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Food & Drug Administration (FDA)

GSK dodges bullet after another generic Advair competitor is denied

May 11, 2017 By Sarah Faulkner

GlaxoSmithKline

GlaxoSmithKline (NYSE:GSK) will not likely face generic competition to its lung drug Advair in the US this year. Yesterday, the FDA denied the application for a 2nd generic competitor. Hikma Pharmaceuticals (LON:HIK) disclosed today that the FDA decided not to approve its version of the inhaled asthma treatment, due to “major” problems with the application. This comes […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: GlaxoSmithKline plc, hikmapharmaceuticals, Mylan

FDA approves first ALS treatment in over 2 decades

May 8, 2017 By Danielle Kirsh

radicava

The FDA recently announced that it has approved the drug Radicava (edaravone) to help treat patients who have amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. ALS is a progressive neurodegenerative disease that affects the nerve cells in the brain and spinal cord, according to the ALS Association. Motor neurons in the brain […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceuticals Tagged With: ALS, MT Pharma America

Medtech stories we missed this week: May 5, 2017

May 5, 2017 By Danielle Kirsh

missedmedtech0502

From Biomerics’s $38.5 million expansion in Salt Lake City to new study results and partnerships, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Biomerics opening new corporate HQ Biomerics announced in a May 1 press release that it is moving its corporate headquarters in Salt Lake City. The […]

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Regulatory/Compliance, Research & Development Tagged With: Accuray Inc., Biomerics, Glytec, medPhoton, medtech, Mevion Medical Systems, Neural Analytics, RAPS, Refocus

FDA OKs BioDelivery Sciences’ Bunavail opioid dependence film

May 2, 2017 By Sarah Faulkner

BioDelivery Sciences International

BioDelivery Sciences International (NSDQ:BDSI) said today that the FDA approved a supplemental new drug application for its Bunavail buprenorphine and naloxone buccal film. The revised indication allows patients to use the product to initiate buprenorphine treatment for opioid dependence. Induction is the initial process by which a patient transitions from abusing an opioid to buprenorphine […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: BioDelivery Sciences International

GE Healthcare wins FDA nod for Visipaque coronary CT angiography injection

May 2, 2017 By Sarah Faulkner

General Electric logo

GE Healthcare (NYSE:GE) said today that it won an indication approval from the FDA for its Visipaque injection imaging agent. The 320 milligram iodine per milliliter injection is an iso-osmolar agent that the federal watchdog approved for use in coronary computed tomography angiography. The new indication allows doctors to image coronary arteries of patients to help […]

Filed Under: Cardiovascular, Diagnostics, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Vascular Tagged With: GE Healthcare

Working to raise awareness and reduce health disparities

May 2, 2017 By Danielle Kirsh

FDA

By: Jonca Bull, M.D. April is National Minority Health Month and this year’s theme is “Bridging Health Equity Across Communities.” FDA’s Office of Minority Health (OMH) is committed to the HHS mission of advancing health equity, and our office works year-round to advance FDA’s message of ensuring the safety and efficacy of our nation’s food […]

Filed Under: Food & Drug Administration (FDA) Tagged With: blog, FDA Voice

Medtronic wins FDA nod for Resolute Onyx drug-eluting stent

May 1, 2017 By Sarah Faulkner

Medtronic's Resolute Onyx

Medtronic (NYSE:MDT) said today that the FDA approved its Resolute Onyx drug-eluting stent. The Fridley, Minn.-based company touted its device as the 1st stent formed by a sinusoidal wave of cobalt alloy wire. The company incorporated a radiopaque inner core within the wire to boost visibility, according to Medtronic. The stent also features thin struts and a polymer […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Stents, Vascular Tagged With: Medtronic

Medtech stories we missed this week: April 28, 2017

April 28, 2017 By Danielle Kirsh

missedmedtechMD

From FDA and Health Canada approvals to joint ventures, here are medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Joimax Endovapor 2 Joimax announced in an April 26 press release that it has received FDA 510(k) clearance to market its Endovapor 2 Multi-Radio Frequency System. The device generates […]

Filed Under: Clinical Trials, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Research & Development Tagged With: Anaconda Biomed, Creganna Medical, Eclipse Aesthetics, Joimax, Mederi Therapeutics, medtech, Millennium Medical Technologies, SiBone, Theraclion

Nordisk wins label update for weight loss drug-device combo

April 27, 2017 By Sarah Faulkner

Novo Nordisk

Novo Nordisk (NYSE:NVO) said today that the FDA approved an updated label for its Saxenda liraglutide weight loss medicine. The therapy’s new label will include data showing that half of patients who received Saxenda and lost at least 5% of their weight after 56 weeks maintained their weight loss for 3 years. The update is based […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Wall Street Beat Tagged With: Novo Nordisk

Alnylam, The Medicines Co., detail Phase III trial for RNA-based heart drug

April 26, 2017 By Sarah Faulkner

anatomical heart

The Medicines Co. (NSDQ:MDCO) and Alnylam Pharmaceuticals (NSDQ:ALNY) said today that they’ve reached a deal with the FDA over a Phase III trial for the companies’ RNA-based cholesterol-lowering drug, inclisiran. If approved, it would be the 1st RNA-interference therapy on the market. The drug is a part of a new group of drugs called PCSK9 […]

Filed Under: Cardiovascular, Clinical Trials, Featured, Food & Drug Administration (FDA), Wall Street Beat Tagged With: Alnylam Pharmaceuticals, Amgen, Regeneron, The Medicines Co.

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