Advertisement
Approvals
Subscribe to Approvals

The Lead

FDA Approves EYLEA Injection for the Treatment of Diabetic Macular Edema

July 30, 2014 8:03 am | News | Comments

Regeneron Pharmaceuticals announced that the FDA has approved EYLEA Injection for the treatment of Diabetic Macular Edema (DME). The recommended dosage of EYLEA in patients with DME is 2 milligrams every two months after five initial monthly injections.

European Commission Approves Eliquis for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism

July 29, 2014 8:38 am | News | Comments

Bristol-Myers Squibb and Pfizer announced that the European Commission has approved Eliquis for...

FDA Grants Full Approval for IMBRUVICA for Two Indications

July 28, 2014 2:39 pm | News | Comments

Pharmacyclics, Inc. announced that the FDA has granted IMBRUVICA regular (full) approval for the...

FDA Approves Aqua Pharmaceuticals' ACTICLATE™ Tablets

July 28, 2014 9:11 am | News | Comments

ACTICLATE™ is a tetracycline-class antibacterial indicated for the treatment of a number of...

View Sample

FREE Email Newsletter

FDA Approves New Extended-Release Oxycodone with Abuse-Deterrent Properties

July 24, 2014 7:59 am | News | Comments

The FDA has approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

FDA Approves Gilead Sciences Drug for Three Cancers

July 23, 2014 1:07 pm | News | Comments

Regulators approved the drug for patients with forms of chronic lymphocytic leukemia, follicular lymphoma and small lymphocytic lymphoma. The cancers affect an estimated 200,000 patients in the U.S., according to Gilead. The company's tablet, Zydelig, works by blocking signals inside some cancer cells that allow them to grow and survive.

FDA Approves Eagle Pharmaceuticals’ Ryanodex®

July 23, 2014 8:09 am | News | Comments

Eagle Pharmaceuticals today announced that the FDA has approved Ryanodex® (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures.    

Advertisement

FDA Approves New Product to Treat Rare Genetic Disease

July 17, 2014 10:22 am | News | Comments

The FDA has approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).           

FDA Approves Purdue Pharma’s 7.5 mcg/hour Dosage Strength of Butrans

July 16, 2014 8:31 am | News | Comments

Purdue Pharma announced that the FDA has approved a new 7.5 mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII. Five strengths of Butrans will now be available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour and 20 mcg/hour.

FDA Grants Roche’s Avastin Priority Review for Certain Types of Cervical Cancer

July 15, 2014 8:38 am | News | Comments

Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer.

FDA Approves First Drug from Anacor Pharma

July 8, 2014 1:38 pm | News | Comments

Shares of Anacor Pharmaceuticals Inc. climbed Tuesday morning after federal regulators approved its first drug, the toenail fungus treatment Kerydin, a few weeks ahead of schedule.            

Japan Approves First All-Oral, Interferon- and Ribavirin-Free Hepatitis C Treatment, Daklinza® and Sunvepra® Dual Regimen

July 7, 2014 8:19 am | News | Comments

Bristol-Myers Squibb Company has announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Daklinza® (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor ( in vitro ), and Sunvepra® (asunaprevir), a NS3/4A protease inhibitor, providing a new treatment that can lead to cure for many patients in Japan who currently have no treatment options.

Advertisement

FDA Grants Spectrum Pharmaceuticals Accelerated Approval of Beleodaq™ for Injection

July 7, 2014 8:15 am | News | Comments

Spectrum Pharmaceuticals, with a primary focus in Hematology and Oncology, announced that the FDA has granted Accelerated Approval of Beleodaq™ for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).  

It's All In The Delivery

June 30, 2014 11:45 am | by Mike Auerbach, Editor in Chief | Blogs | Comments

There are times when you hold new technology in your hands and realize that you are looking at something special, something that will, to use an oft-cited cliché, be a “game-changer.”           

FDA Approves Updated Labeling for Gattex® for Injection to Include Long-Term Data

June 30, 2014 8:45 am | News | Comments

NPS Pharmaceuticals today announced that the FDA has approved updated labeling for Gattex® (teduglutide [rDNA origin]) for injection to include long-term data from the STEPS 2 study of adult patients with Short Bowel Syndrome (SBS).   

Flamel Technologies Announces FDA Approval of VAZCULEP

June 30, 2014 8:05 am | News | Comments

VAZCULEP Injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.           

