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Food & Drug Administration (FDA)

Anika touts Phase III data for Cingal knee therapy

May 22, 2017 By Sarah Faulkner

Anika Therapeutics

Anika Therapeutics (NSDQ:ANIK) touted data today from a Phase III trial for its Cingal hyaluronic acid-corticosteroid combination viscosupplement as a treatment for osteoarthritis-related knee pain. The data showed that treatment with Cingal yielded better immediate and short-term pain relief compared to hyaluronic acid alone and better pain and stiffness relief through 26 weeks compared to saline. […]

Filed Under: Clinical Trials, Featured, Food & Drug Administration (FDA), Pain Management, Pharmaceuticals, Regulatory/Compliance Tagged With: Anika Therapeutics Inc.

Intersect ENT updates on Sinuva steroid-releasing sinus implant

May 22, 2017 By Sarah Faulkner

Intersect ENT

Intersect ENT (NSDQ:XENT) said today that the FDA is slated to make a decision on its new drug application for the Sinuva steroid-releasing sinus implant by January 7, 2018. The Sinuva implant, which was previously called the Resolve implant, is placed during an in-office doctors appointment and is designed to be a treatment option for […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants, Otolaryngology Ear, Nose & Throat, Wall Street Beat Tagged With: Intersect ENT Inc.

ViaCyte looks to cell replacement therapy to cure Type I diabetes

May 22, 2017 By Sarah Faulkner

ViaCyte

ViaCyte said today that it will begin clinical trials of its novel islet cell replacement therapy in development as a potential cure for Type I diabetes, after landing regulatory wins from the FDA and Health Canada. The company’s PEC-Direct candidate delivers stem cell-derived pancreatic progenitor cells in a device that is designed to enable direct […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Funding Roundup, Stem Cells Tagged With: Juvenile Diabetes Research Foundation (JDRF), ViaCyte, W.L. Gore

FDA and NIH launch new clinical trial protocol writing tool

May 22, 2017 By Danielle Kirsh

By Stewart Eisenhart, Emergo Group US regulators at the Food and Drug Administration and the National Institutes of Health (NIH) have published a new writing tool for use in applying for regulatory approval to conduct clinical trials for medical devices and pharmaceuticals. Get the full story here at the Emergo Group’s blog. The opinions expressed […]

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

Medtech stories we missed this week: May 19, 2017

May 19, 2017 By Danielle Kirsh

missed medtech

From FDA clearances to touting study data, here are some medtech stories we missed this week but thought were still worth mentioning. 1. XpandOrtho wins FDA 510(k) clearance XpandOrtho announced in a May 17 press release that it has received FDA 510(k) clearance for its electronic soft tissue balancing instrument for total knee replacement surgery. The […]

Filed Under: Clinical Trials, Featured, Food & Drug Administration (FDA), Research & Development Tagged With: Body Vision Medical, Exactech Inc., Lombard Medical Technologies, medtech, NxThera Inc., Rivanna Medical, VisionSense, XpandOrtho

New FDA commish extends time for comments on off-label communication rules

May 19, 2017 By Sarah Faulkner

FDA

Under the agency’s new commissioner, Dr. Scott Gottlieb, the FDA has reportedly extended the time for comments in its review of off-label communication rules. In the past, Gottlieb has advocated for off-label uses of medical products, arguing that doctors are adequately trained to make decisions in the best interest of their patients. The FDA maintains […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance Tagged With: Capitol Hill

FDA proposes Conformity Assessment pilot

May 19, 2017 By Danielle Kirsh

By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have begun seeking stakeholder feedback for a proposed system to better evaluate registrants’ compliance with voluntary consensus standards. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]

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

Navigating the regulatory and development pathways for drug-device products

May 18, 2017 By Sarah Faulkner

David Lee began his path to CEO of Lumicell in 1999, when his wife was diagnosed with cancer. She passed away in 2003, while Lee was working in the semiconductor industry. He decided it was time for a career change. More than a decade later, Lee holds the corner office at a company that is […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Wall Street Beat Tagged With: cocoonbiotech, Ethicon, Lumicell, panthertherapeutics, Shire

Dr. Reddy’s liposomal doxorubicin wins FDA nod

May 17, 2017 By Sarah Faulkner

Dr. Reddy's Laboratories

Dr. Reddy’s Laboratories (NYSE:RDY) said today that the FDA approved its doxorubicin hydrochloride liposome injection for intravenous administration. The liposomal formulation is a therapeutic-equivalent generic version of the chemotherapeutic, Doxil. “This approval represents the 1st of its kind for Dr. Reddy’s in the complex depot injectables arena,” Alok Sonig, executive VP and head of the U.S. […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Dr. Reddy's Laboratories

Dr. Gottlieb’s first remarks to FDA staff

May 17, 2017 By Danielle Kirsh

FDA

Remarks by Scott Gottlieb, M.D. FDA All Hands Meeting May 15, 2017 Silver Spring, MD It’s an honor to be here today and to be taking on this responsibility with all of you. You realize how special our mission of consumer protection and public health promotion is when you explain what we do to the children […]

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

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