Oncology Highlights – 30/07/2018
Oncology Highlights – 30/07/2018
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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Apyx Medical Received FDA 510(k) Clearance for ...

Apyx Medical Corporation Received FDA 510(k) Clearance for the Use of Renuvion® for Coagulation of Subcutaneous Soft Tissues Following Liposuction for Aesthetic Body Contouring On April 28, 2023, A...

May 04, 2023

MedTech News and Updates for Apyx, Medtronic, Vivasure, SunMed, Eitan Medical, Concept Medical, Vyaire Medical
pharma-news-for-bms-teva-biogen-atsena-kiromic
FDA Grants Priority Review to BMS’ Luspatercept; Teva and MedinCell’s Risperidone FDA Approval; Biogens’s QALSODY FDA Accelerated Approval; FDA IND Authorization to Kiromic’s Deltacel; Atsena’s ATSN-201 FDA IND Clearance

FDA Grants Priority Review to Luspatercept for First-line Treatment of Anemia in Lower-risk MDS The FDA has granted priority review to a supplemental biologics license application (sBLA) seeking to expand the current indication of luspatercept-aamt (Reblozyl) to include treatment of anemia in patients with very ...

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MedTech News and Update GE HealthCare, Medtronic, Nevro, Syntr Health Technologies, Devyser + Thermo Fisher Scientific, Smith+Nephew
GE HealthCare’s CARESCAPE Canvas Patient Monitoring Platform; Medtronic’s MiniMed™ 780G System; Nevro Enroll’s First Patient in PDN Sensory Study; Syntr Health Presents Data from Facial Fat Transfer Clinical Study; Devyser-Thermo Fisher Scientific Signs Agreement; Smith+Nephew Introduced Digital Tensioning Device

GE HealthCare’s CARESCAPE Canvas Patient Monitoring Platform Received FDA Clearance  On April 20, 2023, GE HealthCare, a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, received the US FDA 510(k) clearance for its CARESCAPE Canvas patient monitoring platform f...

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Pharma News for XORTX, Roche, Lantheus, Janssen, Daiichi Sankyo, bluebird bio, and POINT Biopharma Global
Janssen’s AKEEGA Approval; FDA Approves Roche’s Polivy Combo for Frontline B-cell Lymphoma; Daiichi Sankyo’s Quizartinib for Adults With FLT3-ITD-Positive AML; bluebird bio BLA for lovo-cel for Patients with Sickle Cell Disease; Fast Track Designation for Lu-PNT2002 for mCRPC Treatment; FDA Orphan Drug Designation to XORTX’s Oxypurinol

Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) had granted marketing authorization for AKEEGA® (niraparib and abiraterone acetate [AA]), in the form...

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More Views & Analysis

MedTech News for Bausch + Lomb, Heidelberg Engineering, Oxford Nanopore, bioMérieux, Senseonics, Boomerang Medical, RapidAI, Neuspera Medical
Bausch + Lomb and Heidelberg Engineering Introduced SeeLuma; Oxford Nanopore and bioMérieux Signs Partnership Agreement; Boomerang Medical’s Bioelectronic Device for Inflammatory Bowel Disease; Senseonics’s ENHANCE Clinical Trial Updates; RapidAI’s Non-Contrast CT Imaging Product; FDA Clearance for Neuspera Medical’s Peripheral Nerve Stimulation System

Bausch + Lomb and Heidelberg Engineering Introduced SeeLuma™ Fully Digital Surgical Visualization Platform  On April 13, 2023, Bausch + Lomb, a leading global eye health company dedicated to helping people see better and to live better, and Heidelberg Engineering, announced the introduction of the Se...

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Pharma News and Updates for RegeneRx, Aldeyra, Oncolyze, Soligenix, Aviceda
RegeneRx’s Phase 3 Neurotrophic Keratitis Clinical Trial of RGN-259; Aldeyra’s Phase 3 INVIGORATE-2 Clinical Trial Update; FDA Orphan Drug Designation to Oncolyze’s OM-301 for Multiple Myeloma; Soligenix Provides Regulatory Update on HyBryte; FDA Fast Track Designation to SAB Biotherapeutics’s SAB-176 Influenza Immunotherapy; Aviceda IND Application for AVD-104

RegeneRx Biopharmaceuticals Enrolled First Patient in the Phase 3 Neurotrophic Keratitis Clinical Trial with RGN-259 in the US On April 12, 2023, RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx" or "Company") announced that the first patient of Phase 3 clinical trial (SEER-2) of RGN-259, a novel treat...

