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

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

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

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 [...]

Samsung Bioepis’ Renflexis Hits U.S.

Samsung Bioepis’ Renflexis Hits U.S.

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 — [...]

RedHill Biopharma Initiates Promotion of Donnatal® and EnteraGam® in the U.S.

RedHill Biopharma Initiates Promotion of Donnatal® and EnteraGam® in the U.S.

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 [...]

Abiomed Announces First Patient Enrolled in STEMI DTU Feasibility Study

Abiomed Announces First Patient Enrolled in STEMI DTU Feasibility Study

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 [...]

RedHill Biopharma Receives FDA Orphan Drug Designation for YELIVA® for the Treatment of Cholangiocarcinoma

RedHill Biopharma Receives FDA Orphan Drug Designation for YELIVA® for the Treatment of Cholangiocarcinoma

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 [...]

Vascular Dynamics’ Announces Expedited Access Pathway Designation by FDA for MobiusHD® to Accelerate US Access for Treatment of Resistant Hypertension

Vascular Dynamics’ Announces Expedited Access Pathway Designation by FDA for MobiusHD® to Accelerate US Access for Treatment of Resistant Hypertension

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 [...]