Drugs.com - Clinical Trials

Innovent Receives Second Fast Track Designation from the U.S. FDA for IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Squamous Non-Small Cell Lung Cancer

Innovent Receives Second Fast Track Designation from th...

Feb 27, 2025 0

SAN FRANCISCO, U.S. and SUZHOU, China, February 17, 2025 — Innovent Biologics, I...

U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review

U.S. FDA Accepts Gilead’s New Drug Applications for Twi...

Feb 27, 2025 0

FOSTER CITY, Calif.--(BUSINESS WIRE) February 18, 2025 -- Gilead Sciences, Inc....

Pyxis Oncology Granted FDA Fast Track Designation for PYX-201 Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer

Pyxis Oncology Granted FDA Fast Track Designation for P...

Feb 27, 2025 0

BOSTON, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a...

Camizestrant Demonstrated Highly Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in 1st-Line Advanced HR-Positive Breast Cancer with an Emergent ESR1 Tumor Mutation in SERENA-6 Phase III Trial

Camizestrant Demonstrated Highly Statistically Signific...

Feb 27, 2025 0

26 February 2025 -- Positive high-level results from a planned interim analysis ...

Opus Genetics Announces FDA Fast Track and Enrollment Updates for Phentolamine Ophthalmic Solution 0.75% Programs

Opus Genetics Announces FDA Fast Track and Enrollment U...

Feb 27, 2025 0

DURHAM, N.C., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD...

$Auron Therapeutics Announces AUTX-703 Granted Fast Track Designation by the FDA for Relapsed or Refractory Acute Myelogenous Leukemia$

Auron Therapeutics Announces AUTX-703 Granted Fast Trac...

Feb 26, 2025 0

Newton, MA, February 24, 2025 – Auron Therapeutics, a clinical-stage biotechnolo...

Boehringer’s Zongertinib Receives Priority Review from U.S. FDA for the Treatment of HER2 (ERBB2)-Mutant Advanced Non-Small Cell Lung Cancer

Boehringer’s Zongertinib Receives Priority Review from ...

Feb 20, 2025 0

Ridgefield, Conn., and Ingelheim, Germany, Feb. 19, 2025 -- Boehringer Ingelheim...

Clarity Receives US FDA Fast Track Designation for the Treatment of Metastatic Castration-Resistant Prostate Cancer Patients with Cu-67 SAR-bisPSMA

Clarity Receives US FDA Fast Track Designation for the ...

Feb 20, 2025 0

Sydney, Australia 19 February 2025 Clarity Pharmaceuticals (ASX: CU6) (“Clarity”...

Lundbeck’s Potential Treatment Amlenetug for Multiple System Atrophy Receives Fast Track Designation From the FDA

Lundbeck’s Potential Treatment Amlenetug for Multiple S...

Feb 17, 2025 0

Wed, Feb 12, 2025 -- The FDA has granted Fast Track Designation to Lundbeck’s in...

FDA Grants Fast Track Designation to PleoPharma, Inc's Investigational New Drug, PP-01, for the Mitigation of Cannabis Withdrawal Symptoms in Patients With Cannabis Use Disorder

FDA Grants Fast Track Designation to PleoPharma, Inc's ...

Feb 17, 2025 0

PHOENIXVILLE, Pa., Feb. 13, 2025 /PRNewswire/ -- PleoPharma, Inc., a privately h...

$Innate Pharma Announces U.S. FDA Granted Breakthrough Therapy Designation to Lacutamab for Relapsed or Refractory Sézary Syndrome$

Innate Pharma Announces U.S. FDA Granted Breakthrough T...

Feb 17, 2025 0

February 17, 2025 -- Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Inna...

Palvella Therapeutics to Expand Phase 3 SELVA Clinical Trial of Qtorin 3.9% Rapamycin Anhydrous Gel (Qtorin rapamycin) for the Treatment of Microcystic Lymphatic Malformations to Include the Younger Pediatric Population, Children 3 to 5 Years Old

Palvella Therapeutics to Expand Phase 3 SELVA Clinical ...

