Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

The 328.8 mg dose demonstrated efficacy and rapid onset compared with placebo ... Only one participant reported suicidality ...

The European Medicines Agency has recommended the approval of lenacapavir, a new bi-annual injectable drug aimed at ...

At a recent FDA panel on SSRIs in pregnancy, the chair suggested rising antidepressant use may be contributing to — not ...

Overview of Therapeutic Drug Monitoring MarketThe Global Therapeutic Drug Monitoring Market is valued at USD 2.5 Billion in ...

Overview of Companion Diagnostics MarketThe Companion Diagnostics Market is evolving rapidly, driven by the growing demand ...

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in ...

The FDA has accepted the resubmitted BLA for tabelecleucel (tab-cel), intended for the treatment of Epstein-Barr virus ...

AstraZeneca's gefurulimab showed clinical benefits and favorable safety in Phase 3 trial for adults with anti-AChR ...

A doctor has urged patients to proceed with caution when using cannabis during cancer immunotherapy and called for more ...

The CRL was given because the FDA did not consider the phase 1/2 IGNYTE trial to be an adequate and well-controlled clinical ...

FDA extends Blenrep combo review to October to assess more data from Phase 3 trials in relapsed or refractory multiple myeloma.