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ADDF Statement on FDA Decision Not to Grant Accelerated Approval to Donanemab for Treatment of Alzheimer’s Disease

Drugmaker Eli Lilly & Co announced that the FDA has issued a complete response letter, meaning it has not granted accelerated approval for amyloid-clearing...

FDA Grants Appeal for Ardelyx’s XPHOZAH

Ardelyx, Inc., a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, announced...

Akebia Therapeutics Received Interim Response to Appeal for Vadadustat

Akebia Therapeutics, Inc., a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, announced that the company received...

Overhearing.com Launches Online OTC Hearing Aid Shopping Experience

Overhearing.com announced immediate availability of over-the-counter hearing aids, enabling Americans to alleviate mild to moderate hearing loss without the need for a prescription. "These new...

U.S. FDA Designates Alexis Bio’s realSKIN as Regenerative Medicine Advanced Therapy

Alexis Bio, a private regenerative medicine company, announced that realSKIN™ is the first live cell xenotransplant product to be designated as a Regenerative Medicine...
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