Feb 13, 2025 0

WAYNE, Pa., Feb. 10, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeuti...

Tempest Granted Fast Track Designation from the U.S. Food and Drug Administration for Amezalpat to Treat Patients with Hepatocellular Carcinoma

Tempest Granted Fast Track Designation from the U.S. Fo...

Feb 13, 2025 0

BRISBANE, Calif., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (...

Spinogenix Completes Phase 2 Study of SPG601 for Treatment of Fragile X Syndrome, a Common Inherited Form of Autism, Showing Strong Efficacy Signal in Measures of Abnormal Brain Activity

Spinogenix Completes Phase 2 Study of SPG601 for Treatm...

Feb 13, 2025 0

LOS ANGELES, Calif., February 11, 2025 — Spinogenix, Inc., a clinical-stage biop...

Allarity Therapeutics Announces Expansion of Phase 2 Clinical Trial to Accelerate Development of Stenoparib in Advanced Ovarian Cancer

Allarity Therapeutics Announces Expansion of Phase 2 Cl...

Feb 10, 2025 0

Boston (February 6, 2025)—Allarity Therapeutics, Inc. (“Allarity” or the “Compan...

Pliant Therapeutics Provides Update on BEACON-IPF, a Phase 2b/3 Trial of Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis

Pliant Therapeutics Provides Update on BEACON-IPF, a Ph...

Feb 10, 2025 0

SOUTH SAN FRANCISCO, Calif., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeuti...

Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Moderate-to-Severe Atopic Dermatitis

Nektar Therapeutics Receives Fast Track Designation for...

Feb 10, 2025 0

SAN FRANCISCO, Feb. 10, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) ...

Boehringer’s Nerandomilast Meets Primary Endpoint in Phase III Study FIBRONEER™-ILD, in Progressive Pulmonary Fibrosis

Boehringer’s Nerandomilast Meets Primary Endpoint in Ph...

Feb 10, 2025 0

Ingelheim, Germany, February 10, 2025 - Boehringer Ingelheim announced today th...

U.S. FDA Grants Orphan Drug Designation to Ariceum Therapeutics’ Proprietary Radiopharmaceutical Cancer Therapy

U.S. FDA Grants Orphan Drug Designation to Ariceum Ther...

Feb 10, 2025 0

Berlin, Germany, 6 February 2025 – Ariceum Therapeutics (Ariceum), a private bio...

Salarius Pharmaceuticals Announces Patient Enrollment to Resume in Investigator-initiated Phase 1/2 Clinical Trial Using Seclidemstat with Azacitidine to Treat Hematologic Cancers

Salarius Pharmaceuticals Announces Patient Enrollment t...

Feb 9, 2025 0

HOUSTON, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasda...

Eledon Pharmaceuticals Announces Use of Tegoprubart as Key Component of Immunosuppression Regimen in its Second Transplant of a Genetically Modified Pig Kidney into a Human

Eledon Pharmaceuticals Announces Use of Tegoprubart as ...

Feb 9, 2025 0

IRVINE, Calif., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (...

$GSK’s B7-H3-Targeted Antibody-Drug Conjugate, GSK’227, Receives US FDA Breakthrough Therapy Designation in Late-Line Relapsed or Refractory Osteosarcoma$

GSK’s B7-H3-Targeted Antibody-Drug Conjugate, GSK’227, ...

Feb 9, 2025 0

London, UK January 07 2025 -- GSK plc (LSE/NYSE: GSK) announced today that the U...

Datopotamab Deruxtecan Granted Priority Review in the US for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer

Datopotamab Deruxtecan Granted Priority Review in the U...

Feb 9, 2025 0

13 January 2025 -- AstraZeneca and Daiichi Sankyo’s Biologics License Applicatio...

Adaptimmune Announces U.S. FDA Breakthrough Therapy Designation Granted to Letetresgene Autoleucel (lete-cel) for Treatment of Myxoid/Round Cell Liposarcoma (MRCLS)

Adaptimmune Announces U.S. FDA Breakthrough Therapy Des...

Feb 9, 2025 0

Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - January...

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