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Cases of Encephalopathy Force the FDA to Place Clinical Hold on Studies of Bellicum’s Lead Candidate BPX-501

HOUSTON, Jan. 30, 2018 (GLOBE NEWSWIRE) — Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, today announced that the Company has received notice from the U.S. Food and Drug Administration (FDA) that U.S. studies of BPX-501 have been placed on a clinical hold following three …

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FDA Accepts Theravance and Mylan’s NDA for Revefenacin for the Treatment of Adults with COPD

DUBLIN and HERTFORDSHIRE, England and PITTSBURGH, Jan. 29, 2018 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) and Mylan N.V. (NASDAQ, TASE: MYL) (“Mylan”) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companies’ recently submitted New Drug Application (NDA) for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA). If approved, revefenacin would be the …

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FDA Approves First-Ever JAK2 Test for Use in Diagnosis of Additional Myeloproliferative Neoplasms

Hilden, Germany, and Germantown, Maryland, January 23, 2018 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today that it has received clearance for its ipsogen JAK2 RGQ PCR Kit (ipsogen JAK2 assay) from the U.S. Food and Drug Administration (FDA) for additional use in the diagnosis of all myeloproliferative neoplasms (MPNs), which are …

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FDA Grants Fast Track Status to Sobi’s Investigational MPS IIIA Drug

Swedish Orphan Biovitrum AB (publ) (Sobi™) announces that the FDA has issued a Study may proceed letter for the first study in humans, thereby accepting the investigational new drug (IND) application for the drug candidate SOBI003. In addition, SOBI003 was granted Fast Track status by the FDA. SOBI003 is a …

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BERG’s Investigational Pancreatic Cancer Drug Receives Orphan Drug Designation from the FDA

BOSTON, Jan. 22, 2018 /PRNewswire/ — BERG, a Boston-based biopharmaceutical company that merges biology with technology to map the nature of diseases, today announced the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to the Company’s leading product candidate BPM31510, for the treatment of pancreatic cancer.  “The FDA’s …

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Orphazyme’s Arimoclomol Receives FDA Rare Pediatric Disease Designation for Niemann-Pick disease Type C

Copenhagen, Denmark, January 19, 2018 – Orphazyme A/S, a Danish biotech company listed on Nasdaq Copenhagen (TICKER: ORPHA.CO), with a late-stage, orphan-drug pipeline, today announced that arimoclomol has been granted rare pediatric disease designation by the US Food and Drug Administration (FDA) for the treatment of Niemann-Pick disease Type C (NPC). …

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QIAGEN Receives FDA Approval to Expand Use of EGFR Test in Non-Small Cell Lung Cancer

Germantown, Maryland, and Hilden, Germany, January 18, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has approved a PMA supplement extending the indications for use of QIAGEN’s therascreen® EGFR RGQ PCR Kit as a companion diagnostic to guide the use …

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FDA Approves Addition of Overall Survival Data to Kyprolis Label

THOUSAND OAKS, Calif., Jan. 17, 2018 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for KYPROLIS® (carfilzomib). Data …

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FDA Grants Priority Review to Novartis’ Kymriah for Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Basel, January 17, 2018 – Novartis today announced that its supplemental Biologics License Application (sBLA) for KymriahTM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT) has …

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Centrexion Therapeutics’ CNTX-4975 Receives Fast Track Designation from the FDA for Treatment of Knee Osteoarthritis Pain

BOSTON–(BUSINESS WIRE)–Centrexion Therapeutics Corporation, a company focused on developing non-opioid, non-steroidal therapeutics for the treatment of chronic pain, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CNTX-4975 for the treatment of pain associated with knee osteoarthritis. CNTX-4975, Centrexion’s Phase 3 ready lead therapy, is a …

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