News

BioInvent International: BioInvent Receives FDA Fast Track Designation for BI-1808 for the Treatment of Cutaneous T-cell Lymphoma
LUND, SE / ACCESS Newswire / April 29, 2025 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a biotech company focused on the discovery and development of novel and first-in-class i ...
Infectious Disease Advisor22h
Potentially Curative Gene Editing Tx for Chronic HBV Gets Fast Track Status
PBGENE-HBV is designed to potentially cure chronic hepatitis B by eliminating the root cause of the virus. The Food and Drug Administration (FDA) has granted Fast Track designation to PBGENE-HBV, an ...
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Arcturus Gets FDA's Fast Track Tag for Influenza Vaccine Candidate
Arcturus Therapeutics Holdings Inc. ARCT announced that the FDA has granted a Fast Track designation to its self-amplifying mRNA (sa-mRNA) vaccine candidate, ARCT-2304, for active immunization to ...
CURE3d
Evorpacept With Keytruda Did Not Elicit Responses in Head and Neck Cancer
In advanced head and neck squamous cell carcinoma, evorpacept and Keytruda didn’t meet the primary endpoints of the ASPEN-03 ...
pharmaphorum2d
FDA fast-tracks NeuroVive's traumatic brain injury drug
With the Fast Track designation from the FDA, NeuroVive is eligible for more frequent meetings and communication with the FDA during the development process, and feedback on each section of its ...
pharmaphorum4d
FDA fast-tracks Merck's cancer blockbuster-in-waiting
Evofosfamide already has fast-track status in the US as a treatment for soft tissue sarcoma (STS) and – if approved by the FDA – could quickly generate sales in excess of $1 billion in each ...
Novavax says its COVID-19 shot is on track for full FDA approval after delay
Novavax says its closely watched COVID-19 vaccine is on track for full U.S. approval after additional discussions with the ...