Breakthrough Devices Program | FDA
WEBThe Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening...
Updated Final Guidance on Breakthrough Devices Program
WEBSep 14, 2023 · As of June 30, 2023, CDRH has granted Breakthrough Device designation to 831 devices and granted marketing authorization to 77 devices with Breakthrough Device designation.
Breakthrough Therapy Approvals | FDA
WEBJul 23, 2024 · The CDER Breakthrough Therapy (BT) Approvals reports contain a list of approvals for breakthrough therapy designated drugs. New reports will be published quarterly for the current calendar...
Pfizer’s Elranatamab Granted FDA Breakthrough Therapy Designation …
WEBNov 3, 2022 · NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) today announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of people with relapsed or refractory multiple myeloma (RRMM).
GSK receives US FDA Breakthrough Therapy Designation for its …
WEBAug 20, 2024 · Regulatory designation based on promising early clinical evidence observed with GSK5764227 in this tumour type. Breakthrough Therapy Designation aims to expedite development and review of drugs with potential to show improvement over available therapies for serious conditions.
Breakthrough Therapy Designation for Novel Targeted Releasing …
WEBDec 4, 2023 · Breakthrough Therapy Designation for Novel Targeted Releasing System Based on Results from Ongoing Phase 2b SunRISe-1 Study. RARITAN, N.J., Dec. 4, 2023 – Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted TAR-200 Breakthrough Therapy Designation (BTD) for the potential future treatment of patients ...
Musk's Neuralink gets FDA's breakthrough device tag for …
WEB4 days ago · Elon Musk's brain-chip startup Neuralink said on Tuesday its experimental implant aimed at restoring vision received the U.S. Food and Drug Administration's "breakthrough device" designation.
Neuralink says the FDA designated its Blindsight implant as a
WEBThe FDA also prioritizes breakthrough devices for review. Ultimately, a breakthrough device designation can accelerate development of a technology. Last year, the FDA gave the designation to 145 ...
FDA Grants Breakthrough Therapy Designation to Sublingual …
WEBSep 10, 2024 · Breakthrough Therapy designation is intended to expedite the development and review of drugs that treat serious conditions with positive preliminary clinical evidence. Products that receive Breakthrough Therapy designation are granted all the features of Fast Track designation as well as guidance in an efficient drug development program.
FDA Grants Breakthrough Therapy Designation to Sunvozertinib …
WEBApr 7, 2024 · The FDA's Breakthrough Therapy Designation is intended to expedite the development and regulatory review of drugs for serious or life-threatening conditions. To qualify, new...