Category Archives: Approvals

Achaogen Plans for Near-Term Sale Using Structured Process Through Chapter 11 of the U.S. Bankruptcy Code

  Bidding process and auction projected to conclude June 2019 SOUTH SAN FRANCISCO, Calif., April 15, 2019 (GLOBE NEWSWIRE) — Achaogen, Inc. (Nasdaq: AKAO), a biopharmaceutical company developing and commercializing innovative antibacterial agents to address multi-drug resistant (MDR) gram-negative infections, announced today that it has filed a voluntary petition under Chapter 11 of the Bankruptcy […]

Polyphor’s antibiotic murepavadin receives US FDA Qualified Infectious Disease Product designation in four new indications

Polyphor’s antibiotic murepavadin receives US FDA Qualified Infectious Disease Product designation in four new indications Polyphor AG (SIX: POLN) today announced that the US Food and Drug Administration (FDA) has designated murepavadin as a Qualified Infectious Disease Product (QIDP) in four additional indications; hospital-acquired bacterial pneumonia, acute bacterial skin and skin structure infection, bloodstream infection […]

Motif Bio Submits NDA for iclaprim

NEW YORK, June 14, 2018 (GLOBE NEWSWIRE) — Motif Bio plc (AIM:MTFB) (NASDAQ:MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced the completion of its rolling submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for iclaprim, a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure […]

LK-01 Granted Orphan Drug Designation by the U.S. FDA for Acute Myeloid Leukemia

BARCELONA, Spain – Leukos Biotech, a spin-off company founded by the Barcelona based Jose Carreras Leukaemia Research Institute and supported by VCF Inveready, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for LK-01, a product based on Apomorphine, for the treatment of Acute Myeloid Leukemia. Acute Myeloid Leukaemia (AML) is […]