FDA Approves Relacorilant for Ovarian, Fallopian, and Peritoneal Cancer The U.S. Food and Drug Administration approved relacorilant in combination with nab-paclitaxel, offering a new treatment option for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. The approva.. Friday, 27 Mar 2026 Read the story
FDA Approves AVLAYAH, a Milestone in Rare Disease Treatment Denali Therapeutics has received accelerated approval from the U.S. Food and Drug Administration for AVLAYAH™ (tividenofusp alfa-eknm), marking a pivotal advancement in the treatment of Hunter syndrome, a rare genetic disorder that affect.. Thursday, 26 Mar 2026 Read the story
Vertex’s Povetacicept Shows Breakthrough in Treating Kidney Diseases Vertex Pharmaceuticals announced that its experimental kidney disease drug povetacicept reached an important goal in a late-stage clinical trial, greatly increasing hopes for a successful treatment for immunoglobulin A nephropathy (IgAN). T.. Wednesday, 11 Mar 2026 Read the story
FDA Grants Approval to Zongertinib for Advanced Lung Cancer The U.S. Food and Drug Administration approved zongertinib for adults with unresectable or metastatic non-squamous non-small cell lung cancer. This decision expands targeted treatment options for patients whose tumors carry specific HER2 ty.. Monday, 02 Mar 2026 Read the story
FDA Approves BYSANTI™ (milsaperidone) for Bipolar I and Schizophrenia Vanda Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration approved BYSANTI™ (milsaperidone) as a new treatment option for adults diagnosed with bipolar I disorder and schizophrenia. This marks a significant leap forw.. Monday, 23 Feb 2026 Read the story
FDA Clears ACCRUFeR® (ferric maltol) for Iron Deficiency The U.S. Food and Drug Administration has approved ACCRUFeR® (ferric maltol), developed by Shield Therapeutics, as the first and only prescription oral iron therapy for children aged 10 years and older. Previously, ACCRUFeR® has been pres.. Wednesday, 18 Feb 2026 Read the story
Datroway (datopotamab deruxtecan) Earns FDA Priority Review In a major oncology development, the U.S. FDA has accepted a supplemental application for Datroway (datopotamab deruxtecan). It has been granted priority review as a first-line therapy for adults with metastatic triple-negative breast cance.. Tuesday, 17 Feb 2026 Read the story
FDA Labeling Rules Rewrite the Future of Color-Free Foods The FDA announced new measures that make it easier for companies to claim their foods contain no artificial colors. This shift followed industry concerns about outdated definitions and consumer confusion. The agency now allows labels to state the absence of artificia.. Monday, 09 Feb 2026 Read the story
Zongertinib Gains Accelerated FDA Approval as First Oral Targeted Option for HER2-Mutant Lung Cancer Pune, India | August 13, 2025 — The U.S. Food and Drug Administration (FDA) has granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), an oral kinase inhibitor. This new thera.. Tuesday, 26 Aug 2025 Read the story
Zongertinib Gets Accelerated FDA Nod for HER2 NSCLC New York | August 13, 2025- A major shift has occurred in the treatment of a rare, aggressive form of non-small cell lung cancer (N.. Thursday, 14 Aug 2025 Read the story
Global Process Analytical Technology Market: Development History, Current Analysis and Estimated Forecast to 2027 | Perkinelmer, Inc Process Analytical Technology Market research report delivers a comprehensive study on production capacity, consumption, import and export for all major regions across the world. Report provides is a professional inclusive study on the current state for the market. A.. Friday, 12 Feb 2021 Read the story
North America Nutraceuticals Market to Upsurge with an Rise in Revenue S173,709.7 Mn by 2027 The drug or ‘bioceutics’ is an alternative medicine that is called exercise benefits. In the US, “nutraceuticals” are widely regulated, as they are in the same category as supplements and supplements by the FDA, under the Federal Food, Drug, and Cosmetic Act... Friday, 16 Oct 2020 Read the story
Zebra Medical Vision Secures FDA Clearance in Oncology Zebra Medical Vision, the deep-learning medical imaging analytics company, announced today its sixth FDA 510(k) clearance for its mammography solution, HealthMammo, which has already received a CE mark. Zebra Medical’s algorithm empowers breast radiologists by pri.. Monday, 27 Jul 2020 Read the story
