FDA Approvals News

Latest fda approvals news, reviewed by pharmacists.

FDA Approvals articles

New Medical Device Treats Urinary Symptoms Related to Enlarged ProstateFDA Approvals

New Medical Device Treats Urinary Symptoms Related to Enlarged Prostate

UroLift system approved to treat men with enlarged prostate

September 13, 2013·2 min read
Nexavar Gets FDA Nod for Thyroid CancerFDA Approvals

Nexavar Gets FDA Nod for Thyroid Cancer

Sorafenib granted FDA Priority Review designation for supplemental NDA

September 3, 2013·2 min read
FDA Approves First Genotyping Test for Patients with Hepatitis C VirusFDA Approvals

FDA Approves First Genotyping Test for Patients with Hepatitis C Virus

Abbott RealTime HCV Genotype II approved to identify genotype of hepatitis C virus in patients

June 20, 2013·2 min read
FDA Approves new Silicone Gel-filled Breast ImplantFDA Approvals

FDA Approves new Silicone Gel-filled Breast Implant

MemoryShape Breast Implant approved for use in women at least 22 years old

June 14, 2013·3 min read
New Influenza Vaccine from Sanofi Pasteur Now Licensed by FDAFDA Approvals

New Influenza Vaccine from Sanofi Pasteur Now Licensed by FDA

Fluzone Quadrivalent vaccine approved to treat influenza in children and adults

June 11, 2013·3 min read
FDA Approves Two Drugs, Companion Diagnostic Test for Advanced Skin CancerFDA Approvals

FDA Approves Two Drugs, Companion Diagnostic Test for Advanced Skin Cancer

Two melanoma medications and companion diagnostic approved for patients

May 29, 2013·3 min read
Intercell Announces Pediatric Approval of its Japanese Encephalitis Vaccine in the USFDA Approvals

Intercell Announces Pediatric Approval of its Japanese Encephalitis Vaccine in the US

Ixiaro vaccine approved for children to protect against Japanese encephalitis

May 21, 2013·2 min read
Novartis Rx Ilaris Approved by FDAFDA Approvals

Novartis Rx Ilaris Approved by FDA

Ilaris approved to treat patients with active systemic juvenile idiopathic arthritis

May 10, 2013·2 min read
FDA Approves Invokana to Treat Type 2 DiabetesFDA Approvals

FDA Approves Invokana to Treat Type 2 Diabetes

Invokana approved to improve glycemic control in adults with type 2 diabetes

March 29, 2013·2 min read
FDA Approves new Multiple Sclerosis TreatmentFDA Approvals

FDA Approves new Multiple Sclerosis Treatment

Tecfidera capsules approved to treat adults with relapsing forms of MS

March 27, 2013·2 min read
FDA Approves First Botulism AntitoxinFDA Approvals

FDA Approves First Botulism Antitoxin

Botulism Antitoxin approved for use in neutralizing all known botulinum nerve toxin serotypes

March 25, 2013·2 min read
FDA Approves TOBI Podhaler FDA Approvals

FDA Approves TOBI Podhaler

TOBI Podhaler treats bacterial lung infection in cystic fibrosis patients

March 23, 2013·2 min read
FDA Approves Dotarem, a New Magnetic Resonance Imaging AgentFDA Approvals

FDA Approves Dotarem, a New Magnetic Resonance Imaging Agent

Dotarem safer and more effective in finding CNS abnormalities in patients

March 20, 2013·2 min read
FDA Approves Lymphoseek to Help Locate Lymph NodesFDA Approvals

FDA Approves Lymphoseek to Help Locate Lymph Nodes

Lymphoseek imaging drug will help find lymph nodes in certain cancer patients

March 13, 2013·2 min read
FDA Approves Osphena for Postmenopausal Women Experiencing Pain During SexFDA Approvals

FDA Approves Osphena for Postmenopausal Women Experiencing Pain During Sex

Osphena approved to treat severe pain during sexual intercourse for womem

February 26, 2013·2 min read
FDA Approves New GIST Rx FDA Approvals

FDA Approves New GIST Rx

Stivarga receives FDA approval to treat GIST

February 25, 2013·2 min read
FDA Approves Stivarga for Advanced Gastrointestinal Stromal TumorsFDA Approvals

FDA Approves Stivarga for Advanced Gastrointestinal Stromal Tumors

Stivarga blocks several enzymes that promote cancer growth

February 25, 2013·3 min read
FDA Approves New Treatment for Late-Stage Breast CancerFDA Approvals

FDA Approves New Treatment for Late-Stage Breast Cancer

FDA has approved Kadcyla to help treat breast cancer

February 22, 2013·3 min read
FDA Approves new Silicone Gel-Filled Breast ImplantFDA Approvals

FDA Approves new Silicone Gel-Filled Breast Implant

Agency requires post approval safety studies to assess rare events

February 21, 2013·3 min read
FDA Approves First Retinal Implant for Adults with Rare Genetic Eye DiseaseFDA Approvals

FDA Approves First Retinal Implant for Adults with Rare Genetic Eye Disease

Argus II Retinal Prosthesis System approved to treat retinitis pigmentosa

February 14, 2013·4 min read
FDA Approves Pomalyst for Advanced Multiple MyelomaFDA Approvals

FDA Approves Pomalyst for Advanced Multiple Myeloma

Certified prescribers can now use Pomalyst to help treat multiple myeloma

February 11, 2013·3 min read
FDA Approval of Generic Doxil is Expected to Help Resolve ShortageFDA Approvals

FDA Approval of Generic Doxil is Expected to Help Resolve Shortage

Doxil injection is currently on the FDA drug shortage list

February 4, 2013·2 min read
FDA Approves Three New Drug Treatments for Type 2 DiabetesFDA Approvals

FDA Approves Three New Drug Treatments for Type 2 Diabetes

Three new drugs are approved to improve sugar control in adults with type 2 diabetes

January 29, 2013·3 min read
FDA Approves Gleevec for Children With Acute Lymphoblastic LeukemiaFDA Approvals

FDA Approves Gleevec for Children With Acute Lymphoblastic Leukemia

Gleevec blocks proteins that promote cancer development

January 25, 2013·2 min read