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Big News for APDS: FDA Grants Priority Review for Leniolisib in Younger Children
NASDAQ: PHAR Pharming Group has just shared exciting developments regarding their treatment for Activated PI3K-delta Syndrome (APDS). The U.S. Food and Drug Administration (FDA) has formally accepted the supplemental New Drug Application (sNDA) for leniolisib and, significantly, granted it Priority Review status. This is a pivotal moment for the APDS community, particularly for families managing…
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Aquestive Therapeutics: A Significant Step Forward in Regulatory Development
NASDAQ: AQST Investors and stakeholders interested in the pharmaceutical landscape have a compelling reason to examine the latest announcement from Aquestive Therapeutics. The news release, accessible at https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-announces-regulatory-development, signals a crucial milestone in the company’s journey toward bringing innovative therapies to market. Understanding the Context of the Announcement Aquestive Therapeutics operates within the specialized field…
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Checkpoint Therapeutics Announces FDA Acceptance of BLA Resubmission of Cosibelimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma
NASDAQ: CKPT Introduction Checkpoint Therapeutics, a leading biopharmaceutical company, recently made a significant announcement regarding the FDA acceptance of the Biologics License Application (BLA) resubmission of Cosibelimab for the treatment of advanced cutaneous squamous cell carcinoma. This development marks a crucial milestone in the ongoing efforts to provide effective treatment options for patients battling this…
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Axsome Therapeutics Announces FDA Acceptance of NDA Resubmission for AXS-07 for the Acute Treatment of Migraine; PDUFA goal date is January 31 2025
NASDAQ: AXSM Axsome Therapeutics, a leading biopharmaceutical company, has recently announced the exciting news that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. With the FDA acceptance of the NDA resubmission, Axsome Therapeutics is one step closer to…
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BD Receives FDA 510(k) Clearance for Potentially Transformative Fingertip Blood Collection Device
NYSE: BDX 1. Introduction: Overview of BD’s FDA 510(k) Clearance for Potentially Transformative Fingertip Collection Device The field of sample collection in healthcare is about to witness a significant transformation with the recent FDA 510(k) clearance obtained by BD for their groundbreaking fingertip collection device. This innovative device offers a convenient and user-friendly alternative to…
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Calliditas Therapeutics | The FDA Decision To Convert The Accelerated Approval of Calliditas Therapeutics’ Tarpeyo To Full Approval, December 20, 2023
NASDAQ: CALT 1. Introduction to Calliditas Therapeutics and Tarpeyo Calliditas Therapeutics is a renowned pharmaceutical company focused on developing innovative therapies to address unmet medical needs. One of their notable products is Tarpeyo, a drug designed to provide significant benefits to patients suffering from a specific medical condition. The accelerated approval granted by the FDA…
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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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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…