SFA Therapeutics Announces FDA Approval To Begin IND Trial SFA Therapeutics, Inc. is pleased to announce that the US FDA has provided approval to conduct a clinical trial (officially referred to as an IND) for the treatment of "the appearance of the structure of skin with plaques due to psoriasis." SFA plans to expand t.. Monday, 29 Jun 2020 Read the story
Nordic Nanovector's Betalutin® Receives Fast-track Designation from US FDA for Marginal Zone Lymphoma Nordic Nanovector is evaluating the opportunity to develop Betalutin® as a single-agent treatment for MZL, a rare type of non-Hodgkin's lymphoma (NHL). Betalutin® has demonstrated a very promising clinical effect in nine MZL patients in the Phase 1/2a LYMRIT 37-01 .. Monday, 29 Jun 2020 Read the story
GeneQuantum Healthcare (GQ) receives IND clearance by the US FDA for ADC drug GeneQuantum Healthcare focuses on the research and development of various innovative bioconjugate drugs via its innovative LDC technology and the international first-class iLDC platform. The company's iLDC platform utilizes an enzyme-catalyzed intelligent continuous.. Thursday, 11 Jun 2020 Read the story
MIVI Neuroscience Announces FDA IDE Clinical Study Approval For the MIVI Q Aspiration Catheter MIVI Neuroscience, a developer, and marketer of precision stroke therapy devices utilized by neurointerventionists around the world, announced today that the FDA has determined the company has provided sufficient data to support initiation of a human clinical study o.. Wednesday, 10 Jun 2020 Read the story
Ascend to Perform Antibody Testing for COVID-19 Ascend, the dialysis testing laboratory, has begun performing antibody testing for COVID-19. Ascend is one of the first to offer COVID-19 total antibody testing on the Siemens high throughput platform, which can be combined with a patient's regularly scheduled test.. Tuesday, 02 Jun 2020 Read the story
Hikma launches Dicyclomine Hydrochloride Oral Solution Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, has launched Dicyclomine Hydrochloride Oral Solution, USP, 10 mg/5 mL, an AA-rated version of Bentyl®1 Oral Syrup, 10 mg/5 mL in the United States through its US affiliate, Hi.. Thursday, 28 May 2020 Read the story
4DMedical's Lung Imaging Technology Receives FDA Clearance as COVID-19 Intensifies Global Focus on Respiratory Health 4DMedical, an Australian medical technology company specializing in medical imaging innovation software, announced today it has received clearance from the U.S. Food & Drug Administration to market its XV Technology™, a patented four-dimensional lung imaging pr.. Monday, 25 May 2020 Read the story
Hikma receives FDA approval for its generic Vascepa® Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, has announced that its wholly owned U.S. subsidiary Hikma Pharmaceuticals USA Inc. has received approval from the US Food and Drug Administration (FDA) for its Icosapent Ethyl Cap.. Friday, 22 May 2020 Read the story
CardioFocus Announces US FDA Approval of HeartLight® X3 System for the Treatment of Atrial Fibrillation Approval of the HeartLight X3 System came as a result of a comprehensive submission, including outcomes from the study of 60 HeartLight X3 patients. In this pivotal confirmatory study, the X3 System achieved very rapid pulmonary vein isolation (PVI), in as few as thr.. Wednesday, 13 May 2020 Read the story
Diverse Biotech announces orphan-drug designation for treatment of newly diagnosed glioblastoma Diverse Biotech, Inc. www.diversebiotech.com has announced the U.S. Food & Drug Administration (FDA) has grante.. Tuesday, 05 May 2020 Read the story
Green Valley Obtains IND Approval from U.S. FDA for Sodium Oligomannate's International, Phase III Clinical Study On April 8, 2020, Shanghai Green Valley Pharmaceuticals, China received the formal decision letter from the US Food and Drug Administration (FDA) on the Investigational New Drug (IND) application for the GV-971 international multi-center Phase III clinical stu.. Monday, 27 Apr 2020 Read the story
Hand Sanitizer Now Available & In Stock for Purchase - Produced by Lubrication Specialties, Inc. .. Friday, 24 Apr 2020 Read the story
