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Update — US FDA Approves Invivoscribe LeukoStrat CDx FLT3 Mutation Assay as CDx and Astellas Drug XOSPATA (gilteritinib fumarate) for Treatment of AML Patients in the US

SAN DIEGO, Nov. 29 (Korea Bizwire) — Invivoscribe is pleased to announce FDA approval of both the LeukoStrat CDx FLT3 Mutation Assay and the Astellas drug, XOSPATA (gilteritinib fumarate), for treatment of FLT3 positive refractory/relapse acute myeloid leukemia (AML) patients in the US. Further, the Japanese MHLW has confirmed national reimbursement for the LeukoStrat CDx [...]

Neuralstem Announces NSI-189 Granted Orphan Drug Designation from the U.S. FDA for the Treatment of Angelman Syndrome

GERMANTOWN, Md., Aug. 9 (Korea Bizwire) — Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell technology, today announced that the U.S. Food and Drug Administration has granted orphan drug designation to NSI-189 for the treatment of Angelman syndrome. “Angelman Syndrome is a rare disease [...]

Celixir Announces US FDA Approval of the IND Application for Cell Therapy Heartcel

Stratford-upon-Avon, UK, Jun. 8 (Korea Bizwire) – Celixir, a privately owned company discovering and developing life-saving advanced therapies, announces that the US Food and Drug Administration (FDA) has approved its Investigational New Drug application (IND) for HeartcelTM, its immuno-modulatory progenitor (iMP) cell therapy for the treatment of adult heart failure. Celixir announced in January the approval [...]

Invivoscribe Submits Pre-Market Approval Application in Japan and Panel Track Supplement in the US to Screen Acute Myeloid Leukemia (AML) Patients for FLT3 Mutations

SAN DIEGO, May 8 (Korea Bizwire) — Invivoscribe Technologies, Inc. announced today that they have submitted to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) and the US Food and Drug Administration (FDA) product registrations based on the ongoing Phase III CL-0301 ADMIRAL study evaluating gilteritinib for the treatment of FLT3 mutation-positive (FLT3mut+) relapsed or refractory [...]

SpeeDx Receives FDA Clearance for Mycoplasma Genitalium Product

SYDNEY, Australia, Apr. 19 (Korea Bizwire) — SpeeDx’s ResistancePlus® MG Positive Control kit has now been listed with the US Food and Drug Administration (FDA) for sale in the United States through the company’s recently incorporated US entity, SpeeDx Inc. The announcement coincides with the FDA registration of the Australian parent company – SpeeDx Pty [...]

S. Korean Drug Firms Setting Sights on U.S. Market

SEOUL, Mar. 21 (Korea Bizwire) — South Korean drug companies are ramping up their efforts to tap into the United States, the world’s largest pharmaceutical market, industry sources said Wednesday. Leading the pack is top pharmaceutical firm Yuhan Corp. that has recently established a wholly owned subsidiary, named Yuhan USA, in San Diego. Yuhan said [...]

Cause of Ewha U. Hospital Newborn Deaths Cast into Doubt by FDA Doc

Seoul, Jan. 12 (Korea Bizwire) — New details have emerged regarding the deaths of four premature infants at Ewha Womans University Medical Center’s neonatal intensive care unit, which paints not only the medical staff involved but the Ministry of Food and Drug Safety, the National Forensic Service, and other health authorities in a damning light. [...]

RedHill Biopharma and IntelGenx Submit New Drug Application to FDA for RIZAPORT® for Migraines

TEL-AVIV, Israel and RALEIGH, N.C., Nov. 1 (Korea Bizwire) — RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, together with IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (“IntelGenx”), a leading [...]

Abiomed Receives FDA PMA Approval for Impella RP® for Right Heart Failure

DANVERS, Mass., Sept. 20 (Korea Bizwire) — Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, today announced it has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella RP® heart pump. Culminating from five years of research, this approval follows the prior FDA Humanitarian Device Exemption [...]

RedHill Biopharma Announces U.S. Commercialization Agreement for FDA-Approved GI Product Esomeprazole Strontium Delayed-Release Capsules

TEL-AVIV, Israel and RALEIGH, N.C., Aug. 17 (Korea Bizwire) — RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced that it has entered into a commercialization [...]