswire 04 May 2026

Food and Drug Administration (FDA) has cleared its Investigational New Drug application to initiate a Phase 1b/ 2a clinical trial of CK0802 for the treatment of patients with steroid-refractory graft-versus-host disease (GVHD).

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BRC Therapeutics Announces Investigational New Drug Application for BRC-002 Cleared by FDA

Missoulian 29 Apr 2026

Clearance will accelerate development of a therapeutic for Complex Regional Pain Syndrome (CRPS) ... .

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LayerBio Announces FDA Acceptance of Investigational New Drug (IND) Application for OcuRing-K, a Sustained-Release Ketorolac ...

ACCESSWIRE 28 Apr 2026

Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for OcuRing-K™, an intraocular implant designed to deliver therapeutic levels of ketorolac directly within the eye following cataract surgery.

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Dogwood Therapeutics Announces FDA Acceptance of SP16 Investigational New Drug Application for the Treatment of ...

Nasdaq Globe Newswire 15 Apr 2026

Dogwood�licensed SP16 to treat cancer-related pain from partner and regulatory sponsor Serpin Pharma ... .

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Dogwood Therapeutics Announces FDA Acceptance of SP16 Investigational New Drug Application for

Hastings Tribune 15 Apr 2026

Dogwood licensed SP16 to treat cancer-related pain from partner and regulatory sponsor Serpin Pharma ... .