USFDA

- Read more about Pfizer commends the FDA advisory committee’s vote to approve proposed Biosimilar Infliximab
Pfizer Inc. commends recommendation by the United States (U.S.) Food and Drug Administration’s (FDA) Arthritis Advisory Committee to approve the investigational biosimilar infliximab (CT-P13) across all eligible indications by a vote of 21 to three.
- Read more about Spectranetics get FDA 510(k) clearance for bridge™ Occlusion Balloon
Spectranetics Corporation announced U.S. Food and Drug Administration (FDA) Premarket Notification 510(k) clearance of the Bridge Occlusion Balloon for temporary vessel occlusion in cardiac lead extraction procedures.
- Read more about CTI BioPharma announces FDA Impose Partial Clinical Hold on Pacritinib IND
CTI BioPharma Corp. announced that the Company received written communication from the U.S. Food and Drug Administration (FDA) on February 4, 2016, that the FDA has placed a partial clinical hold on the clinical studies being conducted under the Company's Investigational New Drug ("IND") application for pacritinib. This clinical hold impacts part of the clinical work currently being conducted under the IND and will also affect planned clinical trials.
- Read more about FDA cleared Sangamo BioSciences IND application For ZFN-Mediated genome editing treatment Of MPS I
Sangamo BioSciences, Inc., the leader in therapeutic genome editing, announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for SB-318, a single treatment strategy intended to provide a life-long therapy for Mucopolysaccharidosis Type I (MPS I).
- Read more about Promius Pharma™ receives FDA approval for Sernivo (betamethasone dipropionate) Spray, 0.05%
Dr. Reddy’s announced that its US subsidiary, Promius PharmaTM, has received approval for Sernivo™ (betamethasone dipropionate) Spray, 0.05% from the U.S. Food and Drug Administration (FDA).
- Read more about US FDA accepts for review Otsuka and Lundbeck's sNDA filing for labeling update of Rexulti® (brexpiprazole)
H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental.
- Read more about Vertex receives complete response letter from U.S. FDA for Use of KALYDECO® (ivacaftor)
Vertex Pharmaceuticals announced that it received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for the use of KALYDECO® (ivacaftor) in people with cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The FDA determined that it cannot approve the application in its present form. Vertex plans to meet with the FDA to determine an appropriate path forward.
- Read more about Vizient, Inc. endorses the FDA’s Biosimilars approval pathway
Vizient, Inc. has sent a letter to the Food and Drug Administration’s (FDA) Arthritis Advisory Committee endorsing the continued implementation of the U.S. biosimilar pathway. On February 9, 2016, the committee is scheduled to hold an advisory hearing on an application for a biosimilar version of infliximab, currently only available as the branded biologic Remicade® (Janssen Biotech).
- Read more about Dr.Reddy's Sernivo spray gets USFDA nod
Indian drug major Dr.Reddy's Laboratories Ltd on Monday said its wholly owned US subsidiary Promius Pharma has got the USFDA for a spray to treat plaque psoriasis.

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- Read more about U.S. FDA approves expanded Use of Bristol-Myers Squibb’s Daklinza (daclatasvir)
Bristol-Myers Squibb’s announced that Daklinza™ (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3.