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February 24, 2026 10:00 ET | Source: RxLogic

RxLogic Affirms Commitment to Compliance and Transparency as PBM Regulatory Expectations Expand

RxLogic Affirms Commitment to Compliance and Transparency as PBM Regulatory Expectations Expand
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
December 23, 2025 19:45 ET | Source: Agios Pharmaceuticals, Inc.

U.S. FDA Approves Agios’ AQVESME™ (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia

Agios today announced that the U.S. FDA has approved AQVESME™ (mitapivat), an oral pyruvate kinase (PK) activator, for thalassemia
December 08, 2025 07:00 ET | Source: Agios Pharmaceuticals, Inc.

Agios Provides Update on U.S. sNDA for Mitapivat in Thalassemia

Agios today announced that the U.S. Food and Drug Administration (FDA) has not yet issued a regulatory decision on the sNDA for mitapivat in thalassemia
December 03, 2025 01:57 ET | Source: EBC Financial Group

EBC Financial Group Enters South Africa, Advancing Strategic Expansion in Africa

EBC Financial Group announces regulatory approval of its South African subsidiary, positioning the firm for future access to the country’s financial sector
October 17, 2025 08:00 ET | Source: Agios Pharmaceuticals, Inc.

Agios’ PYRUKYND® (mitapivat) Receives Positive CHMP Opinion for Adults with Thalassemia

Agios today announced that the CHMP has adopted a positive opinion for the new indication for PYRUKYND in adults for anemia associated with thalassemia
October 02, 2025 07:00 ET | Source: Draig Therapeutics

Draig Therapeutics Announces US FDA Clearance of IND Application for Phase 2 Study of DT-101 for the Treatment of Major Depressive Disorder

DT-101 is designed to allow effective modulation of the AMPA receptor without compromising safetyPhase 2 clinical trial initiation anticipated before the end of 2025Trial builds on positive Phase 1...
September 17, 2025 02:00 ET | Source: Opterion Health AG

Opterion Health AG submits Clinical Trial Application for First-in-Human Study of OPT101 in Patients with Advanced Chronic Kidney Disease

MUTTENZ, Switzerland, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Opterion Health AG, a clinical-stage biopharmaceutical company developing OPT101 as an innovative treatment for patients on peritoneal...
September 04, 2025 07:00 ET | Source: Agios Pharmaceuticals, Inc.

Agios Provides Update on U.S. PDUFA Goal Date for PYRUKYND® (mitapivat) in Thalassemia

Agios announced that the U.S. FDA has extended the PDUFA goal date for the sNDA of PYRUKYND for adults with thalassemia by three months to December 7, 2025
September 02, 2025 04:15 ET | Source: Hemex AG

Hemex expands Global Clinical Network Alliance to strengthen end-to-end CRO Capabilities

A newly established global alliance integrating specialized expertise in oncology, medical imaging, patient recruitment as well as pharmacokinetics and pharmacodynamics studiesComprehensive access to...