FDA Approvals News

Latest fda approvals news, reviewed by pharmacists.

FDA Approvals articles

'Artificial Pancreas' ApprovedFDA Approvals

'Artificial Pancreas' Approved

Medtronic's MiniMed 670G System approved for type 1 diabetes

October 3, 2016·1 min read
Three Rare Diseases Get New Treatment OptionFDA Approvals

Three Rare Diseases Get New Treatment Option

Ilaris (canakinumab) approved to treat three rare conditions

September 29, 2016·1 min read
Green Light for Biosimilar to HumiraFDA Approvals

Green Light for Biosimilar to Humira

Amjevita (adalimumab-atto), from Amgen, approved to treat multiple inflammatory diseases

September 27, 2016·1 min read
A New Rx for Immune DisordersFDA Approvals

A New Rx for Immune Disorders

Shire's Cuvitru (immune globulin) approved to treat primary immunodeficiency

September 21, 2016·1 min read
Duchenne Muscular Dystrophy Rx ApprovedFDA Approvals

Duchenne Muscular Dystrophy Rx Approved

Exondys 51 (eteplirsen) approved to treat Duchenne muscular dystrophy

September 19, 2016·1 min read
A New Rx to Prevent Heart Attack and StrokeFDA Approvals

A New Rx to Prevent Heart Attack and Stroke

Yosprala (aspirin and omeprazole) approved for heart attack, stroke prevention

September 18, 2016·1 min read
There's a New Vaccine This Flu SeasonFDA Approvals

There's a New Vaccine This Flu Season

Afluria quadrivalent flu vaccine approved by FDA

September 3, 2016·1 min read
FDA Approves First Biosimilar Etanercept FDA Approvals

FDA Approves First Biosimilar Etanercept

Sandoz's Erelzi (etanercept-szzs) approved to treat several inflammatory diseases

September 1, 2016·1 min read
Lisinopril Becomes a LiquidFDA Approvals

Lisinopril Becomes a Liquid

Liquid lisinopril formulation Qbrelis gains FDA approval

August 9, 2016·1 min read
A Four-in-One Hit to Hep CFDA Approvals

A Four-in-One Hit to Hep C

Viekira XR approved as once-daily treatment for hepatitis C

August 1, 2016·1 min read
New Type 2 Diabetes Rx Gets Green LightFDA Approvals

New Type 2 Diabetes Rx Gets Green Light

Sanofi's Adlyxin (lixisenatide) approved to treat type 2 diabetes

July 28, 2016·1 min read
New Option for Opioid-Induced ConstipationFDA Approvals

New Option for Opioid-Induced Constipation

Relistor (methylnaltrexone bromide) approved as a tablet to treat opioid-induced constipation

July 26, 2016·1 min read
Anesthesia Through the NoseFDA Approvals

Anesthesia Through the Nose

Kovanaze (tetracaine and oxymetazoline) can replace needles for dental anesthesia

July 26, 2016·1 min read
Once Daily Weight Loss Rx ApprovedFDA Approvals

Once Daily Weight Loss Rx Approved

Eisai's Belviq XR (lorcaserin) weight loss medication approved by FDA

July 21, 2016·1 min read
New Rx Says Goodbye to Dry EyesFDA Approvals

New Rx Says Goodbye to Dry Eyes

Shire's Xiidra (lifitegrast ophthalmic solution) approved to treat dry eyes

July 18, 2016·1 min read
A New Treatment for Essential TremorsFDA Approvals

A New Treatment for Essential Tremors

ExAblate Neuro, guided by MRI, approved to treat essential tremors

July 15, 2016·2 min read
First and Only Dronabinol Solution ApprovedFDA Approvals

First and Only Dronabinol Solution Approved

Insys Therapeutics' Syndros (dronabinol) oral solution received FDA approval

July 8, 2016·1 min read
FDA Approves First Absorbable Stent FDA Approvals

FDA Approves First Absorbable Stent

Absorb GT1 BVS, an absorbable stent, approved for coronary artery disease

July 7, 2016·2 min read
New Hepatitis C Rx Approved FDA Approvals

New Hepatitis C Rx Approved

Gilead's Epclusa (sofosbuvir, velpatasvir) approved to treat all major hepatitis C virus forms

June 30, 2016·1 min read
FDA Approves Device for Weight LossFDA Approvals

FDA Approves Device for Weight Loss

AspireAssist obesity device approved as weight management therapy

June 26, 2016·2 min read
Rx for Parathyroid Gland Condition ApprovedFDA Approvals

Rx for Parathyroid Gland Condition Approved

Opko's Rayaldee (calcifediol) approved to treat high parathyroid hormone levels in those with chronic kidney disease

June 22, 2016·1 min read
First Cholera Vaccine ApprovedFDA Approvals

First Cholera Vaccine Approved

Vaxchora approved to prevent cholera by FDA

June 13, 2016·1 min read
First-of-Its-Kind Blood Pressure Rx ApprovedFDA Approvals

First-of-Its-Kind Blood Pressure Rx Approved

Allergan's Byvalson (nebivolol and valsartan) approved to treat high blood pressure

June 11, 2016·1 min read
Prostate Cancer Imaging Just Got a BoostFDA Approvals

Prostate Cancer Imaging Just Got a Boost

Axumin approved to detect recurrent prostate cancer

June 5, 2016·1 min read