Industry News

- Read more about Lilly and Incyte announce submission of NDA to FDA for oral once-daily Baricitinib
Eli Lilly and Company and Incyte Corporation announced that Lilly has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of oral once-daily baricitinib for the treatment of moderately-to-severely active rheumatoid arthritis (RA).
- Read more about Zogenix receives fast track designation from FDA for development of ZX008 in Dravet Syndrome
Zogenix Inc. received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the development program for the Company’s investigational product, ZX008, as a treatment of seizures associated with Dravet syndrome, a rare and catastrophic form of childhood epilepsy.
- Read more about Edwards Receives FDA approval For expanded indication study Of SAPIEN 3 valve
Edwards Lifesciences Corporation, the global leader in patient-focused innovations for structural heart disease and critical care monitoring, announced U.S. Food and Drug Administration approval for an expanded indication study of its most advanced transcatheter aortic heart valve, the Edwards SAPIEN 3 valve. The investigational device exemption (IDE) study will enroll elderly patients with severe, symptomatic aortic stenosis (AS) who have been determined by a heart team to be at low risk for mortality if they were to undergo surgical aortic valve replacement.
- 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The US Food and Drug Administration (FDA) issued a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the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