Alpha Tau Submits First Pre-Market Approval Module to the FDA for Alpha DaRT® for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma (cSCC)

Initial module submission marks an important milestone in the pre-market approval process - - Flexible modular submission ...
Morningstar

FDA Approval of Leqembi Subcutaneous Formulation Charts Path to Combination Therapies for Alzheimer's Disease

NEW YORK, Aug. 29, 2025 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today announced its approval of a subcutaneous formulation of Leqembi (lecanemab), branded as Leqembi Iqlik, for ...
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New medications coming soon: Here’s what’s been FDA approved in 2025 so far

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
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Revolutionizing Drug Approvals: FDA Integrates AI for Enhanced Efficiency

The integration of Artificial Intelligence (AI) in various sectors has been nothing short of transformative, and now, it’s poised to revolutionize the pharmaceutical industry. The U.S. Food and Drug ...