CURE

FDA Grants Breakthrough Therapy Designations to AbbVie's Temab-A in Colorectal and Lung Cancers

The FDA has granted two Breakthrough Therapy Designations to telisotuzumab adizutecan (Temab-A, also known as ABBV-400), an ...

FDA Grants SeaStar Medical Breakthrough Device Designation for its SCD Therapy for the Treatment of Hyperinflammation in Adult Patients with Sepsis or a Septic Condit…

Potentially accelerates development, assessment, and review for approval by FDA Sepsis impacts about 1.7 million U.S. adults ...
Zacks Investment Research on MSN

AbbVie's Temab-A Gets Two FDA Breakthrough Therapy Tags in Cancer

AbbVie ABBV announced that the FDA has granted two Breakthrough Therapy designations (BTDs) to its investigational ...
InvestorsHub on MSN

HeartBeam receives FDA breakthrough device designation for heart attack assessment

The designation gives HeartBeam prioritized FDA interaction as it prepares a pivotal study of its 3D ECG technology for ...

AbbVie's Telisotuzumab Adizutecan (Temab-A) Receives Two Breakthrough Therapy Designations From the U.S. FDA for CRC and NSCLC

AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has granted two Breakthrough Therapy Designations (BTDs) for telisotuzumab adizutecan (Temab-A; ABBV-400) in ...
MarketScreener

AbbVie Receives Two Breakthrough Therapy Designations From The U.S. FDA For Telisotuzumab Adizutecan In Colorectal Cancer And Non-Small Cell Lung Cancer

AbbVie announced that the U.S. Food and Drug Administration (FDA) has granted two Breakthrough Therapy Designations (BTDs) for telisotuzumab adizutecan (Temab-A; ABBV-400) in colorectal cancer (CRC) ...
RTTNews

AbbVie's Temab-A Earns FDA Breakthrough Therapy Designations In CRC, NSCLC;Stock Up

AbbVie ( ABBV ), a biopharmaceutical company, announced that the U.S. FDA has granted two Breakthrough Therapy Designations for telisotuzumab adizutecan (Temab-A; ABBV-400) in colorectal cancer (CRC) ...
RTTNews

SeaStar Gets FDA Breakthrough Device Designation For SCD In Adult Sepsis; Stock Up

SeaStar Medical Holding Corp. ( ICU ), a commercial-stage healthcare company, said the U.S. FDA has granted Breakthrough Device Designation to its Selective Cytopheretic Device (SCD) therapy for ...
MassDevice

Medtronic snags breakthrough designation for below-the-knee drug-coated balloon

The In.Pact BTK is slated for a pivotal trial of about 400 people with peripheral artery disease in the lower legs facing ...
Labroots

FDA Grants "Breakthrough Device Designation" for Early Cancer Detection Test

The United States Food and Drug Administration (FDA) issued guidance on its “Breakthrough Devices Program” in 2023. The program grants a designation to certain medical devices that provide more ...
StreetInsider.com

HeartBeam wins FDA breakthrough tag for at-home heart attack tool

HeartBeam, Inc. (NASDAQ: BEAT) announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to the HeartBeam System for assessing potential heart ...
Healio

FDA grants breakthrough therapy designation to enpatoran for cutaneous lupus

Please provide your email address to receive an email when new articles are posted on . In the WILLOW study, enpatoran significantly improved disease activity in patients with active cutaneous ...