Basel, Switzerland – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of lupus nephritis. The filing acceptance is based on positive results from the phase III REGENCY study,...
Latest News
OSAKA, Japan & CAMBRIDGE, Mass. — Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) and granted Priority Review for oveporexton (TAK-861) for the treatment of narcolepsy type 1 (NT1). Oveporexton is an investigational oral orexin receptor 2 (OX2R)-selective agonist designed...
MELBOURNE, Australia and INDIANAPOLIS, Indiana — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Company’s resubmitted New Drug Application (NDA) for TLX101-Px1, (Pixclara®2, Floretyrosine F 18 or 18F-FET), an investigational PET3 agent for the imaging of glioma (brain...
On March 22, an FDA Advisory Committee (AdCom) unanimously voted in favor of accelerated approval for Biogen’s tofersen for a rare form of amyotrophic lateral sclerosis (ALS). Panelists voted 9-0 that tofersen’s demonstrated reduction in plasma neurofilament—a biomarker of neurodegeneration—was “reasonably likely” to predict clinical benefit in ALS. The AdCom...
Washington DC – The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee agreed that Vertex Pharmaceuticals had sufficiently demonstrated the safety of its investigational sickle cell disease gene-edited therapy exagamglogene autotemcel (exa-cel). Still, the panel of external experts did indicate that Vertex and its partner CRISPR Therapeutics could follow treated...
Most parents wouldn’t be thrilled with the idea of their kids getting hooked up to an IV bag filled with trillions of viruses. But for Melanie Hennick, whose son, Connor, has Duchenne muscular dystrophy, it was an opportunity she hoped would change his life. “We knew this wasn’t a cure,”...
ODAC recommendation based on the positive progression-free survival and clinical benefit in the Phase 3 AQUILA study If approved, DARZALEX FASPRO® would be the first treatment to potentially delay or prevent progression to multiple myeloma RARITAN, N.J. — Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) Oncologic...
PLYMOUTH MEETING, Pa. — INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the FDA has notified INOVIO that it agrees with its rolling submission timeline for the BLA for...
BOSTON, Mass. and SURESNES, France — Servier, a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves, today announced the FDA filing acceptance and priority review for a New Drug Application (NDA) for vorasidenib, as well as the EMA granting accelerated assessment for the...
BONITA SPRINGS, Fla. — Curadel Pharma, a pioneer in zwitterionicity and innovator in advanced radiotherapies and imaging drugs, announced today that CPI-008 (cRGD-ZW800-1), a novel integrin-targeted, zwitterionic imaging drug for margin detection of pancreatic cancer during surgery, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug...