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US Food and Drug Administration

Showing 12 posts of 12 posts found.

European Commission approves HIV prevention injection

August 28, 2025
Medical Communications, Research and Development European Commission, Gilead Science, HIV, HIV/AIDS, US Food and Drug Administration, World Health Organisation

The European Commission (EC) has granted marketing authorisation for Gilead Science’s Yeytuo (lenacapavir), the first twice-yearly injectable medicine approved in …

News
hsm_mobile_clinical_trial_istock-872676342

FDA approves Wegovy for treatment of MASH in adults with liver fibrosis

August 22, 2025
Medical Communications, Research and Development Hepatology, Novo Nordisk, US Food and Drug Administration, clinical trial, hepatitis, obesity

The US Food and Drug Administration (FDA) has granted accelerated approval for Wegovy (semaglutide) as a treatment for adults with …

News
brain_anatomy_medical_head_skull_digital_3_d_x_ray_xray_psychedelic_3720x2631

FDA decision on Neurizon’s ALS therapy delayed until October

August 18, 2025
Medical Communications Coya Therapeutics, Neurizon, Neurology, US Food and Drug Administration, amyotrophic lateral sclerosis

Neurizon Therapeutics has announced that the US Food and Drug Administration (FDA) will delay its decision on the company’s Clinical …

News

FDA approves first new fibromyalgia therapy in over 15 years

August 18, 2025
Medical Communications, Research and Development Pain, Tonix Pharmaceutical, US Food and Drug Administration, chronic pain, clinical trial, fibromyalgia

The US Food and Drug Administration (FDA) has approved Tonix Pharmaceutical’s Tonmya (cyclobenzaprine hydrochloric acid) for the treatment of fibromyalgia …

News
drug-trials

Novartis candidate for Sjögren’s disease presents positive results

August 15, 2025
Research and Development Immunology, Novartis, Sjögren’s disease, US Food and Drug Administration, clinical trial

Novartis has reported positive results from two phase 3 clinical trials – NEPTUNUS-1 and NEPTUNUS-2 – evaluating ianalumab in adults …

News
drug-trials

Faron reports increased remission rate in trial for myelodysplastic syndrome candidate

August 7, 2025
Medical Communications, Research and Development Faron Pharmaceuticals, Oncology, US Food and Drug Administration, acute myeloid leukemia, myelodysplastic syndrome

Faron Pharmaceuticals has reported a rise in complete remission (CR) rates among patients with frontline high-risk myelodysplastic syndrome (HR-MDS) in …

News
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FDA grants orphan drug designation to relapsed or refractory multiple myeloma candidate

August 6, 2025
Medical Communications, Research and Development Oncology, Sanofi, US Food and Drug Administration, myeloma

The US Food and Drug Administration (FDA) has granted orphan drug designation to SAR446523, Sanofi’s investigational monoclonal antibody developed for …

News
Brain image

Johnson & Johnson submits FDA application for Caplyta to prevent schizophrenia relapse

July 18, 2025
Medical Communications, Research and Development CAPLYTA, Johnson & Johnson, Neurology, US Food and Drug Administration, neuroscience, new drug application, schizophrenia

Johnson & Johnson has submitted a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Caplyta …

News
Vaccine image

FDA approves Moderna’s Spikevax for children at increased risk of COVID-19

July 16, 2025
Medical Communications COVID-19, Spikevax, US Food and Drug Administration, Vaccine, Virology

Moderna has been granted US Food and Drug Administration (FDA) approval for its COVID-19 vaccine, Spikevax, in children aged six …

News
clinical_trial-web

Pharvaris to report phase 3 data and submit New Drug Application

July 15, 2025
Medical Communications, Research and Development Pharvaris, Rare Diseases, US Food and Drug Administration, clinical trial, genetic condition, new drug application

Pharvaris has announced that its data from its phase 3 study of deucrictibant immediate-release capsules (IR) for the treatment of …

News
brain_scan_small

Duke Street Bio receives FDA fast track designation for brain metastases treatment

July 8, 2025
Medical Communications, Research and Development Duke Street Bio, Oncology, US Food and Drug Administration, brain metastases, breast cancer, fast track designation

Duke Street Bio, a biotech company based in London, UK, has announced that the US Food and Drug Administration (FDA) …

News

FDA grants accelerated approval for advanced non-small cell lung cancer treatment

July 4, 2025
Medical Communications, Research and Development Breakthrough Therapy Designation, Oncology, US Food and Drug Administration, Zegfrovy, clinical trial, non-small cell lung cancer, priority review

The US Food and Drug Administration (FDA) has granted accelerated approval to Dizal Therapeutic’s Zegfrovy (sunvozertinib) for the treatment of …

News
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STADA and Bio-Thera’s Gotenfia receives positive CHMP opinion for autoimmune diseases

December 18, 2025

Norgine enters exclusive licensing agreement with Vir Biotechnology

December 18, 2025

Incyclix appoints Kimberly Blackwell to Board of Directors

December 17, 2025

Hansa Biopharma appoints Max Sakajja as Vice President, General Manager Europe and International

December 17, 2025

GSK’s Exdensur receives MHRA approval for asthma and rhinosinusitis

December 16, 2025