Latest News and Press Releases

Want to stay updated on the latest news?

Sign into Reader Account Create Reader Account

May 12, 2025 08:40 ET | Source: Moleculin Biotech, Inc.

Moleculin Receives European Medicines Agency Approval to Expand Phase 3 MIRACLE Clinical Trial

Adds nine additional countries to the Company’s ongoing pivotal Phase 3 trial; Authorization granted in all EU countries requested Enrollment and dosing underway in Phase 3 clinical trial (the...
November 13, 2024 16:14 ET | Source: NurExone Biologic Inc

NurExone Biologic Secures EMA Orphan Status for ExoPTEN in Spinal Cord Injury, Accelerating Pathway to European Markets

European Medicines Agency Awards Orphan Status to NurExone's ExoPTEN for Spinal Cord Injury, Paving the Way to European Market Entry
May 01, 2024 06:55 ET | Source: Janssen Cilag International NV

Johnson & Johnson submits regulatory applications to European Medicines Agency for TREMFYA® (guselkumab) for treatment of patients with ulcerative colitis and Crohn’s disease

Media contact:Sophie DaneauSdaneau@its.jnj.com+33 6 3178 8798Investor contact:Raychel Kruperinvestor-relations@its.jnj.com For European and UK medical and trade media only For immediate...
February 23, 2024 07:05 ET | Source: Travere Therapeutics, Inc.

Travere Therapeutics and CSL Vifor Announce Sparsentan Receives Positive CHMP Opinion for the Treatment of IgA Nephropathy

Committee for Medicinal Products for Human Use (CHMP) recommends approval of the conditional marketing authorization (CMA) for sparsentan for the treatment of IgA nephropathy (IgAN) in Europe ...
July 17, 2023 16:05 ET | Source: Aridis Pharmaceuticals, Inc.

Aridis Receives Agreement from the European Medicines Agency (EMA) on the Clinical Study Design and a Single Confirmatory Phase 3 Study of AR-301

LOS GATOS, Calif., July 17, 2023 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) today announced positive feedback from the European Medicines Agency (EMA) on the Company’s proposed...
December 20, 2022 02:00 ET | Source: Clinigen

Clinigen initiates a Managed Access Program for relugolix in Europe for the treatment of advanced hormone-sensitive prostate cancer

20 December 2022 Clinigen initiates a Managed Access Program for relugolix in Europe for the treatment of advanced hormone-sensitive prostate cancer Clinigen Limited (‘Clinigen’), the global...
May 24, 2022 07:00 ET | Source: Synlogic, Inc.

Synlogic Receives Positive Opinion on Orphan Designation from the European Medicines Agency for SYNB1618 for the Treatment of Phenylketonuria

CAMBRIDGE, Mass., May 24, 2022 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its...
March 30, 2021 08:05 ET | Source: Corbus Pharmaceuticals Holdings, Inc.

Corbus Pharmaceuticals Reports Last Subject Visit in DETERMINE Phase 3 Study of Lenabasum for Treatment of Dermatomyositis

Topline data on schedule for Q2 2021Dermatomyositis is a rare and life-threatening autoimmune disease characterized by skin and muscle inflammation, and affects ~80,000 people in North America, EU,...
March 23, 2020 08:00 ET | Source: Celsion CORP

Celsion’s GEN-1 Immunotherapy Receives Orphan Drug Designation from the European Medicines Agency

Approval Adds 10 Years of Market Exclusivity Following Marketing Authorization in Europe LAWRENCEVILLE, N.J., March 23, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), a leading...
February 19, 2020 05:45 ET | Source: Biofrontera AG

Biofrontera provides clinical development updates

Leverkusen, Germany, Feb. 19, 2020 (GLOBE NEWSWIRE) -- Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the “Company”), an international biopharmaceutical company, today provides an...

Next Page keyboard_arrow_right