Sunday , June 25 2017
Home / FDA News

FDA News

Genentech’s Rituxan Hycela Receives FDA Approval for Treatment of Certain Blood Cancers

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved RITUXAN HYCELA™ (rituximab and hyaluronidase human) for subcutaneous (under the skin) injection for the treatment of adults with the following blood cancers: previously untreated and relapsed or …

Read More »

FDA Rejects Pfizer’s BLA for Proposed Epoetin Alfa Biosimilar

NEW YORK, N.Y., June 22 – Pfizer Inc. (NYSE:PFE) today announced that it has received a Complete Response Letter (CRL) from the United States (U.S.) Food and Drug Administration (FDA) regarding the company’s Biologics License Application (BLA) for its proposed epoetin alfa biosimilar. This CRL relates to matters noted in …

Read More »

FDA Approves Novartis’ Combination Targeted Therapy for BRAF V600E Mutant Metastatic NSCLC

Basel, June 22, 2017 – Novartis today announced the US Food and Drug Administration (FDA) approval of Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express the BRAF V600E mutation. The FDA granted Tafinlar + Mekinist Breakthrough Therapy designation …

Read More »

FDA Accepts Amgen’s sBLA to Expand Approval of Xgeva to Include Multiple Myeloma Patients

THOUSAND OAKS, Calif., June 19, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the XGEVA® (denosumab) supplemental Biologics License Application (sBLA) that seeks to expand the currently approved indication for the prevention of fractures and other skeletal-related events in patients …

Read More »

FDA Expands Approval of Ipsen’s Dysport for the Treatment of Lower Limb Spasticity in Adults

BASKING RIDGE, N.J.–(BUSINESS WIRE)–Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen SA (Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that the U.S. Food and Drug Administration (FDA) has expanded the approved use of Dysport®(abobotulinumtoxinA) for injection for the treatment of spasticity in adults, based on its supplemental Biologics License Application (sBLA) …

Read More »

FDA Approves Darzalex in Combination with Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

HORSHAM, Pa., June 16, 2017 /PRNewswire/ — Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the immunotherapy DARZALEX® (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide …

Read More »

FDA Grants Orphan Drug Designation to RASRx’s Duchenne Muscular Dystrophy Drug

NEWPORT BEACH, Calif.–(BUSINESS WIRE)–RASRx announced today that the United States Food and Drug Administration (FDA) has granted an Orphan Drug Designation (ODD) for its compound RASRx1902 for the treatment of Duchenne Muscular Dystrophy. RASRx1902 is an oral therapy that has shown positive effects on muscle function in animal models of …

Read More »

FDA Grants Breakthrough Therapy Designation to Omeros’ MASP-2 Inhibitor for the Treatment of IgA Nephropathy

SEATTLE–(BUSINESS WIRE)–Omeros Corporation (NASDAQ: OMER) today announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to OMS721 for the treatment of Immunoglobulin A (IgA) nephropathy. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway …

Read More »

FDA Rejects Coherus’ Application for Proposed Biosimilar to Amgen’s Neulasta

REDWOOD CITY, Calif., June 12, 2017 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced that the U.S. Food and Drug Administration (“FDA”) has issued a complete response letter (“CRL”) for its biologics license application (“BLA”) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, under the 351(k) pathway. The CRL primarily …

Read More »

FDA Accepts Bioverativ’s IND Application for its Hemophilia A Drug BIVV001

WALTHAM, Mass.–(BUSINESS WIRE)–Bioverativ (NASDAQ: BIVV), a global biotechnology company focused on the discovery, development and commercialization of innovative therapies for hemophilia and other rare blood disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for BIVV001 (also known as …

Read More »