Alpha Tau Announces Acceptance Into FDA’s Total Product Life Cycle Advisory Program to Accelerate Market Access to Alpha DaRT® for Patients with Recurrent Glioblastoma Multiforme
Alpha Tau Medical Ltd. - Ordinary Shares (DRTS)
Company Research
Source: GlobeNewswire
JERUSALEM, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-emitters cancer therapy Alpha DaRT®, announced today that it has been accepted into the prestigious Total Product Life Cycle (TPLC) Advisory Program (“TAP”) Pilot of the U.S. Food and Drug Administration (“FDA”), to accelerate market access to the Alpha DaRT for patients with recurrent glioblastoma multiforme (“GBM”). This acceptance follows the Company’s previous receipt of Breakthrough Device Designation from the FDA for this indication, one of two such designations received for the Alpha DaRT, and a pre-requisite for application to the TAP program. TAP’s primary goal is to expedite and enable patient access to innovative and highly promising medical devices which are not currently on the market by providing early, frequent, and strategic communications with the FDA, and by facilitating engagement with other key parties
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DRTS
Sec Filings
- 11/19/24 - Form 6-K
- 11/13/24 - Form 6-K
- 11/12/24 - Form 6-K
- DRTS's page on the SEC website