Industry News

- Read more about FDA grants rare pediatric disease designation to MediciNova’s MN-166 (ibudilast) for the treatment of Krabbe Disease
MediciNova, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to MN-166 (ibudilast) for treatment of Type 1 - Early Infantile Krabbe disease.
- Read more about FDA outlines cybersecurity recommendations for medical device manufacturers
The US Food and Drug Administration (FDA) issued a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health.
- Read more about Titan Pharmaceuticals and Braeburn Pharmaceuticals announce Fda advisory committee recommends approval of probuphine
Titan Pharmaceuticals, Inc. and partner Braeburn Pharmaceuticals announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) voted 12 to 5 in favor of approving Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction, in stable patients receiving 8mg or less per day of buprenorphine. The Committee’s vote followed presentation and discussion of data regarding Probuphine’s efficacy, safety, and risk-benefit profile. The New Drug Application (NDA) for Probuphine was resubmitted to the FDA in August 2015, and accepted by the FDA in September 2015. A target agency action date has been set for February 27, 2016.
- Read more about BENEPALI®, the First Etanercept Biosimilar Referencing Enbrel®, Approved in the European Union
The joint venture between Biogen and Samsung BioLogics, Samsung Bioepis, has been granted European Commission (EC) approval for BENEPALI® , an etanercept biosimilar referencing Enbrel®. BENEPALI has been granted marketing authorization in the European Union (EU) for the treatment of adults with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis. Biogen intends to make BENEPALI available for patients in the coming weeks.
- Read more about FDA Issues Complete Response Letter for KyndrisaTM for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
BioMarin Pharmaceutical Inc. announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter to the Company's New Drug Application (NDA) for KyndrisaTM (drisapersen) for the treatment of Duchenne muscular dystrophy (Duchenne) amenable to exon 51 skipping.
amenable to exon
- Read more about Five Prime Therapeutics Receives FDA Orphan Drug Designation for FPA008 in PVNS
Five Prime Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for FPA008 for the treatment of Pigmented Villonodular Synovitis (PVNS), a locally aggressive tumor of the synovium.
- Read more about Impax Receives Approval of EMVERM™ (mebendazole) Chewable Tablets, 100 mg
Impax Laboratories, Inc. announced that the United States Food and Drug Administration (FDA) has approved the Company's supplemental new drug application (sNDA) for EMVERM (mebendazole) 100 mg chewable tablets
- Read more about Gilead submits NDA to FDA for Chronic Hepatitis B drug
Gilead Sciences, Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tenofovir alafenamide (TAF) 25 mg, an investigational, once-daily treatment for adults with chronic hepatitis B virus (HBV) infection.
- Read more about Volpara Solutions Receives FDA Clearance for Volpara Density Maps
Volpara Solutions, the leading provider of automated breast density assessment and quantitative breast imaging tools, announced that it has received a new 510(k) clearance from the U.S. Food & Drug Administration (FDA) for Volpara Density Maps, a new solution designed to help radiologists address the requirement in the BI-RADS 5th Edition Atlas to provide “an overall assessment of the volume of attenuating tissues in the breast, to help indicate the relative possibility that a lesion could be obscured.”

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- Read more about Pluristem Receives U.S. FDA Clearance to Initiate Clinical Trial of PLX-R18
Pluristem Therapeutics Inc, a leading developer of placenta-based cell therapy products, announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application to begin its Phase I trial of PLX-R18 cells to treat incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT). The clinical trial is expected to begin in the first half of 2016.