Bayer AG, Algeta Win FDA Approval for Prostate Cancer Drug

Thu, 16 May 2013 12:00:00 AM GMT

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Bayer Receives U.S. FDA Approval for Xofigo (radium Ra 223 dichloride) Injection as a New Treatment for Castration-Resistant Prostate Cancer with Bone Metastases

WAYNE, N.J.,

FDA Approves Janssen Biotech Inc.'s Simponi to Treat Ulcerative Colitis

Thu, 16 May 2013 12:00:00 AM GMT

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SIMPONI (golimumab) Receives FDA Approval for Ulcerative Colitis

HORSHAM, Pa., May 15, 2013 /PRNewswire/ -- Janssen Biotech, Inc. announced today that...

FDA Wins New Genentech OK for Lung Cancer Drug, Diagnostic Test

Wed, 15 May 2013 12:00:00 AM GMT

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SOUTH SAN FRANCISCO, Calif. & NORTHBROOK, Ill.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and Astellas Pharma US, Inc. (Astellas), a U.S. subsidiary of Tokyo-based...

Arbor Pharmaceuticals Announces FDA Approval of First NDA

Wed, 15 May 2013 12:00:00 AM GMT

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ATLANTA, May 13, 2013 /PRNewswire/ -- Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration...

FDA Approves GlaxoSmithKline/Theravance, Inc. Drug for COPD Lung Disease

Mon, 13 May 2013 12:00:00 AM GMT

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BREO™ ELLIPTA™ Gains U.S. Approval for the Treatment of COPD

LONDON and SOUTH SAN FRANCISCO, CA--(Marketwired - May 10, 2013) - GlaxoSmithKline...

FDA OKs Novartis AG Drug for a Form of Childhood Arthritis

Mon, 13 May 2013 12:00:00 AM GMT

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Novartis Drug Ilaris® Approved by FDA to Treat Active Systemic Juvenile Idiopathic Arthritis, a Serious Form of Childhood Arthritis

EAST HANOVER, N.J.,

GlaxoSmithKline's BREO™ ELLIPTA™ Receives Regulatory Approval in U.S.

Mon, 13 May 2013 12:00:00 AM GMT

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LONDON, UK, 13 May, 2013 Skyepharma PLC (LSE: SKP), the expert oral and inhalation drug delivery company, announces that the United States Food and Drug Administration (FDA) has approved the New Drug Application...

Curis, Inc. Announces Approval of Erivedge® in Australia

Fri, 10 May 2013 12:00:00 AM GMT

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LEXINGTON, Mass., May 10, 2013 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), an oncology-focused company seeking to develop next generation targeted drug candidates for cancer treatment, today announced that...

Warner Chilcott, PLC Scores FDA Approval for Its New Oral Contraceptive

Thu, 09 May 2013 12:00:00 AM GMT

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DUBLIN, Ireland, May 9, 2013 (GLOBE NEWSWIRE) -- Warner Chilcott plc (WCRX) today announced that the United States Food and Drug Administration (FDA) has approved a new oral contraceptive, norethindrone acetate...

GW Pharmaceuticals Announces Sativex® Commercialization Approval in Italy

Tue, 07 May 2013 12:00:00 AM GMT

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LONDON, May 7, 2013 /PRNewswire/ -- GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, "GW" or the "Company"), a biopharmaceutical company focused on...

FzioMed Inc. Receives Approval for Dynavisc® in Australia

Mon, 06 May 2013 12:00:00 AM GMT

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SAN LUIS OBISPO, Calif.--(BUSINESS WIRE)--FzioMed, a privately held medical device company based in San Luis Obispo, CA., is pleased to announce the inclusion of Dynavisc on the Australian Register of...

Bristol-Myers Squibb Company Says FDA OKs Supplemental NDA for SUSTIVA

Fri, 03 May 2013 12:00:00 AM GMT

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PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for SUSTIVA...

FDA Approves Merck & Co., Inc.'s LIPTRUZET™ (ezetimibe and atorvastatin), a New Product That Can Help Powerfully Lower LDL Cholesterol

Fri, 03 May 2013 12:00:00 AM GMT

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WHITEHOUSE STATION, N.J., May 3, 2013 Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved LIPTRUZET (ezetimibe...

