Pulnovo Medical Announces PADN Receives FDA HUD Designation and US CMS Medicare Coverage Code and NMPA Approval
SHANGHAI, Jan. 2, 2024 -- (Healthcare Sales & Marketing Network) -- Pulnovo Medical Limited, a globally recognized device pioneer in the treatment of Pulmonary Hypertension (PH) and Heart Failure (HF), recently announced that it has successfully obtained ... Devices, Regulatory, FDA, Reimbursement Pulnovo Medical, PADN Catheter, pulmonary arterial hypertension (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 2, 2024 Category: Pharmaceuticals Source Type: news
HR Pharmaceuticals, Inc. receives exclusive commercialization rights to Poiesis Medical's Dual Balloon Catheter technology in North America
YORK, Pa., Dec. 28, 2023 -- (Healthcare Sales & Marketing Network) -- Today, HR Pharmaceuticals, Inc. (HRP) announced that they have entered into an Exclusive Commercial Agreement with Poiesis Medical LLC, under which HRP will license Poiesis's Dual Ballo... Devices, Licensing HR Pharmaceuticals, Poiesis Medical, Dual Balloon Catheter, Duette, Foley (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 28, 2023 Category: Pharmaceuticals Source Type: news
Lilly Completes Acquisition of POINT Biopharma
INDIANAPOLIS, Dec. 27, 2023 -- (Healthcare Sales & Marketing Network) -- Eli Lilly and Company (NYSE: LLY) today announced the successful completion of its acquisition of POINT Biopharma Global Inc. (NASDAQ: PNT), a radiopharmaceutical company with a pipe... Biopharmaceuticals, Mergers & Acquisitions Eli Lilly, POINT Biopharma Global, radioligand therapies (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 27, 2023 Category: Pharmaceuticals Source Type: news
Amgen Provides Regulatory Update on Status of Lumakras(R) (Sotorasib)
FDA Has Issued New Postmarketing Requirement
LUMAKRAS Dosing Confirmed at 960 mg Once-Daily for Patients With KRAS G12C-Mutated NSCLC Under Accelerated Approval
THOUSAND OAKS, Calif., Dec. 26, 2023 -- (Healthcare Sales & Marketing Network) -- Amgen ... Biopharmaceuticals, Oncology, FDA Amgen, LUMAKRAS, sotorasib, non-small cell lung cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 26, 2023 Category: Pharmaceuticals Source Type: news
NeuExcell's AAV Gene Therapy for Malignant Glioma Granted Orphan Drug Designation by FDA
PHILADELPHIA, Dec. 18, 2023 -- (Healthcare Sales & Marketing Network) -- On December 7, 2023, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation ("ODD") to NXL-004, an investigational AAV gene therapy product being devel... Regenerative Medicine, Neurosurgery, Oncology, FDA NeuExcell Therapeutics, malignant glioma, gene therapy, glioblastoma (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 18, 2023 Category: Pharmaceuticals Source Type: news
CymaBay Submits New Drug Application to FDA for Seladelpar for the Treatment of Primary Biliary Cholangitis
NDA is supported by data evaluating seladelpar efficacy and safety in over 500 patients
Seladelpar is the first New Drug Application from CymaBay in its ongoing mission to help people living with PBC
NEWARK, Calif., Dec. 15, 2023 -- (Healthcare Sales... Biopharmaceuticals, FDA CymaBay Therapeutics, seladelpar, primary biliary cholangitis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 15, 2023 Category: Pharmaceuticals Source Type: news
Terray Therapeutics Announces Multi-Target Collaboration with Bristol Myers Squibb
Companies to leverage Terray's tNova drug discovery platform to identify small molecule therapeutics against targets of interest. The collaboration includes an upfront payment and performance-based milestone payments, as well as royalties on global net sal... Biopharmaceuticals Terray Therapeutics, Bristol Myers Squibb (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 14, 2023 Category: Pharmaceuticals Source Type: news
Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101 in the Treatment of Patients With Refractory Myasthenia Gravis
The announcement follows the recent IND clearance for KYV-101 to be used in Kyverna's KYSA-6 Phase 2 open-label, multicenter study
