news
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 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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Mar 26, 2024
Regeneron’s Odronextamab BLA; Novo Nordisk’s Cardior Pharmaceuticals Acquisition; Novartis’ Fabhalta CHMP Approval; Idorsia’s TRYVIO FDA Approval; AbbVie’s Landos Biopharma Acquisition
Regeneron Updates Progress on Biologics License Application for Odronextamab Regeneron Pharmaceuticals, Inc. has announced that the FDA has issued Complete Response Letters (CRLs) regarding the Biologics License Application (BLA) for odronextamab in cases of relapsed/refractory (R/R) follicular lymphoma (FL) and...
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Mar 05, 2024
Bayer’s New Cardiology Drug Acoramidis; Two Datopotamab Deruxtecan Applications Validated in the EU; AbbVie and OSE Immunotherapeutics Announce Announces Partnership; vTv Therapeutics Makes Major Move With Cadisegliatin; A2 Bio Scores FDA Orphan Drug Designation for its Therapy, A2B530; FDA Fast Track Designation for AlloNK® in Lupus Nephritis
Acoramidis Joins Bayer's Robust Lineup, Boosting Cardiology Solutions Bayer has obtained the exclusive rights to market acoramidis in Europe from Eidos Therapeutics Inc., BridgeBio International GmbH, and BridgeBio Europe B.V. Acoramidis, a highly potent and selective small molecule given orally, functions as a ...
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Feb 20, 2024
FDA Approves Xolair for Food Allergies; FDA Accelerated Approval for Iovance’s AMTAGVI; Astellas and Kelonia Enter into Research and License Agreement; Fast Track Designation to Certa’s FT011; Innovent Announces Phase 3 Clinical Trial Updates for IBI311; Orphan Drug Designation to Cardiol’s Pericarditis Drug Candidate
FDA Approves Xolair as First and Only Medicine for Children and Adults with One or More Food Allergies Roche has announced that the FDA has approved Xolair® (omalizumab) to mitigate allergic responses, such as anaphylaxis, that may arise from accidental exposure to various foods in both adult and pediatric patie...
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Feb 15, 2024
Tandem’s Automated Insulin Patch Pump; ResMed’s Bilevel Sleep Respiratory Devices; Masimo’s First Over-The-Counter Fingertip Pulse Oximeter; Viz.Ai Algorithm for Quantifying Intracerebral Hemorrhage; Canary Medical’s Heart Sound Monitor; UroMems’ Smart Urinary Sphincter System
Tandem Diabetes Care Launched Mobi Mini Automated Insulin Patch Pump On February 13, 2024, announced that it started off the U.S. commercial launch of its Mobi insulin patch pump. The San Diego-based business claims that Mobi, which is fully controllable via a smartphone app, is the world's smallest durable a...
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Feb 13, 2024
GSK Receives FDA Fast Track Designation for Bepirovirsen; Gilead to Acquire CymaBay Therapeutics; CSL Announces Top-line Results from the Phase III AEGIS-II Trial; Ruxoprubart Scores FDA Orphan Drug Designation for PNH Treatment; CymaBay Announces FDA Acceptance of NDA and Priority Review for Seladelpar; Biogen Received European Commission Approval for SKYCLARYS
GSK Receives FDA Fast Track Designation for Bepirovirsen in Chronic Hepatitis B GSK plc has revealed that the US Food and Drug Administration (FDA) has awarded Fast Track status to bepirovirsen, an experimental antisense oligonucleotide (ASO) designed to treat chronic hepatitis B (CHB). Fast Track designation ai...
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Feb 07, 2024
Navigating the Healthcare Horizon: Odyssey of Mergers, Funding, and Acquisitions in 2024
As we step into the crisp corridors of 2024, the healthcare landscape unfolds a compelling saga of mergers, strategic funding, and transformative acquisitions. In this month-by-month analysis, we delve into the intricate tapestry of industry dynamics, exploring the impactful maneuvers that are shaping the healthcar...
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Feb 06, 2024
4DMT Presents Data From Phase II PRISM Clinical Trial; Adaptimmune Announces FDA Acceptance of Biologics License Application for Afami-cel; Astellas Submits Supplemental New Drug Application in Japan for PADCEV with KEYTRUDA; AnaMar Announces US and EU Orphan Drug Designation for AM1476; Biosyngen Announces FDA Fast Track Designation for BST02; Acepodia Announces FDA Clearance of IND Application for ACE2016
4DMT Presents Positive Interim Data from Randomized Phase II PRISM Clinical Trial of Intravitreal 4D-150 Demonstrating Favorable Tolerability & Clinical Activity in Wet AMD 4D Molecular Therapeutics, a prominent company in the field of genetic medicines with a focus on harnessing the full potential of geneti...
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