FDA Archives - Page 15 of 220

2 minute read

Gilead’s Tecartus Dropped From FDA List Of CAR-T Therapy With Updated Label Warning Of “Risks Of Secondary Cancer’

January 24, 11:36 AM

FDA issues classwide black box warning for CAR-T therapies due to T-cell cancer risk. Drops Gilead's cell therapy from the list.

BMY

2 minute read

UroGen Initiates Submission Of A Rolling NDA To The FDA For UGN-102

By Benzinga Newsdesk

January 24, 9:18 AM

UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced the submission of the Chemistry, Manufacturing,

URGN

1 minute read

Opioid Developer Ensysce Biosciences Stock Is Shooting Higher Today – Here’s Why

By Vandana Singh

January 23, 2:13 PM

Ensysce Biosciences breakthrough in opioid innovation! FDA grants PF614-MPAR BTD for enhanced pain relief with overdose protection. Learn more about this cutting-edge drug.

ENSC

2 minute read

The Biden-Harris Administration Announces New Guidance To Enable Expanded Access To All FDA-Approved Contraceptives Without Cost

By Benzinga Newsdesk

January 23, 10:30 AM

Implementation of the New Guidance Could Eliminate Financial Barriers for Contraceptive Products like Twirla® for 49 Million Women These Actions Follow Several Months of Activity by the Biden Administration to

AGRX

2 minute read

Focus On Bristol Myers, Gilead Sciences, Johnson & Johnson, Novartis: FDA To Issue Classwide Black Box Warning on CAR-T Therapies For Blood Cancer Treatment

By Vandana Singh

January 23, 9:19 AM

In a significant development, the FDA is set to impose a classwide black box warning following its investigation into secondary T-cell cancers arising from the use of existing CAR-T therapies.

AZN

2 minute read

AngioDynamics Announces FDA 510(k) Clearance Of Auryon XL Radial Access Catheter To Treat Peripheral Arterial Disease

By Benzinga Newsdesk

January 23, 9:15 AM

225-cm Catheter Length Expands Access Points in Atherectomy Procedures to Help Reduce Access Site Complications and Accelerate Patient RecoveryAngioDynamics, Inc. (NASDAQ:ANGO), a leading and transformative medical

ANGO

1 minute read

FDA
News

FDA Reported Monday It Is Requiring Boxed Warning For CAR-T Cancer Therapies

By Charles Gross

January 23, 6:13 AM

https://www.fda.gov/media/175627/download?attachment https://www.fda.gov/media/175626/download?attachment https://www.fda.gov/media/175625/download?attachment https://www.fda.gov/media/175624/download?attachment https://www.fda.gov/media/175622/download?attachment https://www.fda.gov/media/175623/download?attachment

BMY

2 minute read

60 Degrees Pharmaceuticals Outlines Plans For Rare Tick-Borne Infection Trial Evaluating Its Malaria Drug

By Vandana Singh

January 22, 2:45 PM

60P Pharmaceuticals advances pivotal study of tafenoquine in hospitalized babesiosis patients after FDA meeting.

SXTP

1 minute read

FDA Clears Pharvaris’ Trial For Investigational Drug For Swollen Blood Vessels, Stock Jumps

By Vandana Singh

January 22, 1:28 PM

Pharvaris receives FDA approval to advance deucrictibant for hereditary angioedema prophylaxis, lifting clinical hold. Learn about the latest developments in HAE treatment.

PHVS

2 minute read

Johnson & Johnson Secures Complete FDA Approval For Bladder Cancer Drug Balversa, After Almost Five Years Of Accelerated Approval

By Vandana Singh

January 22, 12:59 PM

FDA-approved Balversa for urothelial carcinoma treatment. The first oral FGFR kinase inhibitor offers clinical benefits, extended overall survival, and a breakthrough for FGFR alterations in metastatic UC.

AMAM