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June 11, 2026 08:03 ET | Source: Sixty Degrees Pharmaceuticals

60 Degrees Pharmaceuticals Signs Exclusive Patent License Agreement with Florida State University for Non-Prescription Use of Australian Chestnut Extract as a Botanical Supplement

60 Degrees Pharma licensed FSU technology for Australian Chestnut Extract production and plans FDA discussions before refiling its NDIN.
June 09, 2026 11:37 ET | Source: FDA

FDA Expands Sunscreen Options for the First Time in 20 Years

Silver Spring, Md., June 09, 2026 (GLOBE NEWSWIRE) -- Today, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant...
June 09, 2026 09:54 ET | Source: Equity Insider

A Fresh FDA Catalyst Is Putting Regenerative Wound Care in Focus

NEW YORK, June 09, 2026 (GLOBE NEWSWIRE) -- Equity Insider News Commentary — In healthcare, the market tends to perk up when a company stops speaking in broad platform language and starts showing...
June 09, 2026 08:00 ET | Source: Matisse Pharmaceuticals

Matisse Pharmaceuticals receives FDA Fast Track Designation for isupartob sodium in sepsis

Matisse obtains FDA Fast Track Designation for isupartob sodium in sepsis. FDA's Fast Track is designed to get important new drugs to the patient earlier.
June 08, 2026 07:00 ET | Source: Amphista Therapeutics

Amphista Therapeutics announces FDA clearance of IND application for AMX-883, its lead Targeted Glue™ degrader for acute myeloid leukaemia

Amphista to initiate its first clinical trial for AMX-883, a potent, orally bioavailable DCAF16-dependent degrader of BRD9, for acute myeloid leukaemia (AML) in H2 2026The Phase 1 monotherapy...
June 08, 2026 02:00 ET | Source: Amphista Therapeutics

Amphista Therapeutics announces FDA clearance of IND application for AMX-883, its lead Targeted Glue™ degrader for acute myeloid leukaemia

Amphista to initiate its first clinical trial for AMX-883, a potent, orally bioavailable DCAF16-dependent degrader of BRD9, for acute myeloid leukaemia (AML) in H2 2026The Phase 1 monotherapy...
June 05, 2026 08:30 ET | Source: Vivos Inc.

Vivos Inc. (OTCQB: RDGL) submits Early Feasibility Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for RadioGel® Precision Radionuclide Therapy™

Kennewick, WA, June 05, 2026 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), a company pioneering Precision Radionuclide Therapy™ (PRnT) with its innovative RadioGel® technology, today announced the...
June 03, 2026 09:45 ET | Source: MAIA Biotechnology, Inc.

MAIA Biotechnology Receives FDA Clearance to Open U.S. Enrollment in Ongoing Phase 2 THIO-101 Trial Expansion

Additional data from THIO-101 trial expansion studies may further support a potential Accelerated Approval filing with FDA FDA-cleared IND updates detail latest efficacy data and enriched...
June 02, 2026 07:02 ET | Source: Pasithea

Pasithea Therapeutics Announces Orphan Drug Designation by FDA of PAS-004 for Treatment of Amyotrophic Lateral Sclerosis (ALS)

Pasithea Therapeutics Announces Orphan Drug Designation by FDA of PAS-004 for Treatment of Amyotrophic Lateral Sclerosis (ALS)
May 29, 2026 13:47 ET | Source: FDA

FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs

Silver Spring, Md., May 29, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for...