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MedTech News for BD, Icentia, Bone Biologics, Compal Electronics, Avation Medical, Cardiovascular Systems
BD’s Advanced Ultrasound Technology for IV Insertions; Compal Electronics Launched New RFA System AblatePal; Icentia Received Clearance for CardioSTAT; Avation Medical Announced Clearance for the Vivally® System; Cardiovascular Systems’s ECLIPSE Clinical Trial; Bone Biologics Received Approval to for Pilot Trial with NB1 in Spinal Fusion Patients

BD Introduced Advanced Ultrasound Technology for IV Insertions to Help Drive First-Stick Success On April 11, 2023, BD (Becton, Dickinson, and Company), a leading global medical technology company, announced the launch of a new, easy-to-use advanced ultrasound device with a specialized probe designed to provide ...

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Pharma News and Updates for Cingulate, Merck, Transcenta, Ipsen, Nuance
Ipsen’s Cabometyx Rejected by NICE; Vertex and CRISPR Therapeutics’s Submit BLA to the FDA for exa-cel; Orphan Drug Designation to Osemitamab for Pancreatic Cancer; FDA Clears Keytruda/Padcev for Bladder and Urothelial Cancer; Cingulate Completes Trial of CTx-1301 for ADHD; Nuance Pharma Announces Dosing of First Patient in ENHANCE Trial

FDA Grants Orphan Drug Designation to Osemitamab for Pancreatic Cancer Transcenta Holding Limited has announced that the U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designation to Osemitamab (TST001), a highly potent humanized monoclonal antibody that enhances ADCC (antibody-dependent cell-me...

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MedTech News for Laborie, Cadwell, Endotronix, Sonex Health, Leica Biosystems, Abbott
Laborie Launched alpHaONE; Cadwell Launched Arc Voyager; Endotronix’s PROACTIVE-HF Pivotal Trial; Sonex Health’s Office-based Carpal Tunnel Release System with Ultrasound Guidance; Leica Biosystems’s BOND MMR Antibody Panel; Abbott Received FDA Approval for Epic™ Max Tissue Valve

Sonex Health Announced US Clinical Study to Report Safety and Effectiveness of Office-based Carpal Tunnel Release System with Ultrasound Guidance  On March 30 2023, Sonex Health, Inc., a leader in innovative ultrasound guided therapies to treat common orthopaedic conditions and The Institute of Advanced Ult...

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Pharma News and updates for HUTCHMED, Cytokinetics, Astellas, Seagen, Nanoscope Therapeutics, Cabaletta Bio, Decibel Therapeutics
HUTCHMED’s NDA Submission to FDA for Fruquintinib; Cytokinetics to Discontinue ALS Drug Candidate Following Phase III Trial Failure; Enfortumab Vedotin + Pembrolizumab Approved for Urothelial Carcinoma; Nanoscope Gene Therapy Clears Phase II Retinitis Pigmentosa Trial; FDA Clearance to Cabaletta Bio’s IND Application for CABA-201 for SLE Treatment; European Orphan Drug Designation to Gene Therapy Candidate DB-OTO

HUTCHMED Completes Rolling Submission of NDA to FDA for Fruquintinib HUTCHMED (China) Limited announced the completion of the rolling submission of a New Drug Application ("NDA") to the United States Food and Drug Administration ("FDA") for fruquintinib, its highly selective and potent oral inhibitor of VEGFR-1,...

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With worldwide dissemination and now over 9 million cases and nearly 500,000 deaths recorded, the ef.....

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An autoimmune disease in which the immune system attacks its healthy skin, Cutaneous Lupus Erythemat.....

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A rare autosomal recessive disorder, Familial chylomicronemia syndrome (FCS), affects 1 in 1 to 2 mi.....

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Digital health technologies can fill the current gaps in oncology care while rebalancing the existin.....

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Myocardial infarction (MI), colloquially known as “heart attack” is caused by decreased or compl.....

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Though Covid-19 has a significant impact on the supply chain, input costs, logistics, and raw materi.....

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