FDA Approves Shire plc's Vyvanse for Children With ADHD

Thu, 02 May 2013 12:00:00 AM GMT

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PHILADELPHIA, PA, USA May 1, 2013 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) approved the prescription...

Raptor Pharmaceutical Inc. Receives FDA Approval for Procysbi

Thu, 02 May 2013 12:00:00 AM GMT

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NOVATO, Calif., April 30, 2013 /PRNewswire/ -- Raptor Pharmaceutical Corp. ("Raptor" or the "Company") (Nasdaq: RPTP), today announced that the U.S. Food and Drug Administration...

Teva Women's Health, Inc.'s Plan B Cleared for Over-the-Counter Sale to Younger Teens

Wed, 01 May 2013 12:00:00 AM GMT

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April 30, 2013 -- The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Womens Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel...

FDA Approves Genentech's ACTEMRA® for Children Living With a Rare Form of Arthritis

Wed, 01 May 2013 12:00:00 AM GMT

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SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved ACTEMRA...

FDA Approves CSL Behring's Kcentra

Wed, 01 May 2013 12:00:00 AM GMT

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KING OF PRUSSIA, Pa., April 30, 2013 /PRNewswire/ -- CSL Behring announced today that the U.S. Food and Drug...

Protalix Biotherapeutics, Inc. Release: UPLYSO™ (alfataliglicerase) Approved in Mexico and Chile for the Treatment of Gaucher Disease

Mon, 29 Apr 2013 12:00:00 AM GMT

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CARMIEL, Israel, April 29, 2013 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE-MKT:PLX) (TASE:PLX), announced today that the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS...

Optimer Pharmaceuticals, Inc.'s DIFICID® Tablets Approved in Australia

Fri, 26 Apr 2013 12:00:00 AM GMT

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JERSEY CITY, N.J., April 26, 2013 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced that the Therapeutic Goods Administration, the Australian...

Becton, Dickinson and Company Unit Receives FDA Approval for Second Simplist Drug

Wed, 24 Apr 2013 12:00:00 AM GMT

FRANKLIN LAKES, N.J., April 23, 2013 /PRNewswire/ -- BD Rx Inc., a wholly-owned subsidiary of leading global medical technology company BD (Becton, Dickinson and Company) (NYSE:BDX), announced today that the U.S. Food and Drug Administration (FDA) has approved the second drug to be offered in the recently launched BD Simplist line of ready-to-administer prefilled...

Warner Chilcott, PLC Announces FDA Approval of New Oral Contraceptive

Tue, 23 Apr 2013 12:00:00 AM GMT

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DUBLIN, Ireland, April 22, 2013 (GLOBE NEWSWIRE) -- Warner Chilcott plc (WCRX) today announced that the United States Food and Drug Administration (FDA) has approved MINASTRINTM 24 FE (norethindrone...

Sucampo Pharmaceuticals, Inc. Wins Approval for Expanded Use of Amitiza in U.S.

Tue, 23 Apr 2013 12:00:00 AM GMT

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BETHESDA, Md. & DEERFIELD, Ill.--(BUSINESS WIRE)-- Sucampo Pharmaceuticals, Inc. (SCMP) (SPI) and Takeda Pharmaceuticals U.S.A., Inc. (TPUSA) announced today that the United States (U.S.) Food and Drug Administration...

Roche Release: Health Canada Approves PERJETA™, a New First-In-Class Targeted Therapy for the Treatment of HER2-Positive Metastatic Breast Cancer(1)

Tue, 23 Apr 2013 12:00:00 AM GMT

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MISSISSAUGA, ON, April 23, 2013 /CNW/ - While awareness and support for breast cancer research is at an all-time high and Canadians "think pink," one-quarter of Canadian women are still not convinced a breast...

