Clinical Trial News & Results
This section provides information about recently completed clinical trials. If you cannot find information about a particular clinical trial, you should note that results may not be available even after the trial ends. Some trials end before completion and results are never published.
Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Severe-to-Very Severe Alopecia Areata
SAN FRANCISCO, July 29, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that the U.S. Food and Drug Administration (FDA) has granted...
Calidi Biotherapeutics Receives FDA Fast Track Designation for CLD-201 (SuperNova), a First-In-Class Stem-Cell Loaded Viral Therapy for the Treatment of Patients with Soft Tissue Sarcoma
SAN DIEGO, July 29, 2025 (GLOBE NEWSWIRE) — Calidi Biotherapeutics, Inc. (“Calidi” or the “Company”) (NYSE American: CLDI), a...
Serina Therapeutics Advances POZ-VMAT2i into Development for Tardive Dyskinesia (TD)
HUNTSVILLE, AL, July 29, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology...
Bayer Provides Regulatory Update on Elinzanetant for the Treatment of Moderate to Severe Hot Flashes Due to Menopause
WHIPPANY, N.J.--(BUSINESS WIRE) July 25, 2025 --Bayer today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the...
Gefurulimab Dual-Binding Nanobody Demonstrated Statistically Significant and Clinically Meaningful Improvement in Functional Activities of Daily Living in Adults with Generalised Myasthenia Gravis in PREVAIL Phase III Trial
24 July 2025 -- Positive high-level results from a global, randomised, double-blind, placebo-controlled Phase III trial in adults with anti-acetylcholine...
Verastem Oncology Granted Fast Track Designation for VS-7375 for the Treatment of KRAS G12D-mutated Locally Advanced or Metastatic Pancreatic Cancer
BOSTON--(BUSINESS WIRE)--Jul. 24, 2025-- Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with...
Avidity Biosciences Receives FDA Breakthrough Therapy Designation for Delpacibart Zotadirsen (del-zota) for the Treatment of DMD in People with Mutations Amenable to Exon 44 Skipping
SAN DIEGO, July 23, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA...
Revolution Medicines Announces FDA Breakthrough Therapy Designation for Elironrasib
REDWOOD CITY, Calif., July 23, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted...
Apnimed Reports Positive Topline Results from Second Phase 3 Trial of AD109, Reinforcing Potential of First Oral Pill for Obstructive Sleep Apnea
CAMBRIDGE, Mass., July 23, 2025 – Apnimed, Inc., a pharmaceutical company advancing an industry-leading pipeline of first-in-class oral therapies that a...
Abivax Announces Positive Phase 3 Results from Both ABTECT 8-Week Induction Trials Investigating Obefazimod, its First-in-Class Oral miR-124 Enhancer, in Moderate to Severely Active Ulcerative Colitis
PARIS, France – July 22, 2025 – 10:05 PM CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or...
Takeda Receives FDA 510(k) Clearance for HyHub™ and HyHub™ Duo Devices to Simplify Hyqvia Administration
OSAKA, Japan and CAMBRIDGE, Massachusetts, July 21, 2025 – Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA)...
Genentech Provides Update on Astegolimab in Chronic Obstructive Pulmonary Disease
South San Francisco, CA -- July 20, 2025 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today topline results from the...
FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold for Multiple Gene Therapy Products Following Three Deaths
July 18, 2025 -- The U.S. Food and Drug Administration today announced it has placed Sarepta Therapeutics investigational gene therapy clinical trials for limb...
Praxis Precision Medicines Receives FDA Breakthrough Therapy Designation for Relutrigine for the Treatment of Seizures Associated with SCN2A and SCN8A Developmental and Epileptic Encephalopathies
BOSTON, July 17, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic...
Johnson & Johnson Receives U.S. FDA Priority Review for TAR-200 NDA in High-Risk Non-Muscle Invasive Bladder Cancer
RARITAN, N.J., JULY 17, 2025 – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) granted Priority Review...
Update on CARES Phase III Clinical Programme of Anselamimab in Light Chain Amyloidosis
16 July 2025 -- High-level results from the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase III clinical programme showed that anselamimab, a...
Shorla Oncology Announces FDA Orphan Drug Designation for SH-110 to Treat Rare Brain Cancer Using Oral Liquid
CAMBRIDGE, Mass.--(BUSINESS WIRE) Jul 15, 2025 --Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that...
Adagene Announces Regulatory Update on Clinical Development Plan for Muzastotug in Microsatellite Stable Colorectal Cancer Following Productive Type B (End of Phase 1) Meeting with FDA
SAN DIEGO and SUZHOU, China, July 15, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene or the Company”) (Nasdaq: ADAG), a company transforming the...
Shorla Oncology Announces FDA Orphan Drug Designation for SH-110 to Treat Rare Brain Cancer Using Oral Liquid
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- July 15, 2025 -- Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today...
Takeda Announces Positive Results from Two Pivotal Phase 3 Studies of Oveporexton (TAK-861) in Narcolepsy Type 1
OSAKA, Japan and CAMBRIDGE, Massachusetts, July 14, 2025 – Takeda (TSE:4502/NYSE:TAK) today announced that all primary and secondary endpoints were met...
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More news resources
- FDA Medwatch Drug Alerts
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