ZEUS Scientific Announces New Rapid SARS-CoV-2 Antibody Test ZEUS's lateral flow test uses patient serum, plasma or whole blood and provides results in 15 minutes. Assay performance has been confirmed by testing sample cohorts from healthy donors, confirmed positive COVID-19 patients and cross-reactive samples acquired from he.. Thursday, 23 Apr 2020 Read the story
The Miami Distilling Company Announces Production of Mass Quantities of Hand Sanitizer to Meet Local and National Demand The Miami Distilling Company, best known as the producer of ultra-premium Toast™ vodka, announced tod.. Thursday, 23 Apr 2020 Read the story
Sea Buckthorn Farm Launches Its Complete Omega All Natural Oil Blend Sea Buckthorn Farm is launching a complete premium quality sea buckthorn oil blend – a whole bundle of nut.. Wednesday, 22 Apr 2020 Read the story
Fosun Pharma Receives FDA Emergency Use Authorization (EUA) For Its COVID-19 RT-PCR Detection Kit According to the website of the U.S. Food and Drug Administration ("FDA"), Shanghai Fosun Pharmaceutical (Group) Co., Ltd ("Fosun Pharma"; Stock Code: 600196.SH, 02196.HK) has received emergency use authorization (EUA) from FDA for.. Monday, 20 Apr 2020 Read the story
B. Braun Receives FDA Emergency Use Authorization for Use of Infusion Pumps with Nebulizers to Treat COVID-19 Patients B. Braun Medical Inc. (B. Braun) announced that the US Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) of B. Braun's Perfusor® Space Syringe Infusion Pump, Infusomat® Space Volumetric Infusion Pump, and Outlook® ES Pump systems for use .. Tuesday, 14 Apr 2020 Read the story
GKN Powder Metallurgy Business FORECAST 3D Launches Face Shields, Stopgap Masks, Nasal Swabs, and Other Critical PPE Products to Battle COVID-19 FORECAST 3D, a GKN Powder Metallurgy company, has announced its production of readily-available protective equipment and testing supplies to aid in the fi.. Wednesday, 08 Apr 2020 Read the story
EchoNous, Inc. Announces FDA Approval for Its New KOSMOS Platform EchoNous is proud to announce FDA approval of its KOSMOS Platform, which consists of a distinctive 8oz. ultrasound-based tool combined with deep learning for clinical assessment of the heart, lungs and abdomen. It is the first tool in medicine to apply the mathemat.. Friday, 27 Mar 2020 Read the story
RELIEF THERAPEUTICS and NeuroRx, Inc. File FDA IND for Aviptadil to Treat COVID-19-induced Respiratory Distress RELIEF THERAPEUTICS Holding AG (SIX: RLF) "Relief", together with NeuroRx, a Delaware Corporation, have filed an Investigational New Drug (IND) Application with the US FDA for a phase 2 trial of RLF-100 (Aviptadil) in the treatment of Acute and Moder.. Thursday, 26 Mar 2020 Read the story
Bought ventilators in China and shipped them to the United States: Elon Musk Tesla bought hospital ventilators in China and shipped them to the United States, CEO Elon Musk said on Tuesday.Tesla’s purchase comes as governments across the globe appeal to automakers and aerospace companies help procure or make ventilators and other med.. Tuesday, 24 Mar 2020 Read the story
FDA suspending routine food facility inspections The Food and Drug Administration is suspending “routine” food facility inspections in an effort to ensure the safety of its workforce and not interfere with food manufacturer programs to limit the number of visitors to their facilities in the wake of the coronavi.. Friday, 20 Mar 2020 Read the story
Medical Assets Acquisition Announced by TheraLight, LLC TheraLight, LLC, an FDA-registered manufacturer and distributor of cutting-edge light therapy products, recently announces it has acquired the assets from Theralight, Inc... Thursday, 12 Mar 2020 Read the story
Quick Tips Healthcare Industry Must Follow for Medical Device & Data Security One of the key reason that probably interests cybercriminals to healthcare industry is patients’ personal data including name, age, date of birth, number, etc. The hackers use these data for stealing the identity of any patient, which is also referred to as identit.. Friday, 28 Feb 2020 Read the story
Innovation Disrupting the Pricing of Drugs in Healthcare Industry The increasing cost of medicine for consumers of the U.S. came back in focus in 2018, as soon as President Trump’s government revealed an extensive policy proposal challenging drug prices, facilitating to reignite the deliberation over the amount patients are payin.. Thursday, 23 Jan 2020 Read the story
