BioSpace News Archive

Vanda Pharmaceuticals Inc. announced the notice of opportunity for an FDA hearing on Vanda’s Supplemental New Drug Application for HETLIOZ® to treat jet lag disorder.

Genexine (KOSDAQ: 095700), today announced that GX-188E, its first-in-class proprietary DNA vaccine, demonstrated potent efficacy and favorable safety in patients with advanced cervical cancer in a phase 2 study when given in combination with KEYTRUDA® (pembrolizumab), MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy.

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) announced today that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) voted (7 yes votes and 2 no votes) that the available evidence of effectiveness is sufficient to support approval of AMX0035.

InxMed Co., Ltd today announced the dosing of the first patient in its Phase 2 pivotal study evaluating IN10018, a highly potent and selective oral inhibitor of focal adhesion kinase (FAK), in combination with pegylated liposomal doxorubicin (PLD) in patients with platinum-resistant recurrent ovarian cancer (PROC).

Medtronic plc, a global leader in healthcare technology, confirmed its participation in the following September 2022 investor conferences.

Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that management will participate in the H.C. Wainwright 24th Annual Global Investment Conference to be held September 12-14, 2022.