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Pharma News for Merck, AbbVie, Abbisko
Merck to Acquire Harpoon Therapeutics; Novo Nordisk Enters Into Collaborations with Omega Therapeutics and Cellarity; AbbVie’s Lutikizumab’s Phase II Trial Result for Hidradenitis Suppurativa; Abbisko’s CSF-1R Inhibitor Pimicotinib (ABSK021); Cabaletta Bio’s CABA-201; FDA Grants Fast Track” Designation for Soligenix’s Dusquetide

Lutikizumab Showed Positive Results in a Phase II Trial of Adults with Moderate to Severe Hidradenitis Suppurativa as Program Advances to Phase III AbbVie has reported the results of Phase II trials indicating that adults experiencing moderate to severe hidradenitis suppurativa, and who had previously not respon...

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Pharma News for Cytokinetics, Chiesi, AstraZeneca, Zevra
Cytokinetics Announces Results From SEQUOIA-HCM Clinical Trial of Aficamten; FDA Approves Chiesi’s FILSUVEZ Topical Gel; Bristol Myers Squibb Adds Premier Radiopharmaceutical Platform; AstraZeneca to Acquire Gracell; Zevra Therapeutics Announces Resubmission of Arimoclomol New Drug Application; Innovent Dosed First Participant in Phase 3 Clinical Study (GLORY-2) of Mazdutide (IBI362)

Cytokinetics Announces Positive Results From SEQUOIA-HCM, the Pivotal Phase III Clinical Trial of Aficamten in Patients With Obstructive Hypertrophic Cardiomyopathy Cytokinetics, Incorporated released favorable top-line findings from the SEQUOIA-HCM trial (Safety, Efficacy, and Quantitative Understanding of Obst...

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Pharma News for Amylyx, Sellas, Apnimed, Ocelot
ImPact Biotech’s IND Application for Padeliporfin VTP; Orphan Drug Designation to Ocelot Bio’s OCE-205 for Ascites; Amylyx’s Phase 3 ORION Study of AMX0035 for PSP; SELLAS Receives FDA Orphan Drug Designation for SLS009 for PTCL Treatment; Apnimed Updated on Second Phase 3 Clinical Study of AD109 for OSA

ImPact Biotech Receives FDA Clearance of IND Application for Padeliporfin VTP in Pancreatic Cancer ImPact Biotech, a biotechnology company in its clinical stage dedicated to advancing Padeliporfin Vascular Targeted Photodynamic (VTP) therapy for various solid tumors, announced on December 20, 2023, that the U.S....

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Pharma News for Eisai, Biogen, Merck, BMS, Kyverna
Eisai Submits Marketing Authorization Application for Tasurgratinib; CHMP Issues Positive Opinion for Biogen’s SKYCLARYS; European Commission Approves Merck’s KEYTRUDA + Chemotherapy HER2-ve Gastric or GEJ Adenocarcinoma; BMS Provides Update on RELATIVITY-123 Trial; Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101; Verrica and Torii Pharma Announces Positive Top-line Results from a Confirmatory Phase 3 Trial of TO-208

Eisai Submits Marketing Authorization Application In Japan for Anticancer Agent Tasurgratinib For Biliary Tract Cancer With FGFR2 Gene Fusion Eisai Co., Ltd. has officially submitted a request for marketing authorization in Japan for tasurgratinib succinate, its internally developed tyrosine kinase inhibitor tar...

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MedTech News for Laminar, BD, Vivos, Zilia, Penumbra
Johnson & Johnson Medtech Acquired Laminar; BD Launched Advanced Vascular Access Ultrasound System; FDA Cleared Oral Device for Severe Sleep Apnea; FDA Clearanced the Zilia OcularTM FC Retinal Camera; First Patient Enrolled in Penumbra Study of Computer-assisted Vacuum Thrombectomy; US FDA Granted the BiVACOR Total Artificial Heart IDE Approval for First-in-Human Early Feasibility Study

FDA Cleared Oral Device for Severe Sleep Apnea From Vivos Therapeutics On November 29, 2023, Vivos Therapeutics announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Vivos’s removable CARE (Complete Airway Repositioning and Expansion) oral appliances developed for treat...

