Urcosimod has received FDA fast track designation for neuropathic corneal pain, enabling expedited regulatory processes and ...

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

INX-315, a CDK2 inhibitor, gained FDA fast track status in CCNE1-positive platinum-resistant/refractory ovarian cancer.

TLX101-CDx is an investigational positron emission tomography agent that targets the membrane transport proteins, LAT1 and LAT2.

Retail investor interest in Q32 Bio Inc picked up on Wednesday after the clinical-stage biotech said the U.S. Food and Drug ...

Drugs receiving FTD may also be eligible for Accelerated Approval and Priority Review if relevant criteria are met. More information on the FDA's Fast Track process is available here. Q32 Bio is a ...

The Fast Track designation provides several key benefits, including more frequent meetings with the FDA to discuss the drug’s development plan, eligibility for Accelerated Approval and Priority Review ...

There is currently no FDA-approved targeted amino acid PET agent for brain cancer imaging available in the US. TLX101-CDx was previously granted Orphan Drug and Fast Track designations by the FDA.

At FDA, full vaccine approval is the gold standard. The agency was on track to sign off on Novavax’s license by its April 1 target date, according to two people with direct knowledge of the ...

Novavax's closely watched COVID-19 vaccine is on track for full approval after additional discussions with the FDA, the company said Wednesday. The news sent company shares soaring more than 21% ...