Global Recall of the Common Heartburning Drugs Over the Risk of Cancer Ranitidine is an OTC (over-the-counter) & prescription drug with H2 (histamine-2) blocker that is mainly used for decreasing the amount stomach acid. OTC ranitidine has been approved of preventing as well as relieving heartburn accompanying acid ingestion followed by.. Tuesday, 21 Jan 2020 Read the story
Luye Pharma Submits New Drug Application in the U.S. for Its Antidepressant Drug LY03005 Luye Pharma Group has announced submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for LY03005, a new chemical drug for the treatment of major depressive disorder. It is also the second U.S. FDA NDA submission in the central ner.. Friday, 27 Dec 2019 Read the story
FDA Grants Avatrombopag Orphan Drug Designation for the Treatment of Chemotherapy-induced Thrombocytopenia Dova Pharmaceuticals, Inc., a wholly owned subsidiary of Swedish Orphan Biovitrum AB (publ) (Sobi™) has been granted Orphan Drug Designation[1] (ODD) by the US Food and Drug Administration (FDA) for avatrombopag for the potential treament of Chemotherapy-Induced T.. Monday, 23 Dec 2019 Read the story
FDA Approves Diffusion-Weighted Images for Elekta Unity, Expanding Options for Assessment During Therapy Elekta (EKTA-B.ST) today announced that it has received 510(k) premarket notification from the U.S. Food and Drug Administration for the use of diffusion-weighted MR images (DWI) obtained with Elekta Unity to be interpreted by a trained physician. This expands the cl.. Monday, 16 Dec 2019 Read the story
FDA Warns 15 Companies for Illegally Marketing Cannabidiol Containing Products CBD is being advertised in various types of product, such as capsules, oil drops, syrups, food products like chocolate bars & teas as well as topical lotions & creams. A few have publicized it having several homeopathic properties like anxiety, relieving pain and eve.. Tuesday, 10 Dec 2019 Read the story
3D Systems Expands its Industry-Leading Portfolio of Dental Materials with Newly FDA-Cleared NextDent® Denture 3D+ 3D Systems (NYSE:DDD) announced that its new biocompatible denture material, NextDent® Denture 3D+, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The combination of this new dental 3D printing material, NextDent 5100 dental 3D p.. Thursday, 07 Nov 2019 Read the story
Johnson & Johnson Consumer Inc. is Acting Out of an Abundance of Caution Out of an abundance of caution, Johnson & Johnson Consumer Inc. (JJCI) announced that it is initiating a voluntary recall in the Unit.. Friday, 18 Oct 2019 Read the story
First AI Product Cleared for MRI Image Enhancement by FDA Subtle Medical, a healthcare technology company focused on improving the quality, efficiency, and accessibility of medical imaging, announced today 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market SubtleMRTM. SubtleMR is an image processing.. Wednesday, 16 Oct 2019 Read the story
Primary Practicability Trial announced by Medtronic Medtronic plc recently publicizes the news for their acceptance received form the U.S. Food and Drug Administration (FDA) for initiating a primary feasibility study (EFS) for their Intrepid™ transcatheter mitral valve replacement (TMVR) system making use of a marg.. Monday, 07 Oct 2019 Read the story
Boston Scientific Announced FDA Approval of ImageReady MRI For Vercise Gevia Deep Brain Stimulation System Boston Scientific Corporation is a manufacturer, and also engaged in the commercialization of medical devices which are used in wide range of medical specialties. The company offers products for the major seven core businesses such as interventional cardiology, cardi.. Tuesday, 01 Oct 2019 Read the story
Approval From FDA Will Intensify the Global Market of Helicobacter Pylori Non-Invasive Testing According to a new market research study titled ‘Helicobacter Pylori Non-Invasive Testing Market to 2027 – Global Analysis and Forecasts by Test Type, Test Method, End User and Geography. The global Helicobacter pyl.. Wednesday, 11 Sep 2019 Read the story
FDA Expands Use for Ortho's VITROS HIV Combo Test: Menu Milestone for VITROS XT 7600 Integrated System Ortho Clinical Diagnostics, a global leader in vitro diagnostics, announced that it’s VITROS Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (VITROS HIV Combo test) was granted pre-market approval by the U.S. Food and Drug.. Friday, 06 Sep 2019 Read the story