Patients always have hope if their cancers are detected early. Thanks to advanced research and therapies, the earlier the cancer is diagnosed and treated, the better the chance of it being cured.…
The US Food and Drug Administration (FDA) has accepted for filing Krystal Biotech’s KRYS Biologics License Application (BLA) for its lead candidate B-VEC in the treatment of patients with dystrophic…
The U.S. Food and Drug Administration (FDA) has approved Bluebird bio’s BLUE lead asset ZYNTEGLO (betibeglogene autotemcel) to treat the underlying genetic cause of beta‑thalassemia in adult and pediatric patients who…
Ventyx Biosciences VTYX announced positive data from the Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trial of VTX958, a novel and selective allosteric TYK2 inhibitor. The…
Aptinyx Inc. APTX announced results from a Phase 2b clinical study evaluating the effects of NYX-2925 in patients with fibromyalgia. The Phase 2b clinical study was designed to evaluate the…
The European Commission has granted orphan medicinal product designation in the EU to Relief Therapeutics and Acer Therapeutics’ ACER lead asset ACER-001 (sodium phenylbutyrate) for the potential treatment of patients with…
The European Commission (EC) has granted marketing authorization for Argenx’s ARGX lead asset VYVGART (efgartigimod alfa-fcab) as an add-on to standard therapy for the treatment of adult patients with generalized…
Rani Therapeutics RANI announced positive topline results from the single-ascending dose (SAD) portion of its Phase 1 clinical study of its lead asset RT-102 for the potential treatment of osteoporosis.…
Lexaria Bioscience Corp. LEXX announced that it has received a positive full written response from the Food and Drug Administration (FDA) from its pre-Investigational New Drug meeting regarding DehydraTECH-CBD for…
Rain Therapeutics RAIN has completed patient enrolment in its Phase 3 MANTRA trial of its lead asset, milademetan for well-differentiated / dedifferentiated (WD/DD) liposarcoma (LPS). The MANTRA study is a…
The U.S. Food and Drug Administration (FDA) accepted for review ImmunityBio’s IBRX Biologics License Application (BLA) for its lead asset N-803 in the treatment of patients with BCG-unresponsive non-muscle-invasive bladder…
Turning Point Therapeutics TPTX has received positive feedback from the U.S. Food and Drug Administration (FDA) at a pre-New Drug Application (NDA) meeting completed in the second quarter. The pre-NDA meeting…
Pliant Therapeutics PLRX received Fast Track designation for its lead asset PLN-74809 from the U.S. Food and Drug Administration (FDA) for the potential treatment of primary sclerosing cholangitis (PSC). PLN-74809…