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FDA Approves Merck’s Allergy Treatment

April 15, 2014 8:04 am | News | Comments

Merck has announced that FDA has approved GRASTEK ® (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use [2800 Bioequivalent Allergy Units (BAU)]. GRASTEK is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis.

Oramed Granted Patent in Hong Kong for Oral Administration of Insulin

April 10, 2014 8:16 am | News | Comments

Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development...

FDA Approves Handheld Opiate Antidote

April 4, 2014 8:53 am | Videos | Comments

One person dies every 36 minutes from an opioid overdose from painkillers. A recently approved...

FDA Approves EVZIO for the Emergency Treatment of Opioid Overdose

April 3, 2014 11:01 am | News | Comments

Kaleo announced that the FDA has approved EVZIO (naloxone hydrochloride injection) for the...

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FDA OKs First Hay Fever Allergy Immunotherapy Tablet

April 2, 2014 11:28 am | by The Associated Press | News | Comments

The U.S. Food and Drug Administration has approved the first tablet for gradually reducing hay fever allergy symptoms, an alternative to uncomfortable allergy-desensitizing shots.            

FDA Approves Topamax for Migraine Prevention in Adolescents

March 31, 2014 8:42 am | News | Comments

The FDA has approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group.       

FDA Approves Biogen Idec’s ALPROLIX™

March 31, 2014 8:21 am | News | Comments

Biogen Idec has announced that the FDA has approved ALPROLIX™ [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the first recombinant, DNA derived hemophilia B therapy with prolonged circulation in the body.      

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XTANDI Capsules Approved in Japan for Prostate Cancer

March 25, 2014 7:20 am | News | Comments

Astellas Pharma Inc. has obtained marketing approval of their oral androgen receptor signaling inhibitor, XTANDI capsules 40mg  for the treatment of patients with castration-resistant prostate cancer in Japan.      

Japan Approves Forxiga® for Type 2 Diabetes

March 24, 2014 9:00 am | News | Comments

AstraZeneca today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved FORXIGA® (dapagliflozin in 5 and 10 mg tablets), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, as a once-daily oral treatment for type 2 diabetes.

FDA Approves Xolair for Chronic Idiopathic Urticaria

March 24, 2014 8:25 am | News | Comments

The FDA has approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives. The new use is for patients 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy.

Samsca® Approved in Japan as World's First Drug Therapy for ADPKD, a Rare Kidney Disease

March 24, 2014 8:05 am | News | Comments

Otsuka Pharmaceutical Co. has become the first company in the world to obtain regulatory approval for a pharmacological treatment of autosomal dominant polycystic kidney disease (ADPKD).           

Health Canada Approves ALPROLIX™ Therapy for Hemophilia B

March 21, 2014 8:24 am | News | Comments

Biogen Idec announced that Health Canada has approved ALPROLIX ™, for the control and prevention of bleeding episodes and routine prophylaxis in adults, and children aged 12 and older, with hemophilia B.        

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FDA Approves Eliquis® to Reduce The Risk Of Blood Clots Following Hip Or Knee Replacement Surgery

March 17, 2014 8:12 am | News | Comments

Bristol-Myers Squibb Company and Pfizer announced that the FDA approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

NOXAFIL® Injection Approved for Intravenous Use

March 14, 2014 1:54 pm | News | Comments

Merck has announced that the U.S. Food and Drug Administration has approved NOXAFIL® (posaconazole) injection (18 mg/ mL), a new formulation of NOXAFIL for intravenous (IV) use. Merck’s antifungal agent is also marketed as NOXAFIL (100 mg) delayed-release tablets and NOXAFIL (40 mg/mL) oral suspension.

FDA Committee Recommends Roche's HPV Test for Detection of Cervical Cancer

March 13, 2014 8:27 am | News | Comments

Roche has announced FDA Microbiology Devices Panel of the Medical Devices Advisory Committee recommended unanimously that the benefits of the cobas HPV (Human Papillomavirus) Test as a first-line primary screening tool in women 25 years and older to assess their risk of cervical cancer based on the presence of clinically relevant high-risk HPV DNA outweigh the risks.

FDA Approves Qudexy XR Extended-Release Capsules

March 12, 2014 11:53 am | News | Comments

Upsher-Smith Laboratories, Inc. has received approval from the FDA for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic (PK) profile.  

XARTEMIS XR Approval Triggers $10M Milestone Payment

March 12, 2014 10:56 am | News | Comments

Depomed today announced that the FDA approved Mallinckrodt plc's New Drug Application (NDA) for XARTEMIST XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), previously known as MNK-795.      

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Electric Headband Approved to Prevent Migraines

March 12, 2014 8:12 am | News | Comments

The FDA has approved a nerve-stimulating headband as the first medical device to prevent migraine headaches. Agency officials said the device provides a new option for patients who cannot tolerate migraine medications.     

Pluristem's Commercial Scale Cell Manufacturing Process Approved by FDA

March 6, 2014 10:06 am | News | Comments

Pluristem Therapeutics today announced that the FDA has reviewed its PLacental eXpanded (PLX) cell products and granted approval for the company to manufacture them in its new commercial-scale cell manufacturing facility.        

FDA Approves Endo U.S. Testosterone Replacement Therapy

March 6, 2014 8:13 am | News | Comments

Endo Pharmaceuticals has received FDA approval of AVEED (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone.

Generic Evista® Tablets 60 mg Approved in the United States

March 4, 2014 9:42 am | News | Comments

Teva Pharmaceutical has announced the approval of the generic equivalent to Evista® (Raloxifene) Tablets, 60 mg, in the United States. Teva was first to file, making the product eligible for 180 days of marketing exclusivity.    

Bydureon Pen Approved for Type 2 Diabetes

March 3, 2014 8:33 am | News | Comments

AstraZeneca has announced that the FDA has approved the BYDUREON® Pen (exenatide extended-release for injectable suspension) 2 mg as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.    

FDA Approves Myalept to Treat Rare Metabolic Disease

February 25, 2014 9:09 am | News | Comments

The FDA has approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy.    

Iroko Pharmaceuticals Receives FDA Approval for TIVORBEX™

February 25, 2014 8:31 am | News | Comments

Iroko Pharmaceuticals, LLC, has announced that the FDA has approved TIVORBEX™ (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20 mg and 40 mg doses for the treatment of mild to moderate acute pain in adults.   

FDA Approves KALYDECO for Use in Eight Additional Mutations that Cause Cystic Fibrosis

February 21, 2014 3:08 pm | News | Comments

Vertex Pharmaceuticals today announced the FDA approved a supplemental New Drug Application (sNDA) for KALYDECO (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have one of eight additional mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

FDA Approves Northera to Treat Neurogenic Orthostatic Hypotension

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

The FDA has approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure. 

Shire Announces FDA Approval of VPRIV Manufacturing Facility

February 14, 2014 10:39 am | News | Comments

Shire has announced that the FDA has approved the production of VPRIV drug substance (velaglucerase alfa for injection) in Shire's manufacturing facility in Lexington, Massachusetts. The facility was previously approved by the European Medicines Agency (EMA) for production of VPRIV drug substance.

FDA Approves Imbruvica to Treat Chronic Lymphocytic Leukemia

February 12, 2014 1:18 pm | News | Comments

The FDA has expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.               

Genzyme’s Lemtrada® Approved in Mexico for Treatment of Multiple Sclerosis

February 4, 2014 8:18 am | News | Comments

Genzyme has announced that Mexico’s national regulatory authority, COFEPRIS, has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing remitting forms of multiple sclerosis (MS) to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations.

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