FDA

News and Updates by the Food and Drugs Administration (FDA)

Akoya Biosciences and NeraCare Sign Agreement to Advance and Market Immunoprint Test for Early-Stage Melanoma

Akoya Biosciences, Inc., known for its advancements in spatial biology, and NeraCare, a renowned innovator in laboratory test development for melanoma prognosis, have entered into an exclusive international license agreement. This partnership aims to evolve and commercialize NeraCare’s Immunoprint test […]

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Spruce Biosciences Shares Key Findings from CAHmelia-204 and CAHptain-205 Trials in Congenital Adrenal Hyperplasia

Spruce Biosciences, Inc., a company progressing towards late-stage drug development, is committed to introducing groundbreaking treatments for neurological and endocrine disorders faced with significant unmet medical requirements. Recently, they unveiled the primary outcomes from their trial, CAHmelia-204, regarding tildacerfont’s role

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NeurAxis Achieves US FDA Clearance for RED Device Targeting Chronic Constipation Evaluation

NeurAxis, Inc., a medical company specializing in neuromodulation treatments for persistent and challenging conditions affecting both children and adults, has revealed that the US Food and Drug Administration (FDA) has provided 510(k) clearance for their RED (Rectal Expulsion Device). This

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NIH Research Reveals Tecovirimat’s Safety in Mpox Cases without Impacting Lesion Healing or Pain Relief

An analysis of interim data from the international Study of Tecovirimat for Mpox (STOMP) revealed that the antiviral drug, tecovirimat, did not expedite the healing of lesions or mitigate pain in adults experiencing mild to moderate clade II mpox who

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MHRA in the UK Awards Leo Pharma Authorization for Delgocitinib to Address Moderate to Severe Adult Chronic Hand Eczema

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has given the green light for the use of delgocitinib (Anzupgo) to treat adults suffering from moderate to severe chronic hand eczema when topical corticosteroids prove ineffective or unsuitable.

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Cellectar Biosciences Reveals Progress on Phospholipid Ether Drug Conjugate Platform Targeting Oncology

Cellectar Biosciences, Inc., a clinical-stage biopharmaceutical company specializing in developing and marketing innovative cancer therapeutics, has unveiled an update on its clinical development efforts surrounding its exclusive phospholipid ether drug conjugate platform. This technology facilitates the delivery of diverse therapeutic

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Daiichi Sankyo Begins Vanflyta Dosing in QuANTUM-Wild Phase 3 Trial for Newly Diagnosed FLT3-ITD Negative AML Patients

The initial patient has commenced treatment in the QuANTUM-Wild phase 3 study, investigating the use of Daiichi Sankyo’s Vanflyta (quizartinib) alongside standard intensive induction and consolidation chemotherapy. This is followed by single-agent maintenance in adults diagnosed with FLT3-ITD negative acute

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Innovative Carbon Ion Therapy Approach for Tackling Large Tumours: Research Insights

A groundbreaking research project has unveiled a new strategy that improves the treatment of large sacral chordomas through carbon ion therapy. This study emphasizes optimizing dose-averaged linear energy transfer (LETd), a pivotal factor in radiotherapy that enhances treatment effectiveness for

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FDA Accelerates Approval Process for Sanofi’s Vaccines Targeting Flu and Covid-19 in Older Adults

The U.S. Food and Drug Administration (FDA) has expedited the approval process for two of Sanofi’s combined vaccine candidates that aim to protect individuals aged 50 and above from influenza and Covid-19. These candidates integrate existing vaccines that have demonstrated

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