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Journey Medical Corporation Announces Positive Topline Results from its Two Phase 3 Clinical Trials (MVOR-1 and MVOR-2) Evaluating DFD-29 for the Treatment of Papulopustular Rosacea in Adults
7/11/2023
Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”) today announced positive topline results from the two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea® in Rosacea-1 (“MVOR-1”) and Minocycline Versus Oracea in Rosacea-2 (“MVOR-2”), evaluating Minocycline Hydrochloride Modified Release Capsules, 40 mg (“DFD-29”) for the treatment of moderate-to-severe papulopustular rosacea in adults.
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DISCOVERY LIFE SCIENCES ACCELERATES CLINICAL TRIALS WITH ADDITION OF FULL-SPECTRUM CLINICAL FLOW CYTOMETRY
7/11/2023
Discovery Life Sciences (Discovery), the Biospecimen and Biomarker Specialists, announces the launch of state-of-the-art flow cytometry clinical trial services.
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LARGEST STUDY ON RACIAL DIFFERENCES IN MEN WITH MELANOMA SHOWS MEN WITH SKIN OF COLOR HAVE LOWEST SURVIVAL RATES
7/11/2023
Melanoma, the most serious form of skin cancer, is highly treatable when detected early, but when the disease advances, it can lead to death.
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Orsini Selected by BioMarin to Dispense ROCTAVIAN™, the First Gene Therapy for the Treatment of Severe Hemophilia A
7/11/2023
Orsini Specialty Pharmacy, a leading independent specialty pharmacy focused on rare diseases and gene therapies, announced today that BioMarin Pharmaceutical has selected it to dispense ROCTAVIAN™ (valoctocogene roxaparvovec-rvox).
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Kytopen Announces Collaboration with leading bioengineer Omid Veiseh, PhD. to Fuel Genome Engineering Research and Accelerate Cell Therapy Discovery
7/11/2023
Kytopen, a leading biotechnology company specializing in scalable gene editing platforms, today announces a strategic collaboration with Rice University's prestigious Omid Veiseh Laboratory.
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Purple Biotech Reports Positive Results of CM24 Dose Escalation in Advanced Pancreatic Cancer Patients
7/11/2023
Purple Biotech Ltd. today announced the completion and data maturity of its Phase 1 dose escalation study of CM24, a first-in-class anti-CEACAM1 monoclonal antibody addressing multiple tumor types.
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CoJourney Inc. Secures $30 Million Financing and Announces Expansion of US Operations: High Quality, Cost Effective, Commercial Scale Manufacturing Platform for Cell and Gene Therapies
7/11/2023
CoJourney Inc. a global innovator in manufacturing and development of cell and gene therapies is pleased to announce completion of a $30 M Series A financing and expansion of its US organization and commercial manufacturing capabilities.
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Urotronic Announces FDA Approval of Optilume® BPH Catheter System, Pioneering the Next Generation of Minimally Invasive Solutions for Enlarged Prostate Symptom Relief
7/11/2023
Urotronic, Inc. today announced it has received U.S. Food and Drug Administration (FDA) approval of its Optilume® BPH Catheter System, a unique minimally invasive surgical therapy (MIST) that combines mechanical dilation using a proprietary double-lobe balloon with concurrent localized delivery of paclitaxel for the treatment of lower urinary tract symptoms (LUTS) secondary to BPH.
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MEI Pharma Provides Final Reminder to Shareholders to Vote Today FOR the Merger With Infinity Pharmaceuticals
7/11/2023
MEI Pharma, Inc. (NASDAQ: MEIP) (the “Company”) today reminded shareholders to vote FOR the Company’s pending transaction with Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) (“Infinity”) in connection with the upcoming special meeting on July 14, 2023.
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SYNAPS Dx DISCERN™ Test Provides Accurate Diagnosis of Alzheimer’s Disease, Optimizes Prescribing, Minimizes Patient Risks and Informs Coverage Decisions for Leqembi™
7/11/2023
SYNAPS Dx (SDx) a privately held company focused on the research, development and commercialization of a diagnostic test for Alzheimer’s disease (AD), recognizes the historic Food and Drug Administration (FDA) approval of Leqembi, the first drug shown to slow the progression of AD.
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Data Published in Transplantation and Cellular Therapy Suggest Antiviral Protection After Transplantation with Gamida Cell’s Omisirge® (omidubicel-onlv)
7/11/2023
Gamida Cell Ltd. today announced the publication in press of a prospective sub-study of the Phase 3 clinical trial for Omisirge® (omidubicel-onlv), the company’s allogeneic stem cell transplant therapy, characterizing immune reconstitution kinetics following hematopoietic stem cell transplantation (HCT) with Omisirge compared to umbilical cord blood (UCB).
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Achieve Life Sciences Announces Publication of Cytisinicline Phase 3 ORCA-2 Smoking Cessation Trial in Journal of the American Medical Association (JAMA)
7/11/2023
Achieve Life Sciences, Inc. (NASDAQ: ACHV), today announced the publication in JAMA of the results from the Phase 3 ORCA-2 randomized placebo-controlled clinical trial of cytisinicline as a treatment for smoking cessation, the first large trial of this medication conducted in the United States.
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AccurKardia’s AccurECG™ Analysis System Receives FDA 510(k) Clearance
7/11/2023
AccurKardia announced today that its flagship product, the AccurECG™ Analysis System (“AccurECG” or the “System”), has been granted FDA 510(k) clearance.
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Invictus Announces FDA Clearance of Ground-Breaking Neoasis® ANC Device
7/11/2023
Invictus Medical announced today that the culmination of their De Novo application to the FDA for its Neoasis® incubator-based active noise control (ANC) device has resulted in a clearance-for-use declaration by the FDA.
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Fresenius Kabi Introduces New Presentation for Fentanyl Citrate Injection, USP in Simplist® Ready-to-Administer Prefilled Syringes
7/11/2023
Fresenius Kabi Introduces New Presentation for Fentanyl Citrate Injection, USP in Simplist ® Ready-to-Administer Prefilled Syringes.
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NeuroSense to Participate in Upcoming ALS Conferences: European Network to Cure ALS & EverythingALS Digital Biomarkers Summit
7/11/2023
NeuroSense Therapeutics Ltd. announced it will participate in two upcoming conferences that aim to advance treatments and solutions to improve the lives of people living with amyotrophic lateral sclerosis.
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Acerus Update - July 11, 2023
7/11/2023
Acerus Pharmaceuticals Corporation announces that, in connection with its creditor protection proceedings under the Companies’ Creditors Arrangement Act and its previously announced sale and investment solicitation process, the Company completed the previously announced transactions with First Generation Capital Inc. as successful bidder under the SISP.
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First U.S. Patients Implanted with Innovative FIRE1 Remote Heart Failure Monitoring System in Early Feasibility Study
7/11/2023
FIRE1 today announced that the first U.S. patients have been successfully implanted with its FIRE1™ System for remote heart failure monitoring in an Early Feasibility Study.
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First Patient Dosed in SAR’514 / IPH6401 Phase 1/2 Clinical Trial in Relapsed/Refractory Multiple Myeloma
7/11/2023
Innate Pharma SA announced that the first patient was dosed in a Sanofi-sponsored Phase 1/2 clinical trial, evaluating SAR’514 / IPH6401 in relapsed/refractory Multiple Myeloma and Relapsed/Refractory Light-chain Amyloidosis 1.
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Hyperfine, Inc. Launches Observational Study to Define New Imaging Paradigm in Stroke Care
7/11/2023
Hyperfine, Inc. has announced the commencement of an international, multi-site observational study, ACTION PMR.