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ZyVersa Therapeutics’ CEO, Stephen C. Glover, to Participate in BIO Partnering @ JPM During “J.P. Morgan Week 2024”
12/18/2023
ZyVersa Therapeutics, Inc. announces that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President, will participate in BIO Partnering @ JPM being held January 8-12, 2024 in San Francisco.
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Neuren Phase 2 trial shows significant improvements in Phelan-McDermid syndrome
12/18/2023
Neuren Pharmaceuticals (ASX: NEU) today announced top-line results from its Phase 2 clinical trial of NNZ-2591 in children with Phelan-McDermid syndrome (PMS).
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Spectrum Solutions Names Bill Phillips as New Chief Executive Officer
12/18/2023
Spectrum Solutions® and its owned corporations, Alimetrix, Inc., and Microarrays, Inc., announced the appointment of Bill Phillips as the company’s new chief executive officer, replacing Stephen J. Fanning, who successfully served as Spectrum’s CEO for over four years.
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Anagenex and Nimbus Announce a Multi-Target Collaboration to Discover Small Molecule Therapeutics for Multiple Indications
12/18/2023
Anagenex and Nimbus Therapeutics announced they have initiated a research collaboration.
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Provectus Biopharmaceuticals Announces Notice of Allowance of First U.S. Patent of Rose Bengal Sodium for Use as Anticancer and Antiviral Vaccine Adjuvant
12/18/2023
Provectus (OTCQB: PVCT) today announced that the United States Patent and Trademark Office (USPTO) has allowed patent application 17/488,430, titled “Halogenated Xanthenes as Vaccine Adjuvants.”
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Successful Transfer of New Drug Application (NDA), Acknowledged by U.S. FDA, from Former Zosano Pharma to Emergex for Investigational Microneedle-Based Drug Delivery Patch
12/18/2023
Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’) today announced that the Company has transferred ownership, as of May 2023, of the existing U.S. Food and Drug Administration (FDA) New Drug Application (NDA) of the investigational MAP originally intended for the epidermal delivery of zolmitriptan1 (also known as M207) for the treatment of migraine attacks in adults.
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PepGen Announces First Patient Dosed in Phase 1 FREEDOM-DM1 Clinical Trial of PGN-EDODM1 for Myotonic Dystrophy Type 1 (DM1)
12/18/2023
PepGen Inc. (Nasdaq: PEPG) today announced that the first patient has been dosed in its Phase 1 clinical trial, FREEDOM-DM1, evaluating PGN-EDODM1 for the treatment of DM1.
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Harvard Apparatus Regenerative Technology and the McGowan Institute for Regenerative Medicine at the University of Pittsburgh Establish a Research Collaboration to Study the Repair and Regeneration of the Colon following Colectomy
12/18/2023
Harvard Apparatus Regenerative Technology, Inc. announced that it officially executed a sponsored research agreement with Drs. Stephen Badylak, George Hussey and Vincent Anto at the McGowan Institute for Regenerative Medicine, a center of the University of Pittsburgh and UPMC focused on developing regenerative therapies to address organ and tissue failure.
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ICON Wins Industry Accolades from TIME Magazine, Forbes and Financial Times in Second Half of 2023
12/18/2023
ICON plc, a world-leading healthcare intelligence and clinical research organisation, finishes the second half of 2023 with positive recognition as a top-rated employer and leader in clinical trial innovation.
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Recce Pharmaceuticals Reports Positive Preclinical Data of RECCE® 327 Against Gonorrhea
12/18/2023
Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) (the Company) today announced positive preclinical results from an in vivo study evaluating the antibacterial efficacy of its lead synthetic anti-infective candidate, RECCE® 327 (R327), against Neisseria gonorrhoeae (N. gonorrhoeae) in a mouse vaginal infection model.
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Ultragenyx Receives European Commission Decision for Evkeeza® (evinacumab) Expanded Indication in Children Aged 5 Years and Older with Homozygous Familial Hypercholesterolemia (HoFH)
12/18/2023
Ultragenyx Pharmaceutical Inc. announced that the European Commission has extended the approval of Evkeeza® as an adjunct to diet and other lipid-lowering therapies to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia.
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Elutia Submits CanGarooRM® Antibiotic-Eluting Biomatrix for FDA Clearance
12/18/2023
Elutia Inc. (Nasdaq: ELUT) today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its next-generation drug-eluting biomatrix product, CanGarooRM®.
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GC Biopharma Announces US FDA Approval for ALYGLO™ (Immune Globulin Intravenous, Human-stwk) 10% Liquid for Adults with Primary Humoral Immunodeficiency (PI)
12/18/2023
GC Biopharma Corp announces that the US Food and Drug Administration has approved ALYGLO 10% Liquid, formerly referred to as "GC5107," for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency.
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Align Technology Receives US FDA 510(k) Clearance for the Invisalign® Palatal Expander System to Address Skeletal & Dental Expansion in Growing Patients, Including Teenage Patients Which Represent the Majority of Orthodontic Case Starts Globally
12/18/2023
Align Technology, Inc., a leading global medical device company that designs, manufactures, and sells the Invisalign® System of clear aligners, iTero™ intraoral scanners, and exocad™ CAD/CAM software for digital orthodontics and restorative dentistry, announced that the U.S. Food and Drug Administration has cleared Align’s Invisalign® Palatal Expander System* for commercial availability in the U.S.
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IntelGenx Announces New Animal Health Partnership; Enters into Development and License Agreements for VetaFilm®
12/18/2023
IntelGenx Corp. announced that it has entered into development and license agreements with a wholly-owned subsidiary of Covenant Animal Health Partners, LLC.
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Nuvectis Pharma, Inc. Announces a Collaboration with Mayo Clinic to Evaluate NXP800 in an Investigator-Sponsored Clinical Trial in Cholangiocarcinoma
12/18/2023
Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced a collaboration with Mayo Clinic to evaluate NXP800 in an Investigator-sponsored clinical trial in cholangiocarcinoma.
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Neuronetics Receives 510(k) Clearance for NeuroSite™ Coil Placement Accessory
12/18/2023
Neuronetics, Inc., a medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, announced the U.S. Food and Drug Administration 510 clearance of NeuroSite™ Coil Placement Accessory, a state-of-the-art tool that simplifies measurement and coil positioning during NeuroStar transcranial magnetic stimulation treatments.
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InnoCare Appoints Xin Fu as Chief Financial Officer
12/18/2023
InnoCare Pharma, a leading biopharmaceutical company focusing on cancer and autoimmune diseases, announced that the Company appointed Mr. Xin Fu, who has extensive finance-related experience, as the Chief Financial Officer.
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Tyber Medical Granted FDA Clearance on Distal Radius Plating System
12/18/2023
Tyber Medical, LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, received a U.S. Food and Drug Administration (FDA) 510(k) clearance for its new Distal Radius Plating System.
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Nexalin Technology Reports Significant Positive Results of Clinical Study Supporting the Therapeutic Benefits of its Gen-2, 15 Milliamp Neurostimulation Device on Treatment-Resistant Depression
12/18/2023
Nexalin Technology, Inc. reported the results of a study in patients with treatment-resistant depression, concerning the potential therapeutic benefits of its second-generation, 15 milliamp neurostimulation device, which indicated a substantial and statistically significant benefit in patients.