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FDA Approves New Sleeping Drug from Merck

August 13, 2014 4:29 pm | by The Associated Press | News | Comments

Merck & Co. has won federal approval for a new type of sleeping pill designed to help people with insomnia stay asleep. The tablet, Belsomra, works by temporarily blocking chemicals known as orexins that control the sleep cycle and can keep people awake at night.

FDA Approves Lung Preservation Machine

August 13, 2014 8:13 am | News | Comments

The Food and Drug Administration said Tuesday that the approval of the XVIVO Perfusion System...

FDA Approves DNA-Based Test for Colon Cancer

August 12, 2014 8:33 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

The Cologuard test from Exact Sciences detects irregular mutations in stool samples that can be...

FDA Approves INVOKAMET for the Treatment of Adults with Type 2 Diabetes

August 11, 2014 8:26 am | News | Comments

INVOKAMETT provides the clinical attributes of INVOKANA (canagliflozin), the first sodium...

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FDA Approves VELCADE® Retreatment in Patients with Multiple Myeloma

August 11, 2014 8:19 am | News | Comments

Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited, has announced that the FDA has approved VELCADE® for the retreatment of adult patients with multiple myeloma who had previously responded to VELCADE therapy and relapsed at least six months following completion of prior VELCADE treatment.

EU Approves EYLEA Injection for Diabetic Macular Edema

August 11, 2014 8:12 am | News | Comments

Regeneron Pharmaceuticals today announced that EYLEA (aflibercept) Injection has been approved by the European Commission for the treatment of visual impairment due to Diabetic Macular Edema (DME). Bayer Healthcare plans to launch EYLEA in DME in the EU this quarter.

FDA Approves ORBACTIV™ for Acute Bacterial Skin and Skin Structure Infections

August 7, 2014 8:43 am | News | Comments

The Medicines Company today announced that the FDA has approved ORBACTIV™ (oritavancin) for injection for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA).

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European Commission Approves Octapharma’s Nuwiq® for Hemophilia A

August 6, 2014 8:44 am | News | Comments

The European Commission has published approval of Octapharma’s Nuwiq ® (simoctocog alfa) for the treatment and prophylaxis of bleeding in all age groups with hemophilia A (congenital factor VIII [FVIII] deficiency). Nuwiq ® is the newest generation of FVIII replacement, produced in a human cell line cultured without additives of human or animal origin.

FDA Approves Lannett's Oxycodone Hydrochloride Capsules 5 mg

August 4, 2014 8:59 am | News | Comments

Lannett Company today announced that it has received approval from the FDA of its Abbreviated New Drug Application (ANDA) for Oxycodone Hydrochloride Capsules, 5 mg, the therapeutic equivalent to the reference listed drug, Oxycodone Hydrochloride Capsules, 5 mg, of Lehigh Valley Technologies.

Genzyme Receives Label Expansion for Lumizyme® in the U.S. for the Treatment of Pompe Disease

August 4, 2014 8:40 am | News | Comments

Genzyme, a Sanofi company announced that the FDA approved a supplement to expand the indication for Lumizyme ® (alglucosidase alfa). Lumizyme manufactured at the 4000L scale is now indicated for all Pompe patients of any age or phenotype.  

FDA Approves Lilly, Boehringer Diabetes Drug

August 1, 2014 1:34 pm | by The Associated Press | News | Comments

Federal regulators have approved a new treatment from U.S. drugmaker Eli Lilly and Co. and its German counterpart, Boehringer Ingelheim, for the most common form of diabetes . The Food and Drug Administration said Friday it will permit Jardiance tablets to be used by adult patients with type 2 diabetes.

Hovione’s Cork, Ireland API Plant Passes FDA Pre- Approval Inspection

July 31, 2014 1:26 pm | News | Comments

The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued.              

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Israel's Ministry of Health Approves Pluristem's Commercial-Scale 3D Cell Manufacturing Process

July 31, 2014 10:58 am | News | Comments

Pluristem Therapeutics has announced that it has completed the approval process and received final clearance from a fifth regulatory agency for its 3D cell therapy manufacturing processes in use at its new facility in Haifa.     

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 the treatment of DVT and PE, and the prevention of recurrent DVT and PE in adults. The European Commission approval applies to all European Union (EU) member states as well as Iceland and Norway.

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 treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17 (del 17p CLL), including treatment naive and previously treated del 17p CLL patients.

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 infections, including adjunctive therapy in severe acne.                 

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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.    

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.

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.           

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