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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.…