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Thursday, July 3, 2025

Tag: FDA

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Robotic Surgery Market 2025 Trends: Advanced AI Systems, Telesurgery and $400M Investments Power Global Expansion

The global robotic surgery market size is calculated at USD 13.79 billion in 2025 and is expected to reach around USD 54.66 billion by 2034, growing at a CAGR of 16.54% for the forecasted period. 
The global robotic surgery market size is calculated at USD 13.79 billion in 2025 and is expected to reach around USD 54.66 billion by 2034, growing at a CAGR of 16.54% for the forecasted period.

Clearmind Medicine Announces IRB Approval for Phase 1/2a Clinical Trial for Alcohol Use Disorder at Tel Aviv Sourasky Medical Center

Vancouver, Canada, July 03, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced that it has received Institutional Review Board (IRB) approval from Tel Aviv Sourasky Medical Center (TASMC) in Tel Aviv, Israel, for its ongoing Phase 1/2a clinical trial evaluating CMND-100, a proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD). This approval will enable patient enrollment at TASMC, a leading clinical site in Israel, prior to commencing this first-in-human trial at the site.

Dizal’s ZEGFROVY® (sunvozertinib) Receives FDA Accelerated Approval as the Only Targeted Oral Treatment for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

ZEGFROVY is the only approved targeted oral treatment for NSCLC with EGFR exon20insApproval follows the U.S. FDA's Priority Review and is supported by the pivotal WU-KONG1 Part B study, in which...

Sleep Apnea Market to Accelerate Substantially at a CAGR of 20% During the Study Period (2020-2034) | DelveInsight

The sleep apnea market growth is driven by rising awareness, technological advancements, and demand for personalized care. Companies innovate therapies and solutions for better...

SeaStar Medical Announces Positive Nasdaq Listing Determination

DENVER, July 02, 2025 (GLOBE NEWSWIRE) -- Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced today that it has received confirmation from The Nasdaq Stock Market that the Company has evidenced compliance with the minimum $2.5 million stockholders’ equity requirement and all other applicable criteria for continued listing on The Nasdaq Capital Market. Accordingly, the previously disclosed listing matter has been closed.

Lynozyfic™ (linvoseltamab-gcpt) Receives FDA Accelerated Approval for Treatment of Relapsed or Refractory Multiple Myeloma

Lynozyfic is a bispecific antibody directing T cells to kill multiple myeloma cancer cells; multiple myeloma is the second most common blood cancer 

Innophos Launches Clean-Label Whitening Alternative to Titanium Dioxide

Following FDA Approval of Calcium Phosphate as a Color Additive in Select Foods CRANBURY, N.J., July 2, 2025 /PRNewswire/ -- Innophos, a leading innovator in...

Marengo Presents Monotherapy Activity of Invikafusp Alfa, a First-in-Class Selective Dual T Cell Agonist in PD-1 Resistant GI Tumors, as a Late-Breaking Oral Presentation...

Promising monotherapy activity observed in all three major metastatic colorectal cancer subtypes harboring high tumor mutational burden (MSS RASwt, MSS RASmut and PD-1 resistant MSI-H)...

Corlines kund Kardium genomför finansiering om 250 miljoner USD för lanseringen av Globe®

Kanadensiska Kardium meddelade under dagen att man genomfört en kapitalrekrytering om 250 miljoner USD för att stödja global kommersialisering av Globe® Pulsed Field System – en banbrytande plattform för behandling av förmaksflimmer med hjälp av behandlingstekniken pulsed field ablation (PFA). Den nu kommunicerade investeringen innebär att Kardium sammantaget attraherat över 350 miljoner USD från externa investerare under de senaste dryga tolv månaderna, vilket tillhör det absoluta toppskiktet i den nordamerikanska medicinteknikindustrin.

X-Therma Showcases Groundbreaking Organ Preservation Technology at Johns Hopkins’ “Hopkins on the Hill” Event

HERCULES, Calif., July 2, 2025 /PRNewswire/ -- X-Therma Inc., a pioneering biotechnology company revolutionizing organ preservation and regenerative medicine, proudly announces its participation in...

2 Day Pharmaceutical, Biopharmaceutical, Biologics and Medical Device FDA Inspection Preparedness and Compliance Seminar (ONLINE EVENT: September 3-4, 2025)

Join our two-day seminar designed for pharmaceutical, biopharmaceutical, biologics, and medical device professionals to master FDA inspections. Gain hands-on strategies to efficiently prepare, conduct, and respond. Includes slides, certificates, Q&A, and inspection handouts. Optimize outcomes. 
Join our two-day seminar designed for pharmaceutical, biopharmaceutical, biologics, and medical device professionals to master FDA inspections. Gain hands-on strategies to efficiently prepare, conduct, and respond. Includes slides, certificates, Q&A, and inspection handouts. Optimize outcomes.

Invivyd and Leading Researchers Form SPEAR (Spike Protein Elimination and Recovery) Study Group to Assess the Effects of Monoclonal Antibody Therapy for Long COVID...

Invivyd Forms SPEAR (Spike Protein Elimination and Recovery) Study Group with Researches to Assess Effects of Monoclonal Antibody Therapy for Long COVID

Everest Medicines Announces Updated Positive Results in Preliminary Analysis of Phase 1b/2a Clinical Trial of EVER001, a Novel BTK Inhibitor for the Treatment of...

As of March 21st, 2025, longer follow-up data was collected from the ongoing Ph1b/2a study of EVER001: in Cohort 1, 11 patients completed 52...

Belite Bio Announces Completion of Enrollment in the Pivotal Global Phase 3 PHOENIX Trial Evaluating Oral Tinlarebant in Geographic Atrophy

-  500 subjects enrolled across the United States, the United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia

- A word from our sponsors -

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