FDA
May 02, 2024
Xtant Medical’s SimipliGraft TM and SimpliMaxTM Launch; Perelel’s Fertility Support Products Expansion; Medtronic’s InceptivTM FDA Approval; GE Healthcare’s Vital Signs Monitor FDA 510(K) Clearance; Merck’s Pneumonia Vaccine Positive Results; Artivion’s Aortic Devices AATS Win
Xtant Medical Announced the Launch of SimipliGraft TM and SimpliMaxTM for Chronic and Acute Wounds On April 30, 2024, Xtant Medical Holdings, Inc., a global medical technology firm specializing in surgical remedies for spinal disorders, announced the complete commercial availability of two amniotic membran...
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Apr 30, 2024
X4 Pharmaceuticals’ XOLREMDI FDA Approval; ONO to Acquire Deciphera Pharmaceuticals; Johnson & Johnson’s SIRTURO CHMP Approval; BeiGene’s Tislelizumab EC Approval; Sanofi’s Rilzabrutinib LUNA 3 Phase III Trial
FDA Greenlights XOLREMDI Capsules from X4 Pharmaceuticals for WHIM Syndrome Treatment X4 Pharmaceuticals has declared that the FDA has granted approval for XOLREMDI™ (mavorixafor) capsules to be utilized in individuals aged 12 and above who have WHIM syndrome (characterized by warts, hypogammaglobulinemia, infec...
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Apr 25, 2024
iVEAcare’s $27.5 Million Series A Funding; AI Medical Service Joint Research Agreement with Mahidol University; CERENOVUS Launched Catheter; Cochlear FDA Clearance for The Osia System; Immunovia Announced Positive Results From The Model-Development Study; Hyalex Orthopaedics First Patients Treatment
iVEAcare Launched $27.5 Million Series A Funding from Leading Medtech Investors On April 24, 2024, iVEAcare, announced the closure of a $27.5 million Series A financing. The financing was led by Vensana Capital, which was joined by Treo Ventures, Hatteras Venture Partners, and an undisclosed strategic partner. i...
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Apr 23, 2024
Ipsen and Skyhawk Therapeutics Partnership; SynOx Therapeutics’ Phase III Trial; Roche’s Alecensa FDA Approval; AbbVie’s RINVOQ Phase III SELECT-GCA Trial; AskBio’s AB-1002 FDA Fast Track Designation
Ipsen Partners with Skyhawk Therapeutics for RNA-Focused Research in Rare Neurological Disorders Ipsen and Skyhawk Therapeutics have entered into an exclusive global partnership to explore and create new small molecules that can influence RNA for rare neurological conditions. Under this agreement, Ipsen has the ...
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Apr 18, 2024
Baxter Introduced New Injectable Pharmaceuticals to US Market; Bayer and Hologic Collaborated to Deliver Contrast-Enhanced Mammography; Labcorp Received FDA Emergency Use Authorization for Mpox PCR Test Home Collection Kit; Onkos Surgical Won FDA De Novo Nod For Antibacterial-Coated Orthopedic Implants; Heartbeam Presented Positive Results On Its Artificial Intelligence Capabilities For Detecting Arrhythmias; Cognito Therapeutics Showed Positive Non-Invasive Neuromod Results
Baxter Introduced New Injectable Pharmaceuticals to US Market On April 11, 2024, the pharmaceutical portfolio of multinational medical goods corporation Baxter International Inc. was augmented with the introduction of five new injectable medications in the US market. The goods were made to fulfill essential dema...
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Apr 16, 2024
Roche’s Columvi Phase III STARGLO Trial; Novartis’ Fabhalta Latest Data; Vertex’s Alpine Immune Sciences Acquisition; Telix Pharmaceuticals’ TLX101-CDx Fast Track Designation; NovelMed’s NM5072 Orphan Drug Designation
Roche's Columvi Achieves Primary Endpoint of Prolonged Overall Survival in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma in Phase III STARGLO Trial Roche reported that the Phase III STARGLO trial successfully achieved its main goal of improving overall survival. The research revealed that in...
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Apr 11, 2024
Carl Zeiss Meditec AG’s Acquisition of Dutch Ophthalmic Research Center; Johnson & Johnson’s Shockwave Medical Acquisition; Biora Therapeutics’ BT-600 Positive Results; Medtronic’s Single-Shot Mapping Ablation Catheter Positive Data; Abbott’s TriClip FDA Approval; Abbott’s Whole Blood Rapid Test FDA Clearance
Carl Zeiss Meditec AG Completed Acquisition of Dutch Ophthalmic Research Center (D.O.R.C); Companies Unite to Shape Ophthalmology Market On April 04, 2024, Carl Zeiss Meditec AG announced that it acquired D.O.R.C. (Dutch Ophthalmic Research Center) from the investment firm Eurazeo SE, Paris, France. T...
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Apr 09, 2024
AstraZeneca and Daiichi Sankyo’s Enhertu US Approval; Basilea’s ZEVTERA FDA Approval; Genmab’s ProfoundBio Acquisition; Rocket Pharmaceuticals’ RP-L102 EMA Approval; Alexion’s Ultomiris and Soliris AAN 2024 Data
Enhertu Receives US Approval as First HER2-focused Treatment for Metastatic Solid Tumors, Independent of Tumor Origin AstraZeneca and Daiichi Sankyo's drug Enhertu (trastuzumab deruxtecan) has gained approval in the United States for treating adult patients with inoperable or metastatic HER2-positive (IHC 3+) so...
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Apr 04, 2024
C2Dx’s Shaw Scalpel System; Texas Original’s RSO Gummies; Abbott’s Whole Blood Rapid Test FDA Clearance; Medtronic’s TAVR Device FDA Clearance; Nexalin’s Device Improved Symptoms; CYduct Diagnostics’ Positive Study Results
C2Dx Launched Next Generation Shaw Scalpel System On March 26, 2024, C2Dx, a privately-owned medical device company, announced the launch of its Next Generation Shaw Scalpel System. The Shaw Scalpel System has obtained 510(k) clearance from the FDA for the upgraded controller of its advanced surgical techn...
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Apr 02, 2024
AstraZeneca’s Voydeya FDA Approval; Akebia’s Vafseo FDA Approval; Bristol Myers Squibb’s Phase III YELLOWSTONE Trial Update; Astellas’ IZERVAY FDA Approval; AstraZeneca’s Truqap and Faslodex MHLW Approval
Voydeya Receives FDA Approval as Supplemental Treatment with Ravulizumab or Eculizumab for Managing Extravascular Hemolysis in Adult Patients with PNH Voydeya (danicopan) has received approval in the United States for use alongside ravulizumab or eculizumab in treating extravascular hemolysis (EVH) in adults dia...
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