news
Aug 23, 2022
EMA to review Cidara Therapeutics’ Rezafungin; EU Approves Gilead Sciences’ Sunlenca; FDA Approves Axsome’s Auvelity; EU Marketing Authorisation to Oncopeptides’s Pepaxti; Merck Signs $ 3.5 B Deal with Orna; FDA to review AstraZeneca and Merck’s Lynparza; FDA Approval to Bluebird’s Zynteglo; FDA Decision Date for GSK’s Momelotinib
EU Regulator Starts its Review of Cidara Therapeutics’ Candidiasis Therapy Rezafungin The EU regulator has begun its review of Cidara Therapeutics’ once-weekly antifungal rezafungin, with a decision expected next year as a new option for serious, invasive candida infections. The application is based on the ReSTO...
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Aug 18, 2022
CereVasc’s eShunt System Study; FDA Approves NGS-Based CDx for Trastuzumab Deruxtecan; Nanopath Secures $10 Million Funding; BD, Accelerate Diagnostics Announce Collaboration; Avails Medical’s Clinical Trials for eQUANT; Movano Ring Exceeds Accuracy Targets for SpO2 & Heart Rate Monitoring
CereVasc Announces FDA Approval of Second IDE Study of the eShunt® System On August 09, 2022, CereVasc, Inc., a privately held, clinical-stage medical device company developing novel, minimally invasive treatments for neurological diseases, announced that the U.S. Food and Drug Administration (FDA) has approved ...
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Aug 16, 2022
Novartis’ Canakinumab for NSCLC; Novartis’s Zolgensma Updates; Trodelvy Prospects in New Breast Cancer Use; Novartis Secures European Approval For Pluvicto; Bristol-Myers Squibb’s Abecma Phase III Trials; Trastuzumab Approved for Deruxtecan for HER2-Mutant NSCLC
Novartis’ Canakinumab Fails in Phase III Trials for NSCLC Canakinumab's prospects as an anticancer therapy were already dwindling when a third phase III trial in non-small cell lung cancer (NSCLC) failed to reach its objectives. The most recent setback came from the CANOPY-A study, which included patients with N...
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Aug 11, 2022
Rapid Medical’s TIGERTRIEVER 13; Glaukos’s Istent Infinite System; GE Healthcare’s Definium 656 HD; NeuroOne’s Signed Exclusive Development & Distribution Agreement with Zimmer; Kaia Health’s Rise-uP Randomized Controlled Trial; Bluejay’s Symphony IL-6 Test
Rapid Medical Obtains FDA Clearance for the World's Smallest and Only Adjustable Thrombectomy Device On July 26, 2022, Rapid Medical, a leading developer of advanced neurovascular devices, received Food and Drug Administration (FDA) 510(k) clearance for TIGERTRIEVER™13 for large vessel occlusions.&n...
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Aug 04, 2022
FDA Clearance to iRhythm’s ZEUS System; Respiri Introduces the Wheezo Device & App; CONMED to Acquire Biorez for $ 85 Million; FDA Clearance to Ambu’s Single-Use Bronchoscope; FDA 510(k) Clearance to Glaukos’s iStent infinite
iRhythm receives FDA clearance for ZEUS System for Zio watch iRhythm Technologies, a leading digital healthcare solutions firm focused on advancing cardiac care, announced that it received FDA 510(k) clearance for the ZEUS (Zio ECG Utilization Software) System for the Zio Watch. It is produced in partnership wit...
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Aug 02, 2022
Bristol-Myers Squibb’s Opdivo & Yervoy Combo Trial; Sarepta’s Gene Therapy SRP-9001 for DMD; Ionis’s End-Stage Renal Disease Drugs; FDA Approves Arcutis’s Zoryve Cream; Gilead’s Biktarvy for HIV and Hepatitis B; FDA to Review Biogen’s ALS Therapy Tofersen
Bristol-Myers Squibb’s Opdivo and Yervoy Combo Fails in Phase III Trial Bristol-Myers Squibb has reported that their Opdivo and Yervoy checkpoint inhibitor combo failed a phase III trial as adjuvant (post-surgery) therapy for renal cell carcinoma (RCC), the most frequent type of kidney cancer. The CheckMate -914...
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Jul 28, 2022
AbbVie & iSTAR’S Strategic Alliance; Baxter Launches Welch Allyn RetinaVue 100 Imager PRO; Instylla’S Embrace Hydrogel Embolic System; Primary Endpoint Met in the RADIANCE II US Trial; Roche’s Elecsys Amyloid Plasma Panel; EU Approval to Seegene’s Allplex; SARS-CoV-2/FluA/FluB/RSV Assay
ReCor Medical and Otsuka Medical Devices Announce Primary Endpoint Met in the RADIANCE II US Pivotal Trial of the Paradise™ System for the Treatment of Hypertension On July 26, 2022, ReCor Medical, Inc., a completely owned subsidiary of Otsuka Medical Devices Co., Ltd., with its headquarters in Palo Alto,...
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Jul 12, 2022
Novo Nordisk’s Concizumab for Hemophilia; AbbVie Ends its Alliance with Alector; ADC Therapeutics and Sobi Enters in Exclusive Licensing Deal; BMS’ Opdivo Gets NHS Use; Merck to Acquire Seagen; FDA Priority Review to Roche’s Lunsumio; AstraZeneca to Acquire TeneoTwo; FDA Orphan Drug Designation to PBI-200
Novo Nordisk Reports Phase III Results of Concizumab Drug for Hemophilia A or B Novo Nordisk has announced Phase III results for their concizumab drug for hemophilia A or B, demonstrating efficacy in preventing bleeding events and paving the way for regulatory filings later this year. Concizumab, an anti-tissue ...
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Jul 07, 2022
Collagen Matrix FDA 510(k) approval for Fibrillar Collagen Wound Dressing; Roche’s cancer diagnostics ULTRA PLUS system launch; Insightec IDE Approval for Prostate Cancer; JustLight plc. trial of Sunflower Rx for Alzheimer’s disease; Thoraflex Hybrid Device Implantation in the United States; FDA 510(k) Clearance for the DABRA 2.0 Catheter
Collagen Matrix received FDA 510(k) approval for Fibrillar Collagen Wound Dressing On June 29, 2022, Collagen Matrix, Inc., a leader in regenerative medicine, a global manufacturer of collagen and other biomaterial-based medical devices, and Linden Capital Partners portfolio company announced FDA 510(k) Clearan...
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Jun 23, 2022
CE Mark to Ibex’s Gastric Cancer Detection System; Senseonics’s Eversense E3 Continuous Glucose Monitoring System; NEUSPERA’s NUVELLA SYSTEM; Conformal Medical Initiates CONFORM Pivotal Trial; Meridian Launches New qPCR Master Mixes for Stool Samples; Sentinel Diagnostics Launches SENTiFIT 800
Conformal Medical Announces Launch of CONFORM Pivotal Trial On June 17, 2022, Conformal Medical Inc, is a medical device company manufacturing devices to avoid strokes in patients with non-valvular atrial fibrillation and developing next-generation LAAO technology. Its exclusive technology is intended to make le...
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