Among reasons for the rejection, the agency cited a lack of US patient representation in the STARGLO trial assessing ...

ISKP is weaker than the BLA in Balochistan. That could restrain it from attacking the latter in the immediate future.

The Baloch Liberation Army (BLA) asserted that its members killed at least seven Pakistani soldiers during a military ...

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

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

Investing.com -- Atara Biotherapeutics Inc (NASDAQ: ATRA) stock surged 7% after the U.S. Food and Drug Administration (FDA) accepted the filing of its Biologics License Application (BLA) for ...

Replimune Group, Inc – a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies – ...

FDA issued Complete Response Letter Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial in Q3 2025 to continue pursuing the indication for the treatment of ...

The Baloch Liberation Army has claimed responsibility for a bomb blast in Quetta that killed Major Anwar Kakar, a senior ...

The FDA's request stems from observations made during recent inspections of Ultragenyx's manufacturing facilities.

The incidents that were carried out over July 15-16 have reportedly left 29 soldiers dead, including a senior officer.

Tabelecleucel, an allogeneic, EBV-specific T-cell immunotherapy, works by targeting and eliminating EBV-infected cells.