KYV-101 is a fully human CD19 CAR T-cell therapy designed for use in patients with B cell-driven autoimmune diseases
EM... Biopharmaceuticals, FDA Kyverna Therapeutics, chimeric antigen receptor, Myasthenia Gravis, autoimmune (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 13, 2023 Category: Pharmaceuticals Source Type: news
Triveni Bio Welcomes Jeff Albers and Allison Luo to its Board of Directors
Board expansion marks an important strategic step as Triveni advances precision I&I pipeline
WALTHAM, Mass., Dec. 13, 2023 -- (Healthcare Sales & Marketing Network) -- Triveni Bio Inc., a biotech company pioneering a genetics-informed precision medicin... Biopharmaceuticals, Personnel Triveni Bio, inflammation, immunity (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 13, 2023 Category: Pharmaceuticals Source Type: news
cTRL Therapeutics Appoints Ruben Rodriguez, Ph.D., as Head of Research
SAN FRANCISCO, Dec. 12, 2023 -- (Healthcare Sales & Marketing Network) -- cTRL Therapeutics, a biotechnology company harnessing circulating tumor-reactive lymphocytes (cTRLs) in the blood to broaden the power and reach of solid tumor cell therapy, today a... Biopharmaceuticals, Oncology, Personnel cTRL Therapeutics, circulating tumor-reactive lymphocytes (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 12, 2023 Category: Pharmaceuticals Source Type: news
Hummingbird Bioscience Strengthens Leadership Team with Appointment of Angèle Maki as Chief Business Officer
SAN FRANCISCO and SINGAPORE, Dec. 11, 2023 -- (Healthcare Sales & Marketing Network) -- Hummingbird Bioscience, a data-driven precision biotherapeutics company discovering and developing transformative biologic medicines for hard-to-treat diseases, today ... Biopharmaceuticals, Personnel Hummingbird Bioscience (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 11, 2023 Category: Pharmaceuticals Source Type: news
AMETEK Completes Acquisition of Paragon Medical
BERWYN, Pa., Dec. 8, 2023 -- (Healthcare Sales & Marketing Network) -- AMETEK, Inc. (NYSE: AME) today announced that it has completed its acquisition of Paragon Medical, a leading provider of highly engineered medical components and instruments, from affi... Devices, Mergers & Acquisitions AMETEK, Paragon Medical (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 8, 2023 Category: Pharmaceuticals Source Type: news
BD Receives FDA 510(k) Clearance for Potentially Transformative Fingertip Blood Collection Device
BD MiniDraw Capillary Blood Collection System Enables Lab-Quality Blood Testing from Less Invasive Method than Venous Collection in More Convenient Locations
FRANKLIN LAKES, N.J., Dec. 7, 2023 -- (Healthcare Sales & Marketing Network) -- BD (Becton, D... Devices, Diagnostics, FDA BD , MiniDraw, Capillary Blood Collection (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 7, 2023 Category: Pharmaceuticals Source Type: news
NSite Medical Announces FDA Clearance for Groundbreaking AI-Based Scoliosis Scanning App
MENLO PARK, Calif., Dec. 6, 2023 -- (Healthcare Sales & Marketing Network) -- NSite Medical, a leader in scoliosis care and treatment, is excited to announce the FDA clearance of its innovative AI-based Scoliosis Assessment Application. This technological... Devices, FDA NSite Medical, Scoliosis Assessment app (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 6, 2023 Category: Pharmaceuticals Source Type: news
ABK Biomedical Announces That its Eye90 Microspheres(R) Device Has Been Granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA)
HALIFAX, NS, Dec. 5, 2023 -- (Healthcare Sales & Marketing Network) - ABK Biomedical, Inc., an innovative, medical device company dedicated to the research, development, and commercialization of advanced imageable embolic therapies, announces its Eye90 mi... Devices, Oncology, FDA ABK Biomedical, Eye90 microspheres, Hepatocellular Carcinoma, embolic therapy (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 5, 2023 Category: Pharmaceuticals Source Type: news
