news
May 02, 2023
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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Apr 27, 2023
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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Apr 25, 2023
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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Apr 18, 2023
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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Apr 13, 2023
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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Apr 11, 2023
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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Mar 30, 2023
Mindray’s TE Air Handheld Ultrasound System; Getinge’s iCast™ Covered Stent System; Clinical Trial Update for the FLASH Proton Therapy for Cancers in the Bones; Gore’s Gore® Viafort Vascular Stent IVC Study; CoreLink’s Siber® Ti—3D Printed SI Joint Fusion System; USound and Partners’s Next-Generation Over-the-Counter Hearing Aids
TE Air Handheld Ultrasound System Launched by Mindray On March 16, 2023, Mindray, a China-based company announced the launch of TE Air, a high-quality, wireless, handheld, portable ultrasound device that is designed to easily fit into a pocket. Built with Mindray’s eWave platform and second-generation S...
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Mar 28, 2023
Novartis Announces the Positive Results of Phase III NATALEE Trial Evaluating Kisqali; FDA Approves Pharming’s Joenja for APDS; FDA Orphan Drug Designation to Cyclerion’s Zagociguat; Iovance Completes BLA Submission for Lifileucel in Advanced Melanoma; BPGbio Announces Partnership with debra of America
Novartis Announces the Positive Results of Phase III NATALEE trial Evaluating Kisqali Novartis announced positive topline results from an interim analysis of NATALEE, a Phase III trial evaluating Kisqali® (ribociclib) plus endocrine therapy (ET) in a broad population of patients with hormone receptor-positive/hu...
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Mar 23, 2023
Viz.ai’s AI Algorithm for Abdominal Aortic Aneurysm; BrainTale Unveils the New Version of Its Digital Biomarkers Platform brainTale-care; Medtronic and NVIDIA Announces Collaboration; Median Technologies Announces Update for its iBiopsy Lung Cancer Screening CADe/CADx Software as Medical Device
Viz.ai is First to Receive FDA 510(k) Clearance for AI Algorithm for Abdominal Aortic Aneurysm On March 21, 2023, Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, announced it had received U.S. Food and Drug Administration (FDA) 510(k) clearance for its algorithm intended to ...
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Mar 21, 2023
AbbVie Announces Results of Study Evaluating SKYRIZI; FDA Fast Track Designation to Arrowhead’s ARO-APOC3; FDA Approves Dabrafenib Plus Trametinib for BRAF V600E–Mutated Low-Grade Glioma; FDA Grants ODD to Novel BRAF Inhibitor for Brain/CNS Malignancies; EP0042 Wins FDA Orphan Drug Status; Karuna Therapeutics Announces Results from Phase 3 EMERGENT-3 Trial of KarXT in Schizophrenia
AbbVie Announces Positive Results of Study Evaluating SKYRIZI in Plaque Psoriasis Patients AbbVie announced new 52-week data from an open-label, a single-arm study demonstrating improved plaque psoriasis signs and symptoms in a difficult-to-treat patient population who received SKYRIZI® (risankizumab), an IL-23 ...
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