US Food and Drug Administration
European Commission approves HIV prevention injection
August 28, 2025Medical 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 …
FDA approves Wegovy for treatment of MASH in adults with liver fibrosis
August 22, 2025Medical 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 …
FDA decision on Neurizon’s ALS therapy delayed until October
August 18, 2025Medical 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 …
FDA approves first new fibromyalgia therapy in over 15 years
August 18, 2025Medical 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 …
Novartis candidate for Sjögren’s disease presents positive results
August 15, 2025Research 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 …
Faron reports increased remission rate in trial for myelodysplastic syndrome candidate
August 7, 2025Medical 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 …
FDA grants orphan drug designation to relapsed or refractory multiple myeloma candidate
August 6, 2025Medical 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 …
Johnson & Johnson submits FDA application for Caplyta to prevent schizophrenia relapse
July 18, 2025Medical 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 …
FDA approves Moderna’s Spikevax for children at increased risk of COVID-19
July 16, 2025Medical 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 …
Pharvaris to report phase 3 data and submit New Drug Application
July 15, 2025Medical 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 …
Duke Street Bio receives FDA fast track designation for brain metastases treatment
July 8, 2025Medical 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) …
FDA grants accelerated approval for advanced non-small cell lung cancer treatment
July 4, 2025Medical 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 …
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FibroFind appoints Lee Borthwick as CEO
