Product News
Filter News
Found 273,675 articles
-
Keytruda can now be used in the European Union for patients with resectable non-small cell lung cancer at high risk of recurrence in combination with platinum chemotherapy, then continued as a monotherapy afterwards.
-
HUTCHMED Announces Savolitinib sNDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC
3/28/2024
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the supplemental New Drug Application (“sNDA”) for savolitinib, in adult patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) with mesenchymal epithelial transition factor (“MET”) exon 14 skipping alteration, has been accepted for review by the China National Medical Products Administration (NMPA).
-
Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia
3/28/2024
Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for govorestat (AT-007) for the treatment of Classic Galactosemia by three months.
-
Sirnaomics Announces 2023 Annual Results
3/28/2024
Sirnaomics Ltd., a leading biopharmaceutical company engaged in the discovery and development of advanced RNAi therapeutics, has announced its audited annual results for the year ended 31 December 2023.
-
Photomedicine Pioneer CLINUVEL Unveils Clinical, Cosmetic Ambitions to German Investors
3/28/2024
Pioneering biopharmaceutical company CLINUVEL yesterday hosted a wide-ranging market briefing discussing its novel drug SCENESSE® and the future of photomedicine.
-
European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy as Adjuvant Treatment, for Resectable Non-Small Cell Lung Cancer at High Risk of Recurrence in Adults
3/28/2024
Merck, known as MSD outside of the United States and Canada, announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer at high risk of recurrence in adults.
-
Intravacc and Primrose Bio Announce Partnership to Enhance Conjugate Vaccine Development
3/28/2024
Intravacc and Primrose Bio announced a strategic partnership to enhance the development and supply of conjugate vaccines.
-
CLS Americas Announces ROSE Urology will use TRANBERG Laser to Treat Prostate Cancer Patients with Focal Laser Ablation
3/28/2024
Clinical Laserthermia Systems Americas, Inc. announced that ROSE Urology, LLC, located in Vero Beach, Florida, will begin using the TRANBERG™ Thermal Therapy System to treat prostate cancer patients.
-
Affimed Reports 2023 Financial Results and Operational Progress
3/28/2024
Affimed N.V., a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported financial results and provided an update on clinical and corporate progress for the year ended December 31, 2023.
-
Exact Sciences Advances Development of Non-Endoscopic Oncoguard® Esophagus Test to Screen for Esophageal Cancer and Pre-Cancer
3/28/2024
Exact Sciences Corp. in collaboration with Mayo Clinic Comprehensive Cancer Center, reported on data showing high sensitivity and specificity for the non-endoscopic Oncoguard® Esophagus test that is currently in development for the detection of esophageal adenocarcinoma and its precursors, including Barrett’s esophagus.1,2 Findings from the test’s algorithm training and testing were recently published in the Clinical Gastroenterology and Hepatology journal.
-
Confo Therapeutics Secures VLAIO Grant Supporting Drug Discovery & Development in Endocrine and Metabolic Diseases
3/28/2024
Confo Therapeutics, a leader in the discovery of novel medicines targeting G-protein coupled receptors, announced that it has been awarded a EUR 1.6 million grant from Flanders Innovation & Entrepreneurship.
-
89bio Receives EMA PRIME Status for Pegozafermin in the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) with Fibrosis and Compensated Cirrhosis
3/27/2024
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) status to pegozafermin in patients with MASH.
-
Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce FDA Clearance of the Investigational New Drug Application for Naronapride to Treat Gastroparesis and Subsequent Expansion of the Ongoing Phase 2b MOVE-IT Study to the United States
3/27/2024
Renexxion Ireland Limited (“Renexxion”), a private biopharmaceutical company committed to delivering innovative drugs to patients with high unmet need in gastrointestinal (“GI”) disorders, and European partner, Dr. Falk Pharma GmbH (“Dr. Falk Pharma”), announce U.S Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for naronapride to treat patients with gastroparesis.
-
Patent Allowance Granted for ALA-002 Composition by US Patent and Trademark OfficeNovel Composition of MDMA Enantiomers leading to next-generation MDMA possibilities
3/27/2024
PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF) is extremely pleased to announce that the US Patent and Trademark Office (USPTO) has indicated it is issuing an allowance for the granting of a patent for ALA-002, the company’s lead investigational MDXX Novel Chemical Entity (NCE).
-
Tellbio’s Technology Demonstrates that Analysis of Circulating Tumor Cells Can Predict Survival Among Patients with Metastatic Castration-Resistant Prostate Cancer Receiving Radium-2230
3/27/2024
TellBio, Inc., a development-stage medical technology company focused on revolutionizing the detection of cancer metastasis through its unique and proprietary circulating tumor cell (CTC) technology, the TellDx CTC System, announces the publication of data that shows the promise of CTCs as a prognostic biomarker for patients with prostate cancer receiving novel therapies such as radium-223.
-
Allarity Therapeutics Makes Strategic Pivot to Focus Solely on Accelerating Stenoparib Toward Regulatory Approval in Advanced Recurrent Ovarian Cancer
3/27/2024
Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR) today announced a strategic pivot aimed at advancing its clinical-stage candidate stenoparib, a novel PARP/Tankyrase dual inhibitor, toward registration in advanced recurrent ovarian cancer, leveraging its DRP® platform to identify and enroll only the patients most likely to derive clinical benefit.
-
MIMEDX Provides Update on AXIOFILL® Request for Designation (“RFD”) from FDA
3/27/2024
MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today announced that the U.S. Food and Drug Administration (“FDA”) has issued a determination letter in connection with the RFD process related to AXIOFILL, a human-derived particulate wound dressing.
-
One-on-One, Surgeon-to-Surgeon Bunionplasty® Procedure Training Program Sets New Industry Standard for Minimally Invasive Bunion Surgery Adoption
3/27/2024
Voom™ Medical Devices, Inc. ("Voom"), a revolutionary medical device company transforming the landscape of minimally invasive bunion surgery (MIBS) education, is thrilled to announce the official launch of its new one-on-one surgeon training program for the Bunionplasty® 360 Bunion Repair™ procedure.
-
Hoth Therapeutics' Wholly Owned Subsidiary Merveille.ai, Advances AI-Driven Discovery for Obesity Treatment
3/27/2024
Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient focused biopharmaceutical company, is excited to announce a significant breakthrough by its subsidiary, Merveille.ai, in the field of obesity treatment.
-
Patients in Utah Now Have Access to the Novel Revi™ Implantable Tibial Neuromodulation Device for the Treatment of Urge Urinary Incontinence
3/27/2024
BlueWind Medical, Ltd., a pioneer in the development and commercialization of a patient-centric implantable Tibial NeuroModulation (iTNM) solution for urge urinary incontinence (UUI), is excited to announce that Revi is now available in Utah with urologist Dr. Sara Lenherr at the University of Utah.