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..

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..

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..

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..

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 This shift followed industry concerns about outdated definitions and consumer confusion.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..

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..

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..

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..

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...

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..

 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..

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 ..

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..

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..

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..

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..

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..

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..

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..

Diverse Biotech, Inc. www.diversebiotech.com has announced the U.S. Food & Drug Administration (FDA) has grante..

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..

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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..

 The Miami Distilling Company, best known as the producer of ultra-premium Toast™ vodka, announced tod..

Sea Buckthorn Farm is launching a complete premium quality sea buckthorn oil blend – a whole bundle of nut..

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..

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 ..

FORECAST 3D, a GKN Powder Metallurgy company, has announced its production of readily-available protective equipment and testing supplies to aid in the fi..

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..

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..

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..

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..

TheraLight, LLC, an FDA-registered manufacturer and distributor of cutting-edge light therapy products, recently announces it has acquired the assets from Theralight, Inc...

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..

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..

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..

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..

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..

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..

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..

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..

Out of an abundance of caution, Johnson & Johnson Consumer Inc. (JJCI) announced that it is initiating a voluntary recall in the Unit..

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..

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..

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..

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..

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..

According to the recent studies performed in the field of narcolepsy therapeutics, combination therapy has emerged as a more effective solution for sleepiness in comparison to the efficiency exhibited by a single drug. In February 2019, Har..

Medtronic plc announced that is has received FDA approval for its pipeline product, Flex em..