Cook Medical said it won FDA approval for a smaller-diameter version of its Zilver PTX peripheral drug-eluting stent. Bloomington, Ind.-based Cook said the approval for the 5mm diameter Zilver PTX makes it the first such stent up to 140mm that’s approved in the U.S. for vessels as small as 4mm. “We spend a lot of time […]
TCT 2018: Boston Scientific wins FDA nod for drug-eluting vascular stent
On the heels of positive study results at the 30th Transcatheter Cardiovascular Therapeutics meeting, Boston Scientific (NYSE:BSX) won FDA approval for its drug-eluting vascular stent system, Eluvia. The device, which is designed for the treatment of peripheral artery disease, uses a drug-polymer combination to deliver paclitaxel over the course of a year. “Over the past decade, we’ve […]
Teva wins FDA nod for migraine prevention drug
Teva (NYSE:TEVA) last week won FDA approval for its humanized monoclonal antibody, Ajovy, designed to prevent migraines. The treatment, which blocks the receptor for a protein that is linked to migraine pain, is available in quarterly and monthly-injection options. Amgen‘s (NSDQ:AMGN) competitive once-monthly product won FDA approval earlier this year. Teva studied Ajovy in two Phase […]
Genentech wins FDA nod for subcutaneous formulation of arthritis drug
Roche‘s (OTC:RHHBY) Genentech reported this week that the FDA approved the subcutaneous formulation of tocilizumab for the treatment of active systemic juvenile idiopathic arthritis in patients two years and older. The U.S. agency approved the intravenous formulation of Actemra for the same indication in 2011. Systemic juvenile idiopathic arthritis affects roughly 30,000 children in the U.S., according […]
FDA pushes back decision date for Acorda’s Parkinson’s drug
Acorda Therapeutics (NSDQ:ACOR) said today that the FDA pushed back its goal date for the agency’s review of Acorda’s inhaled levodopa Parkinson’s therapy. The FDA’s date to make a decision about Acorda’s Inbrija product was moved from Oct. 5, 2018 to Jan. 5, 2019. The Ardsley, N.Y.-based company said the extension is related to submissions […]
Teva wins FDA nod for sublingual film to treat opioid dependence
The FDA last week approved Teva Pharmaceuticals (NYSE:TEVA) Cassipa sublingual film as a maintenance treatment for opioid dependence. There are a number of brand name and generic versions of buprenorphine and naloxone therapies that are delivered via a sublingual film. Teva’s product contains 16 milligrams of buprenorphine and 4 milligrams of naloxone, bringing a new dosage […]
Cook, AcuityBio ink deal for lung cancer drug technology
Cook Biotech will collaborate with drug-delivery maker AcuityBio on Acuity’s lead lung cancer product, the companies said today. Acuity’s ABC103 will use Cook Biotech’s proprietary extracellular matrix (ECM) technology. ABC103 is a platform technology designed for localized, sustained drug delivery to prevent post-surgical lung cancer recurrence. It combines approved/ cleared surgical staple-line buttress, drug-eluting polymers and […]
New program with payors aims to accelerate patient access to medical devices
Scott Gottlieb, M.D. Advancing the public health means helping to make sure patients have access to safe, effective medical products. Access is a matter of public health. And our commitments to patients don’t stop at the time of a product’s approval. We take many steps to make sure products can be safely accessed in the […]
FDA warns of flesh-eating genital infection linked to diabetes drug
The FDA this week warned of serious flesh-eating bacterial infections, or necrotizing fasciitis, reported by patients taking sodium-glucose cotransporter-2 (SGLT2) inhibitors intended for treating type 2 diabetes. The federal watchdog said that between March 2013 and May 2018, 12 cases of Fournier’s gangrene, a rare but life-threatening bacterial infection of the tissue under the skin […]
J&J’s Janssen wins FDA nod for first non-chemo treatment for rare blood cancer
Johnson & Johnson‘s (NYSE:JNJ) Janssen division said today that it won new FDA approval for its Imbruvica, clearing it for use in treating the rare blood cancer Waldenström’s macroglobulinemia in combination with ritumixab. The approval expands the label for Imbruvica to include combination use with ritumixab, and represents “the first approved non-chemotherapy combination option for the […]
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