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Vanda Pharmaceuticals | Announces U.S. FDA Accepts New Drug Application for Tradipitant for the Treatment of Gastroparesis
NASDAQ: VNDA 1. Introduction to Vanda Pharmaceuticals’ new drug application for Tradipitant Vanda Pharmaceuticals, a leading biopharmaceutical company, has recently announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for Tradipitant, a potential breakthrough treatment for gastroparesis. This acceptance marks a significant milestone in Vanda Pharmaceuticals’ efforts…
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Neurocrine Biosciences | Hosting Analyst Day on December 5, 2023
NASDAQ: NBIX Neurocrine Biosciences to Host Analyst Day on December 5, 2023 Have you heard the news? Neurocrine Biosciences, a leading biopharmaceutical company, is set to host an Analyst Day on December 5, 2023. This highly anticipated event will bring together analysts, investors, and industry experts to explore Neurocrine Biosciences’ latest developments and future prospects.…
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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…