FDA Approves Inhalable Diabetes Drug Afrezza

June 27, 2014 6:26 pm | by The Associated Press | News | Comments

The Food and Drug Administration on Friday approved a long-delayed inhalable diabetes medication to help patients control their blood sugar levels during meals. The FDA cleared MannKind Corp.'s Afrezza, a fast-acting form of insulin, for adults with the most common form of diabetes, which affects more than 25 million Americans.

Advertisement

EYLEA Injection Recommended for Approval for the Treatment of Visual Impairment due to Diabetic Macular Edema in the EU

June 27, 2014 8:33 am | News | Comments

Regeneron Pharmaceuticals today announced that EYLEA (aflibercept) Injection has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of visual impairment due to diabetic macular edema (DME).

Vertex Receives European CHMP Positive Opinion for KALYDECO in Eight Non-G551D Gating Mutations

June 27, 2014 8:24 am | News | Comments

Vertex Pharmaceutical today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of KALYDECO™ (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

CHMP Recommends Lilly and Boehringer Ingelheim's New Insulin Glargine Product for Approval in the European Union

June 27, 2014 8:20 am | News | Comments

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval for the investigational compound LY2963016, a new insulin glargine product, for the treatment of type 1 and type 2 diabetes.   

FDA Clears Robotic Legs for Some Paralyzed People

June 27, 2014 8:14 am | News | Comments

Federal health regulators have approved a first-of-a-kind set of robotic leg braces that can help some disabled people walk again. The ReWalk system functions like an exoskeleton for people paralyzed from the waist down, allowing them to stand and walk with assistance from a caretaker.

Boehringer Ingelheim's Investigational Antidote for Pradaxa Receives FDA Breakthrough Therapy Designation

June 26, 2014 8:25 am | News | Comments

Boehringer Ingelheim announced that FDA has granted Breakthrough Therapy Designation to idarucizumab, an investigational fully humanized antibody fragment, or Fab, being studied as a specific antidote for Pradaxa (dabigatran etexilate mesylate).

USDA Gives Initial Approval to Pig Virus Vaccine

June 26, 2014 8:19 am | by M.L. JOHNSON, Associated Press | News | Comments

The federal government has given conditional approval to the first vaccine licensed to fight a deadly pig virus, and warmer weather appears to be slowing the spread of the disease that has been blamed in part for making bacon more expensive. 

FDA Approves Cubist Antibiotic for Skin Infections

June 23, 2014 8:14 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

The Food and Drug Administration on Friday approved a new antibiotic from Cubist Pharmaceuticals to treat common skin infections often acquired in the hospital. Regulators cleared the company's Sivextro as a pill and as an intravenous solution for adults with skin infections caused by bacteria that are often resistant to older antibiotics.

Medtronic Heart Valve Approved for Broader Use

June 13, 2014 8:10 am | News | Comments

Medtronic announced that the FDA approved its artificial heart valve, CoreValve, for use in more patients who face serious risks from open-heart surgery, the standard treatment. Medtronic's implant is a less invasive approach to replacing diseased aortic heart valves, which can often lead to heart failure, blood clots and sudden death.

FDA Approves Bayer's Gadavist as Magnetic Resonance Contrast Agent for Breast Cancer

June 12, 2014 9:18 am | News | Comments

Bayer HealthCare announced today that the FDA has approved a new indication for Gadavist  (gadobutrol) injection for intravenous use with MRI of the breast to assess the presence and extent of malignant breast disease.     

FDA Approves the First Antihemophilic Factor, Fc Fusion Protein for Patients with Hemophilia A

June 9, 2014 8:11 am | News | Comments

The U.S. Food and Drug Administration has approved Eloctate, Antihemophilic Factor (Recombinant), Fc fusion protein, for use in adults and children who have Hemophilia A. Eloctate is the first Hemophilia A treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.

FDA Oks Valeant Toenail Fungus Treatment Jublia

June 9, 2014 7:26 am | by The Associated Press | News | Comments

The Food and Drug Administration has approved a toenail fungus treatment from Valeant Pharmaceuticals International Inc. that could reach $800 million in peak U.S. sales, according to the Canadian drugmaker.        

FDA Approves First Generic Versions of Celecoxib

May 30, 2014 4:10 pm | News | Comments

The FDA today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.           

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading