FDA
Mar 14, 2024
Allumiqs and Prolytix’s Partnership; Setpoint Medical’s Neuroimmune Modulation Platform gets FDA Breakthrough Designation; MangoRx Launches ‘PRIME’ with FDA-approved TRT; SeaStar Medical Updates Quelimmune Commercial Launch; Ventris Medical Gains 510(k) for Amplify® Bone Graft Putty
MangoRx Officially Launches ‘PRIME’ by MangoRx, Powered by Kyzatrex®️ FDA Approved Oral Testosterone Replacement Therapy (TRT) Treatment On March 12, 2024, Mangoceuticals, Inc. unveiled a groundbreaking development eagerly awaited by many: the launch of 'PRIME' by MangoRx, Powered by Kyzatrex®️. This release mar...
Read More...
Mar 12, 2024
BeiGene’s BRUKINSA Gets FDA Accelerated Approval; GSK’s Positive Results in DREAMM-8 Phase III; Sandoz’s Denosumab Biosimilars FDA Approved; Terns Pharma’s TERN-701 Receives Orphan Drug Designation; Wegovy® Approved in US for Overweight Cardiovascular Risk; Travere Therapeutics Submits sNDA for FILSPARI IgAN Full Approval
BeiGene Receives FDA Accelerated Approval for BRUKINSA in Relapsed/Refractory Follicular Lymphoma BeiGene, Ltd., has declared that the FDA has provided accelerated approval for BRUKINSA® (zanubrutinib) to be used in treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), when used alo...
Read More...
Mar 07, 2024
Philips Teamed with SyntheticMR; BioPhotas’s Celluma Light Therapy; Boston Scientific’s AGENTTM Drug-Coated Balloon; Varian’s TrueBeam and Edge Radiotherapy Systems; Carthera’s Brain-Blood Barrier Trial; Prototype Device Effectively Treated Multiorgan Failure
Philips Teamed with SyntheticMR to Deliver Breakthrough AI-based Quantitative Brain Imaging in MR to Advance Neurology Care For Patients On March 01, 2024, Philips in collaboration with SyntheticMR announced the launch of Smart Quant Neuro 3D, a significant advancement in objective decision support for diag...
Read More...
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 ...
Read More...
Feb 29, 2024
Profound Medical and Siemens Entered Into a Collaboration; CardiAI and Carleton University Forged an Innovative Partnership; BrainMD Launched Revolutionary Smart Collagen Supplements; FDA Approved Seastar’s Quelimmune Device; Nebraska-developed Surgical Robot Received FDA Approval; Catheter Precision Presentated First Clinical Data on LockeT
Profound Medical and Siemens Healthineers Entered Into a Collaboration on Ultrasound Ablation On February 27, 2024, Profound Medical entered into a non-exclusive agreement with Siemens Healthineers. The objective of the agreement was to establish the foundation for Profound's commencement of marketing a comprehe...
Read More...
Feb 27, 2024
Survodutide Phase II trial Shows Groundbreaking Results in Liver Disease; GSK Announces Positive Headline Results from EAGLE-1 Phase III Trial; Dupixent sBLA Accepted for FDA Priority Review; Biogen’s QALSODY Received Positive Opinion from CHMP; FDA Granted Orphan Drug Designation to Immune-Onc’s IO-202; Artiva Biotherapeutics’s AlloNK® in Lupus Nephritis
Survodutide Phase II trial Shows Groundbreaking Results in Liver Disease due to MASH, with Significant Improvements in Fibrosis Boehringer Ingelheim has reported that in a Phase II trial, a significant proportion of adults treated with survodutide (BI 456906), up to 83.0%, showed a notable enhancement in metabol...
Read More...
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...
Read More...
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...
Read More...
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...
Read More...
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...
Read More...
-Agonist.png "Toll-like Receptors Agonist")