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Pharma News for Merck, Roche, AbbVie, Abbisko Pfizer
FDA Grants Priority Review to Merck’s Application for KEYTRUDA Plus Padcev; Roche and Carmot Therapeutics’s Definitive Merger Agreement; AbbVie to Acquire ImmunoGen; FDA Grants Orphan Drug Designation to LP-284; Merck Announces Commercialization Agreement With Abbisko; Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial

FDA Grants Priority Review to Merck’s Application for KEYTRUDA Plus Padcev for the First-Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Merck, operating as MSD internationally, reported that the U.S. Food and Drug Administration (FDA) has prioritized the review of a supplementar...

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MedTech News for Ethicon, Medtronic, Surmodics, GSK
Ethicon’s ETHIZIA Hemostatic Sealing Patch; FDA Approves Medtronic’s Minimally Invasive Device to Treat Hypertension; Boston Scientific Acquires Relievant Medsystems; AstraZeneca Launched Evinova; Surmodics Announced Data of the SWING Trial; GSK Advancing the Low Carbon Ventolin Program to Phase III Trials

Ethicon Announced European Approval and Introduction of ETHIZIA™ Hemostatic Sealing Patch Used to Stop Disruptive Bleeding On November 15, 2023, Ethicon, a Johnson & Johnson MedTech company, received approval for ETHIZIA™, an adjunctive hemostat solution that has been clinically proven to achieve sustained h...

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MedTech News for Samsung, Lunit, Vivasure
GE Healthcare and Masimo Announced Collaboration; Samsung Launched New Ultrasound System ‘V6’; MONARCH Platform Approved for Bronchoscopy in China; Lunit Received FDA Nod for Lunit INSIGHT DBT; Route 92 Medical Releases Tenzing Technology Clinical Findings; Vivasure Medical Enrolled 100th Patient for its Vivasure PerQseal Closure Device System Study

GE HealthCare and Masimo Collaborated on Patient Monitoring Tech On November 8, 2023, GE HealthCare and Masimo announced a joint agreement to integrate patient monitoring technologies.  The goal of the partnership is to incorporate Masimo Signal Extraction Technology (SET) pulse oximetry into GE HealthCa...

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Pharma News for Bayer, Merck, Ayala, GARDP, AstraZeneca
New Asundexian Phase III Study Result; Zibotentan/Dapagliflozin Combination Demonstrated Significant Albuminuria Reduction Chronic Kidney Disease; Orphan Drug Designation to Rhenium Obisbemeda; FDA Approves Merck’s KEYTRUDA Plus Gemcitabine and Cisplatin for Biliary Tract Cancer; Orphan Drug Designation to Ayala’s AL102; GARDP Announces Successful Phase 3 Trial of of Uncomplicated Gonorrhea

Positive Results Announced in Largest Pivotal Phase 3 Trial of a First-in-Class Oral Antibiotic to Treat Uncomplicated Gonorrhea The Global Antibiotic Research & Development Partnership (GARDP), in partnership with Innoviva, Inc. (Nasdaq: INVA), had announced a significant milestone. They revealed that zolif...

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MedTech News for Laborie, Sirtex, Paige, Neurovalens
Laborie Medical Acquired Urotronic; Sirtex’s LAVA Liquid Embolic System; Paige’s Cancer Detection in Breast Lymph Nodes; FDA Clearance to Neurovalens’s Non-Invasive Insomnia-Treating Device; Recor Medical’s Renal Denervation System; Pulsecare Medical’s nsPFA Clinical Trial Short-term Follow-up Results

Neurovalens Received US FDA Clearance for Non-Invasive Insomnia-Treating Device  On October 30, 2023, Belfast, Northern Ireland-based Neurovalens announced the US Food and Drug Administration clearance for its Modius Sleep device meant for treating chronic insomnia.  Modius has been designed to deli...

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