FDA – media

AZ’s Farxiga Gets FDA Priority Review For Heart Failure

AstraZeneca has got off to a strong start in 2020, with the FDA granting a fast review for its diabetes drug Farxiga in heart failure and China approving Lokelma for hyperkalemia.
- Source: https://scrip.pharmaintelligence.informa.com/SC141424/AZs-Farxiga-Gets-FDA-Priority-Review-For-Heart-Failure
- 1,412
- January 8, 2020
AstraZeneca Farxiga FDA Lokelma
Global Recall of CyPass Micro-Stent by Alcon

A micro-invasive surgical device named CyPass Micro-Stent used for the treatment of glaucoma was globally recalled by Alcon, a subsidiary of Novartis. The stent was supposed to be used in combination with cataract surgery but the company announced an immediate recall.
- Source: The Verdict
- 548
- September 3, 2018
Company Insight FDA medical device recall
Breakthrough Device Designation Granted to Digital Intervention for Alzheimer’s

A grave neurodegenerative disease like Alzheimer’s whose cure is still unknown can now be managed with Dthera Sciences’ DTHR-ALZ, a novel digital therapy device which has been bestowed with the prestigious Breakthrough Device designation by the FDA.
- Source: MobiHealthNews
- 1,336
- August 27, 2018
AI Alzheimer's disease FDA New Approvals
FDA Approved Eye Drop Oxervate to Treat Neurotrophic Keratitis

Neurotrophic Keratitis (NK) is a rare eye disorder that affects the corneal sensation leading to a loss in vision. Till date, only invasive surgeries and palliative treatments were available to treat the disease. But now, there is a major breakthrough in this regard since the US-FDA has approved the Italian company Dompé’s eye drop, Oxervate in order to treat NK.
- Source: FiercePharma
- 1,320
- August 27, 2018
FDA New Approvals rare eye disease
First Dual-Lead Nerve Stimulator for Pain Management gets FDA Nod

SPR Therapeutics’ single- and dual-lead peripheral nerve stimulation devices win FDA nod as minimally invasive, non-opioid alternatives to treat acute chronic, postoperative and post-traumatic pain when implanted for up to two months.
- Source: FiercePharma
- 1,299
- August 22, 2018
FDA medical device New Approvals
Bristol-Myers Squibb’s Opdivo Ensures a Lung Cancer Position

Bristol-Myers Squibb secured a standing in the small cell lung cancer domain making up for its slower growth in the non-small cell lung cancer market compared to its counterpart, Merck.
- Source: FiercePharma
- 1,209
- August 22, 2018
BMS cancer FDA New Approvals
FDA Grants Approval for Brainsway’s OCD-Treating TMS System

Obsessive-compulsive disorder (OCD) patients are now offered with a new treatment option as the FDA grants de novo approval for Brainsway’s deep transcranial magnetic stimulation (TMS) system.
- Source: Mass Device
- 1,098
- August 22, 2018
FDA medtech Mental health New Approvals
Xolair Gets FDA Approval for Food Allergy Treatment

Xolair of Novartis and Roche has been declared as a breakthrough therapy for food allergies including eggs, milk and peanuts by the Food and Drugs Administration (FDA).
- Source: FiercePharma
- 992
- August 15, 2018
FDA food allergies New Approvals
De-Novo Marketing FDA Approval for Natural Cycles’ Contraception App

The US-FDA (US- Food and Drugs Administration) announced on 13 August that it will permit the marketing of Natural Cycles’ contraception app in the US for pre-menopausal women aged 18 years and older.
- Source: MobiHealthNews
- 1,110
- August 14, 2018
contraception FDA New Approvals
Contraceptive Vaginal Ring; Annovera granted FDA Approval

Annovera (segesterone acetate and ethinyl estradiol vaginal system), a multi-use donut-shaped ring, was recently approved and presented to the Population Council by the FDA.
- Source: MDEdge
- 1,027
- August 13, 2018
contraception FDA New Approvals

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