SEOUL, Jul. 25 (Korea Bizwire) — South Korean biopharmaceutical firm Samsung Bioepis Co. said Tuesday that its biosimilar drug Renflexis was launched in the United States following the approval of the U.S. Food and Drug Administration (FDA). In April, the FDA approved Renflexis — a biosimilar referencing Janssen Biotech, Inc.’s blockbuster immunology medicine Remicade — [...]
TEL-AVIV, Israel and RALEIGH, N.C., Jun. 13 (Korea Bizwire) — RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced the initiation of the promotion of [...]
RALEIGH, N.C, May 4 (Korea Bizwire) — It is a little known fact that 70% of medicines given to children have been studied only in adults. As a result, most drugs used to treat diseases in children are used off-label. While there are pediatric clinical trial regulations in place, testing drugs in children continues to [...]
DANVERS, Mass., May 4 (Korea Bizwire) — Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies, announced today the enrollment of the first patient in the Food and Drug Administration (FDA) approved prospective feasibility study, STEMI Door to Unloading (DTU) with Impella CP® system in acute myocardial infarction. This trial will focus on [...]
TEL-AVIV, Israel, Apr. 4 (Korea Bizwire) — RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced that the U.S. Food and Drug Administration (FDA) has [...]
MOUNTAIN VIEW, Calif., Feb. 1 (Korea Bizwire) — Vascular Dynamics, Inc., (VDI) a privately held medical device company developing novel solutions for the treatment of hypertension, today announces that the United States Food and Drug Administration (FDA) has approved the company’s application to participate in the Expedited Access Pathway (EAP) program for its MobiusHD® device [...]
SEOUL, Jan 19 (Korea Bizwire) – The U.S. Food and Drug Administration (FDA) has released its draft guidance on biosimilar interchangeability, a move that will allow South Korean bio-pharmaceutical firm Celltrion Inc. to increase its presence in the U.S. market, company officials said Thursday. The FDA unveiled the guidance Tuesday (local time) that recommends that [...]
TEL-AVIV, Israel, Jan. 11 (Korea Bizwire) — RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced that RHB-104 has been granted Qualified Infectious Disease Product (QIDP) designation [...]
ATLANTA, Dec. 15 (Korea Bizwire) — Femasys Inc., a developer of innovative medical devices for the women’s healthcare market, today announced that it has closed $40 million in Series C financing. The transaction was arranged by Salem Partners, a Los Angeles-based investment bank which also participated as a principal investor. The Series C syndicate included [...]
TEL-AVIV, Israel, Nov. 10 (Korea Bizwire) — RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) (“RedHill” or the “Company”), a biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced that it has concluded a positive Type B Meeting with the U.S. [...]