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Pharmaceutical Industry › Food and Drug Administration (FDA) › Breakthrough Therapy Designation

Arnall Golden Gregory LLP

Break On Through to the Other Side, Part 2: FDA Issues Draft Guidance About Breakthrough Therapy Designation Rescission

Arnall Golden Gregory LLP on

In September 2014, AGG prepared a Bulletin on the Food and Drug Administration’s Breakthrough Therapy Designation (BTD) program, referencing The Doors’ “Break On Through to the Other Side.” Time for Part 2. FDA issued a draft...more

Knobbe Martens

Alpha Tau Receives FDA Breakthrough Device Designation for Alpha DaRT Treatment of GBM

Knobbe Martens on

Alpha Tau Medical Ltd. (“Alpha Tau”) is a medical technology start-up focused on the research, development, and commercialization of its Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) treatment for solid cancerous...more

Seyfarth Shaw LLP

FDA Announces the Creation of CTAP—Coronavirus Treatment Acceleration Program—to Assist Drug Developers and Evaluators

Seyfarth Shaw LLP on

The US Food and Drug Administration (FDA) is prioritizing the development and review of new therapies to treat COVID-19 through a recently created special emergency program titled Coronavirus Treatment Acceleration Program...more

Knobbe Martens

FDA Grants Breakthrough Status to Dthera Sciences' Alzheimer's Therapeutic

Knobbe Martens on

On August 23, 2018, Dthera Sciences announced that the Food and Drug Administration granted Breakthrough Therapy designation to its Alzheimer’s disease therapeutic device. According to the FDA, Breakthrough Therapy...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Draft Guidance on Breakthrough Devices Program

Wilson Sonsini Goodrich & Rosati on

The U.S. Food and Drug Administration (FDA) recently released draft guidance on the new "Breakthrough Devices Program," which was established by the 21st Century Cures Act. This new program supersedes and combines features of...more

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