Lugano, Switzerland, June 8 (Korea Bizwire) - Helsinn, a Swiss pharmaceutical group focused on building quality cancer care and rare diseases products, today announced that on April 1, 2020 the U.S. Food and Drug Administration (FDA) completed the review of the Investigational New Drug (IND) application for TAS0953/HM06 and released a “Study May Proceed” letter for [...]
Zug, Switzerland, June 8 (Korea Bizwire) - Lupin is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to mexiletine hydrochloride for the treatment of myotonic disorders. Myotonic disorders are a group of heterogeneous, inherited, neuromuscular disorders characterized by a shared symptom called myotonia. Myotonia is an inability [...]
Amsterdam, the Netherlands, June 2 (Korea Bizwire – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that the US FDA has issued an Emergency Use Authorization (EUA) for Philips’ IntelliVue Patient Monitors MX750/MX850 and its IntelliVue Active Displays AD75/AD85, for use in the US during the COVID-19 health emergency [1]. These patient [...]
SEOUL, May 22 (Korea Bizwire) — South Korean molecular diagnostics firm Biocore Co. said Friday it has received approval from the U.S. Food and Drug Administration (FDA) for emergency use of its coronavirus test kit. Biocore said it has become the seventh South Korean COVID-19 test kit manufacturer that has garnered emergency use authorization (EUA) [...]
Amsterdam, the Netherlands, May 13 (Korea Bizwire) – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market a wide range of its ultrasound solutions for the management of COVID-19-related lung and cardiac complications. Handheld and portable [...]
Amsterdam, the Netherlands, April 24 (Korea Bizwire) – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, announced today that its Emergency Care and Resuscitation (ECR) business is resuming manufacturing and shipping of external defibrillators for the US, following notification from the US Food and Drug Administration (FDA) that the injunction prohibiting those activities [...]
SEOUL, April 22 (Korea Bizwire) — Seegene Inc., a major diagnostic assay maker in South Korea, said Wednesday that it has won an emergency approval from the U.S. health authority for its test kit for the new coronavirus that has infected more than 2.5 million around the globe. The U.S. Food and Drug Administration granted [...]
Ann Arbor, Mich., USA, April 2 (Korea Bizwire) — In early March 2020, Amarex Clinical Research LLC, an NSF International company, executed a rush submission of an emergency use Investigational New Drug (IND) application to add COVID-19 as a new indication for CytoDyn’s monoclonal antibody product, Leronlimab. The product is currently being tested for HIV [...]
SHANGHAI, China, March 30 (Korea Bizwire) — Junshi Biosciences (HKEX: 1877) today announced that the U.S. Food and Drug Administration (FDA) has recently granted Orphan Drug Designation (ODD) for toripalimab in combination with Pfizer’s axitinib for the treatment of patients with mucosal melanoma. Toripalimab is an anti-PD-1 monoclonal antibody developed by Junshi. Toripalimab received its [...]
VANCOUVER, British Columbia, March 13 (Korea Bizwire) — Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company is pleased to announce that is has filed its pre-IND (Investigational New Drug) meeting request with the U.S. FDA. This initiates formal communications with the U.S. FDA regarding development [...]