The American Journal of Managed Care

FDA Approves Vepdegestrant for ESR1-Mutated, ER-Positive, HER2-Negative Advanced Breast Cancer

Vepdegestrant becomes the first FDA-approved heterobifunctional protein degrader (PROTAC) in breast cancer, targeting ER ...
BioSpace

FDA clears Pfizer, Arvinas’ novel breast cancer therapy despite mixed data

Veppanu, the first PROTAC therapy approved by the FDA, improved progression free survival by 43% versus AstraZeneca’s ...
Government Executive

FDA to pilot real-time clinical drug trials through cloud and AI

The first-of-its-kind pilot could lead to speedier regulatory approval of medical drugs and devices and potentially reduce ...
InvestorsHub on MSN

FDA resubmission path for Tab-cel keeps Atara’s (ATRA) regulatory timeline alive

Atara Biotherapeutics said the FDA outlined a potential pathway for resubmitting the tabelecleucel application after a recent ...
Medscape

In the Race to the First Psychedelic Approval, Who’s Leading?

A new FDA regulatory pathway could accelerate approval of psychedelic therapies for resistant depression and PTSD, and ...

Scholar Rock anticipates apitegromab approval by September 30 as FDA accepts SMA BLA with two fill-finish sites

"I am very pleased to announce that the FDA has accepted for review our biologics license application for apitegromab for the treatment of children and adults living with SMA." (CEO & Chairman David ...