Search Results for “FDA” – Page 68 – media

Heart Study app could be Apple’s first FDA-cleared product

The Apple Heart Study — which began enrollment at the end of November — has now begun data collection, with participants receiving prompts over the weekend to sign informed consent documents and initiate data collection. That document also reveals some new details about how Apple plans to use data collected during the study.
- Source: MobiHealthNews
- 1,028
- February 7, 2018
App Apple Company Insight FDA mHealth
Empatica’s consumer-facing epileptic seizure-detecting wearable gets FDA clearance

Emaptica's Embrace, the consumer-facing wearable for epileptic seizure detection, received 510(k) clearance from the FDA last month. The wearable, which has already been used in clinical trials by pharma company Sunovion, has a long history that's led it up to this milestone.
- Source: MobiHealthNews
- 754
- February 6, 2018
digital health epilepsy medical device New Approvals
Ferring’s ZOMACTON® (somatropin) for Injection Receives FDA Approval to Treat Growth Hormone Deficiency in Adults

Administration (FDA) has approved ZOMACTON® (somatropin) for Injection 5 mg and 10 mg recombinant human growth hormone (GH) indicated for replacement of GH in adults with GH deficiency.
- Source: medindia.net
- 621
- February 5, 2018
FDA GH deficiency growth hormone ZOMACTON®
FDA Clears UC Davis Startup’s Polymer to Aid Bone Regrowth

Molecular Matrix Inc. invented a synthetic bone void filler, Osteo-P, that can help injured bones regrow.
- Source: ODT
- 600
- February 1, 2018
bone FDA medical device
Enzychem Lifesciences Announces the FDA Orphan Drug Designation Granted to EC-18 on Acute Radiation Syndrome (ARS)

Enzychem Lifesciences, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to EC-18 for the treatment of Acute Radiation Syndrome (ARS).
- Source: china-pharmacy
- 590
- February 1, 2018
ARS EC-18 FDA Orphan Drug Designation rare diseases
FDA Calls Roche’s Autism Drug a Breakthrough

An experimental Roche drug designed to improve social interaction in people with autism scored the U.S. Food and Drug Administration’s Breakthrough Therapy Designation.
- Source: Biospace
- 715
- January 31, 2018
autism New Approvals
FDA steps up efforts at bringing about medical device cyber security

It is a disturbing, but true fact that medical devices are hacked. Medical devices have inbuilt software, and hackers try to breach this. Medical device cybersecurity is thus critical, because lack of it can bring harm to patients who use medical devices that come with software built into them.
- Source: COMPLIANCE4ALL14
- 631
- January 31, 2018
cybersecurity FDA medical device Policy
Advanced Accelerator Applications Receives FDA Approval for Lutathera® for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Novartis AG (NYSE: NVS) today announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and Drug Administration (FDA) approval of its new drug application (NDA) for Lutathera® (lutetium Lu 177 dotatate*) for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors, in adults.
- Source: Novartis
- 485
- January 29, 2018
FDA GEP-NETs Lutathera® New Approvals
FDA to expedite release of recall information

When the FDA identifies that a product it regulates violates the law, it protects the public by working with the manufacturer and distributors to facilitate the product’s recall (i.e., removal from the marketplace or product correction). Among other actions, FDA assures that the public is warned when products present the most significant public hazards, including those recalls associated with an outbreak.
- Source: Mass Device
- 647
- January 22, 2018
Consumer Healthcare FDA Policy
Novartis granted US FDA Priority Review for Kymriah(TM) (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL

Novartis today announced that its supplemental Biologics License Application (sBLA) for KymriahTM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT) has been accepted by the US Food and Drug Administration (FDA) for Priority Review.
- Source: Novartis
- 400
- January 18, 2018
DLBCL New Approvals sBLA

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