FDA – Page 11 – media

Final FDA Rule Requires Medical Device Trials Outside US to Conform to GCP

The US Food and Drug Administration (FDA) on Tuesday finalized a rule that requires medical device clinical investigations conducted outside the US to flexibly conform with good clinical practice (GCP) standards.
- Source: Regulatory Affairs Professionals Society
- 637
- February 24, 2018
FDA medical device Policies
Novartis receives FDA approval for Cosentyx® label update to include moderate to severe scalp psoriasis

Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Cosentyx® (secukinumab), the first interleukin-17A (IL-17A) antagonist approved to treat moderate to severe plaque psoriasis.1 The updated label includes Cosentyx data in moderate to severe scalp psoriasis – one of the difficult-to-treat forms of the disease, which affects approximately half of all psoriasis patients.1-3 The label update is effective in the US immediately, and is based on the proven efficacy and consistent safety profile of Cosentyx from a dedicated Phase III scalp psoriasis trial.6
- Source: pharma.us.novartis
- 548
- February 13, 2018
Cosentyx® FDA New Approvals Scalp psoriasis
Sage Therapeutics Receives FDA Breakthrough Therapy Designation for SAGE-217 for the Treatment of Major Depressive Disorder

Sage Therapeutics (SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to SAGE-217 for the treatment of major depressive disorder (MDD). This is the second Breakthrough Therapy designation granted to Sage since 2016.
- Source: finance.yahoo
- 746
- February 12, 2018
biopharmaceutical FDA major depressive disorder New Approvals
Stanford spin-out Zenflow raises $31M to join the megamarket for enlarged prostate

A San Francisco, California-based medical device startup, Zenflow, has announced a $31.4 million Series A financing round to further its minimally-invasive approach to treating benign prostatic hyperplasia (BPH) or enlarged prostate.
- Source: MedCityNews
- 723
- February 11, 2018
FDA financing Market Views prostate
Kinsa launches QuickCare, an FDA-cleared wireless connected thermometer

Smart thermometer and connected health company Kinsa has launched a new wireless version of its device, called Kinsa QuickCare, after securing FDA clearance last month.
- Source: MobileHealthNews
- 874
- February 11, 2018
Company Insight digital health FDA mHealth
SIGA Technologies Announces FDA Accepts NDA and Grants Priority Review for Oral TPOXX to Treat Smallpox

SIGA Technologies, Inc. (SIGA) (OTCMKTS:SIGA), a health security company specializing in the development and commercialization of solutions for serious unmet medical needs and biothreats, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for its oral formulation of TPOXX® (tecovirimat).
- Source: investor.siga
- 602
- February 9, 2018
DNA FDA New Approvals TPOXX
Another Day, Another Breakthrough Tag for GlaxoSmithKline’s Bexsero

GlaxoSmithKline’s meningitis B vaccine Bexsero is in a class all by itself when it comes to snagging the Breakthrough Therapy Designation from the U.S. Food and Drug Administration(FDA).
- Source: biospace
- 583
- February 9, 2018
Bexsero FDA GSK meningitis B vaccine
FDA Calls Bay Area Zogenix’s Dravet Syndrome Drug a Breakthrough

Zogenix Announces Receipt of FDA Breakthrough Therapy Designation for ZX008 in Dravet Syndrome.
- Source: Biospace
- 499
- February 8, 2018
Dravet syndrome FDA New Approvals ZX008
AMAG Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application (sNDA) for Feraheme® (ferumoxytol injection)

AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has approved its application to broaden the existing label for Feraheme® (ferumoxytol injection) beyond the current chronic kidney disease (CKD) indication to include all eligible adult Iron Deficiency Anemia (IDA) patients who have intolerance to oral iron or have had unsatisfactory response to oral iron.
- Source: Amagpharma
- 691
- February 8, 2018
chronic kidney disease FDA Feraheme New Approvals
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
- 1,036
- February 7, 2018
App Apple Company Insight FDA mHealth

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