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Food & Drug Administration (FDA)

Mylan shares down -3% after FDA rejects Advair generic

March 29, 2017 By Sarah Faulkner

Mylan

Shares in Mylan (NSDQ:MYL) dropped -3% to $40.46 apiece today after the FDA rejected its Abbreviated New Drug Application for the generic version of GlaxoSmithKline‘s (NYSE:GSK) Advair Diskus. The Canonsburg, Penn.-based company said it is “in the process of reviewing this response and will provide an update on its application as soon as practicable once it has […]

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

Trump FDA pick to recuse himself from agency decisions involving 20 companies

March 29, 2017 By Sarah Faulkner

FDA

Donald Trump’s nominee to head the FDA, Dr. Scott Gottlieb, reportedly told ethics officials at the Office of Government Ethics he plans to recuse himself for 1 year from agency decisions on more than 20 companies, including GlaxoSmithKline (NYSE:GSK) and Bristol-Myers Squibb (NYSE:BMY). Gottlieb has received millions of dollars for his roles as advisor, paid speaker […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceuticals, Policy, Regulatory/Compliance, Wall Street Beat Tagged With: Biogen Idec, Bristol-Myers Squibb Co., GlaxoSmithKline plc, Merck

This is not a test: RMAT designation goes live

March 27, 2017 By Danielle Kirsh

FDA

By: Peter Marks, M.D., Ph.D. The field of regenerative medicine encompasses a wide scope of innovative products including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and certain combination products using such therapies. Examples include genetically-modified cellular therapies, such as chimeric antigen receptor T-cells (CAR-T cells) and human tissues grown on scaffolds […]

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

The top medtech stories of early 2017

March 24, 2017 By Chris Newmarker

Donald Trump top medtech stories

The new Trump administration and Republican Congress – and all the accompanying change and uncertainty – is the major story for the medical device industry. But there are many other medtech stories worth noting from the first quarter of 2017. There was an FDA warning over Abbott’s Absorb bioresorbable stent, a continued spate of M&A deals, diabetes […]

Filed Under: Business/Financial News, Diabetes, Featured, Food & Drug Administration (FDA), Mergers & Acquisitions Tagged With: Abbott Laboratories, Absorb, Affordable Care Act, Diabetes, Donald Trump, Insulet, medtech, Obamacare, Omnipod

Trump proposes higher FDA fees for drug, medical device FDA registrants

March 23, 2017 By Danielle Kirsh

By Stewart Eisenhart, Emergo Group US Food and Drug Administration user fee increases in the Trump Administration’s proposed 2018 federal budget would disproportionately impact smaller medical device companies, as these firms make up the majority of the US medical device industry. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]

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

Facing pressure from pharma, FDA delays off-label promotion rule

March 20, 2017 By Sarah Faulkner

FDA

After pharmaceutical industry groups filed a petition against the FDA’s new off-label promotion rule, the federal watchdog agency said last week it would delay the rule’s implementation to March 19, 2018. The agency originally intended for the law to go into effect on March 21 this year. The rule would expand the evidence that the […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceuticals, Policy, Wall Street Beat

Medtech stories we missed this week: March 17, 2017

March 17, 2017 By Danielle Kirsh

The FDA awarded 510(k) clearance to a couple of medtech companies this week while others received tax breaks and incentives, including a local tax break for a $154 million Stryker R&D facility planned in Michigan. Here are some medtech stories we missed this week but thought were worth mentioning. 1. FirstRay wins FDA 510(k) clearance […]

Filed Under: Cardiovascular, Food & Drug Administration (FDA), Legal News, Research & Development Tagged With: Amend Surgical, Avita, CorVascular, FirstRay, Innovative Cardiovascular Solutions, medtech, millar, stryker

510(k) submissions to FDA declining

March 17, 2017 By Danielle Kirsh

By Stewart Eisenhart, Emergo Group The number of US-based medical device manufacturers submitting 510(k) premarket notification applications to the Food and Drug Administration has decreased over the past four years, according to a new Emergo study, while applications from European and Asian firms have increased. Get the full story here at the Emergo Group’s blog. […]

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

FDA proposes exempting 337 Class II devices from 510(k) requirements

March 16, 2017 By Danielle Kirsh

By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration (FDA) have proposed exempting hundreds of moderate-risk devices from 510(k) premarket notification requirements as the agency begins implementing components of the 21st Century Cures Act passed in late 2016. Get the full story here at the Emergo Group’s blog. The […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: blog, Emergo Group

FDA panel rules that benefits of Endo’s Opana opioid no longer outweigh risks

March 15, 2017 By Sarah Faulkner

Endo Pharmaceuticals

An FDA advisory panel ruled yesterday that the benefits of Endo Pharmaceutical‘s opioid painkiller, Opana ER, no longer outweigh its risks. The painkiller has been linked to a 2015 HIV outbreak in Indiana after people addicted to opioids shared needles while injecting Opana. The panel voted 18 to 8 that the drug’s benefits do not […]

Filed Under: Featured, Food & Drug Administration (FDA), Pain Management, Pharmaceuticals, Wall Street Beat Tagged With: Endo Pharmaceuticals

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