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Soligenix | Receives FDA IND Clearance for Phase 2 Clinical Trial of Dusquetide in the Treatment of Aphthous Ulcers in Behçet’s Disease
NASDAQ: SNGX Introduction to Soligenix’s Phase 2 Clinical Trial Soligenix, a biopharmaceutical company focused on developing innovative therapies, has recently received FDA Investigational New Drug (IND) clearance for the Phase 2 clinical trial of Dusquetide in the treatment of aphthous ulcers in Behçets Disease. This clearance marks a significant milestone in the development of potential…
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Carisma Therapeutics | Announces FDA Clearance of IND Application for CT-0525, a Novel HER2-Targeting CAR-Monocyte
NASDAQ: CARM Carisma Therapeutics, a leading biotechnology company committed to developing innovative cancer treatments, recently made a groundbreaking announcement. The company has successfully obtained clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application. This is a significant milestone for Carisma Therapeutics, as it paves the way for the…
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BrainStorm Cell Therapeutics | Announces FDA Advisory Committee Meeting to Review NurOwn® PDUFA Target Action Date Scheduled for December 8, 2023
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced that the US FDA has granted the company a meeting to discuss the regulatory path forward for NurOwn® in ALS. The meeting, scheduled for December 6, 2023, will focus on plans for a Special Protocol Assessment (SPA) for a confirmatory Phase 3 trial in ALS. BrainStorm aims to…
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Arcutis Biotherapeutics | FDA Acceptance of New Drug Application for Roflumilast Foam 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older
NASDAQ: ARQT WESTLAKE VILLAGE, Calif., April 18, 2023 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company’s new drug application (NDA) for roflumilast foam 0.3% for the treatment of seborrheic…
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Rocket Pharmaceuticals | Unlocking the Potential: RP-L201 and its FDA Designations – A Breakthrough in Pediatric Medicine
NASDAQ: RCKT Rocket Pharmaceuticals has achieved significant milestones with their groundbreaking therapy, RP-L201. The FDA has granted several prestigious designations to RP-L201, including Regenerative Medicine Advanced Therapy (RMAT), Rare Pediatric, Fast Track, and Orphan Drug designations. These designations highlight the immense potential of RP-L201 in treating pediatric patients and emphasize the urgent need for innovative…
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Aquestive Therapeutics | FDA Acceptance of Libervant™ for Treatment of Seizure Clusters in Young Patients
NASDAQ: AQST The FDA has recently accepted the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film, aiming to tackle the treatment of seizure clusters in children between the ages of two and five. This development provides hope for young patients and their families who have pbeen struggling with the challenges of managing seizure clusters.…