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March 10, 2026 07:30 ET | Source: Piston Bio

Piston Bio Announces FDA Alignment on PST-101 Development Program for Cancer-Related Apathy

MORRISTOWN, N.J., March 10, 2026 (GLOBE NEWSWIRE) -- Piston Bio LLC, a clinical-stage biotechnology company developing therapeutics targeting neuroimmune mechanisms in cancer, today announced the...
March 10, 2026 07:30 ET | Source: PMGC Holdings Inc.

NorthStrive Biosciences Announces Launch of EL-32 Preclinical Study Evaluating Muscle Preservation in GLP-1 Weight Loss Therapy

Northstrive Biosciences Announces Launch of EL-32 Preclinical Study Evaluating Muscle Preservation in GLP-1 Weight Loss Therapy
March 09, 2026 08:05 ET | Source: Sangamo Therapeutics, Inc.

Sangamo Therapeutics Advances Rolling Submission of BLA to U.S. FDA for ST-920 in Fabry Disease

Sangamo has now submitted the ST-920 preclinical and clinical modules to the FDA for review.
March 03, 2026 07:00 ET | Source: AtaiBeckley N.V.

AtaiBeckley Announces Successful End-of-Phase 2 Meeting for BPL-003 in Treatment-Resistant Depression

Aligned with FDA on dual-trial design Phase 3 program that aims to demonstrate robust efficacy and long-term safety and that allows for flexible dosingPhase 3 program initiation remains on track for...
March 02, 2026 08:30 ET | Source: Lantheus Holdings, Inc.

Lantheus Receives FDA Tentative Approval for Lutetium Lu 177 Dotatate (PNT2003), Radioequivalent to LUTATHERA®

BEDFORD, Mass., March 02, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus” or the “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling...
February 26, 2026 13:50 ET | Source: Boehringer Ingelheim Limited

FDA approves HERNEXEOS®, the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option

This press release is not intended for UK media HERNEXEOS® (zongertinib tablets) approved based on an objective response rate of 76% (N=72) as demonstrated in the Beamion LUNG-1 clinical trial1...
February 25, 2026 09:05 ET | Source: Totaligent

Totaligent Executes Binding LOI for Joint Venture and Acquisition of GloMed Solutions

Totaligent (OTCID: TGNT) signed a binding LOI with GloMed Solutions, a Japanese medical aesthetics and biologics distribution company
February 24, 2026 10:00 ET | Source: Siren Biotechnology, Inc.

Siren Biotechnology Receives FDA Fast Track Designation for SRN-101 for the Treatment of Recurrent High-Grade Glioma

Siren Biotechnology Receives FDA Fast Track Designation for SRN-101 for the Treatment of Recurrent High-Grade Glioma
February 23, 2026 08:00 ET | Source: Artios Pharma

Artios Receives U.S. FDA Fast Track Designation for DNA Polymerase Theta (Polθ) Inhibitor ART6043 for Treatment of gBRCA-mutated HER2-Negative Breast Cancer

Artios receives FDA Fast Track designation for DNA polymerase theta (Polθ) inhibitor ART6043 for treatment of gBRCA-mutated HER2-negative breast cancer
February 20, 2026 14:43 ET | Source: Teva Pharmaceutical Industries Ltd

U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in Adults

Olanzapine long-acting injectable (LAI) suspension (TEV-'749) has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation1If approved, TEV-'749 could help address...