the expected nature and timing of the Company's planned FDA submission and related plans for clinical study amendment, whether the Company's cash position will be sufficient to fund operations needed ...

BridgeBio Pharma’s acoramidis shows improved survival data, boosting approval chances. Read why BBIO stock could see gains if ...

PTC Therapeutics' gene therapy is already approved in the European Union, Great Britain, and Israel. The drugmaker will also ...

A primary benefit of the FDA Fast Track designation is how it accelerates the drug approval process. Early and continuous ...

The recent FDA approval of Kebilidi, a groundbreaking gene therapy for AADC deficiency, is a significant milestone for the company. It is the first gene therapy directly administered to the brain and ...

The pharmacokinetics study showed that fingerprint sweat provides a reliable and comparable sample matrix for drug detection ...

First-ever FDA approval for gene therapy directly administered to the brain - - Priority review voucher granted - - Broad label including children and adults - - PTC pioneers new approach for CNS drug ...

A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting the drug.

Organon is a strong investment opportunity with a high yield, diversified portfolio, steady performance, and transformative ...

Envoy Medical®, Inc. ("Envoy Medical") (Nasdaq: COCH), a revolutionary hearing health company focused on fully implanted hearing devices, today ...

The guidelines took years to finalize, but while regulators were drafting them, a new trend emerged: online pharmaceutical ...

ALL patients who received Aucatzyl immunotherapy, made from their own T cells, experienced complete remission within three ...