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 ...

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 ...

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 ...

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 ...

VERV’s VERVE-102 showed an impressive 69% LDL-C reduction in its early Phase 1b data. Click here to find out why I rate VERV ...

Arcturus Therapeutics Holdings has won U.S. Food and Drug Administration fast-track designation for its ARCT-2304 pandemic flu vaccine candidate.

The FDA has granted Fast Track designation to Biogen’s BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau for the treatment of Alzheimer disease (AD). In a press release ...

Novavax says its closely watched COVID-19 vaccine is on track for full U.S. approval after additional discussions with the ...