European Commission (EC) Gives Green Light to New 6-in-1 Childhood Vaccine From Sanofi Pasteur

Tue, 23 Apr 2013 12:00:00 AM GMT

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Lyon, France - April 22, 2013 - Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that the European Commission approved Sanofi Pasteurs 6-in-1 pediatric vaccine...

FDA Approves Novartis AG's Simbrinza for Glaucoma

Mon, 22 Apr 2013 12:00:00 AM GMT

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Alcon, the global leader in eye care and a division of Novartis, has received US Food and Drug Administration (FDA) approval for Simbrinza suspension, indicated for the reduction of elevated intraocular...

Purdue Pharma L.P. Statement on FDA Approval of New Label for Reformulated Oxycontin® (Oxycodone HCL Controlled-Release) Tablets CII and Citizen Petition Regarding Withdrawal of Original Formulation Due to Safety

Thu, 18 Apr 2013 12:00:00 AM GMT

April 16, 2013 STAMFORD, Conn. Purdue Pharma L.P. today announced that the U.S. Food and Drug Administration (FDA) has approved new language for the product label for OxyContin (oxycodone hydrochloride controlled-release) Tablets CII that describes abuse-deterrence studies conducted with the reformulated tablets. Additionally, Purdue is gratified that the FDA has determined that OxyContin extended...

Sinovac Biotech Ltd. Receives Commercial Approval in Mexico for Seasonal Flu Vaccine

Thu, 18 Apr 2013 12:00:00 AM GMT

BEIJING, April 18, 2013 /PRNewswire/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of vaccines in China, announced today that it has received the Certificate of Approval to commercialize seasonal flu vaccine in Mexico by the Federal...

Sun Pharmaceutical Industries Ltd Gets FDA Nod for Generic Version of Januvia

Tue, 16 Apr 2013 12:00:00 AM GMT

Domestic generic major Sun Pharma's "tentative'' approval to launch generic diabetes drug Januvia in the US market has raised eyebrows, providing a twist to the patent challenge being fought between the innovator Merck and Glenmark in the country. Sun Pharma, which is a co-partner of Merck's subsidiary for marketing Januvia in the country, received approval to launch generic Januvia (sitagliptin) in...

BioAlliance Pharma's Sitavig® Receives Market Authorization in the U.S. for the Treatment of Herpes Labialis

Tue, 16 Apr 2013 12:00:00 AM GMT

PARIS--(BUSINESS WIRE)--Regulatory News: BioAlliance Pharma SA (Paris:BIO), today announced the receipt of marketing authorization from the U.S. Food and Drug Administration (FDA) for Sitavig in the treatment of recurring Herpes labialis, marking the successful conclusion to the assessment procedure carried out by the American authorities. After Loramyc , registered in 26 countries including the...

CSL Behring Receives European Health Authorities' Approval of Berinert® for Short-Term Prophylaxis in Adults and Children

Tue, 16 Apr 2013 12:00:00 AM GMT

MARBURG, Germany, April 16, 2013 /PRNewswire/ -- CSL Behring today announced that European health authorities have approved an extended use of Berinert, a C1-esterase inhibitor (C1-INH) concentrate, for pre-procedure prevention (short-term prophylaxis...

Taro Pharmaceutical Industries Ltd. Gets FDA Approval for Topicort Topical Spray

Mon, 15 Apr 2013 12:00:00 AM GMT

HAWTHORNE, N.Y.--(BUSINESS WIRE)-- Taro Pharmaceutical Industries Ltd. (TARO) (Taro) reported today that it has received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) Topicort (desoximetasone) Topical Spray, 0.25%.

Topicort (desoximetasone) Topical Spray, 0.25% is a corticosteroid indicated for the treatment of plaque psoriasis in patients...

Warner Chilcott, PLC Receives FDA Approval of DORYX Delayed-Release 200 Mg Tablets

Fri, 12 Apr 2013 12:00:00 AM GMT

DUBLIN, Ireland, April 12, 2013 (GLOBE NEWSWIRE) -- Warner Chilcott plc (WCRX) today announced that the United States Food and Drug Administration (FDA) has approved a 200 mg strength of DORYX(R) (doxycycline hyclate) Delayed-Release Tablets. DORYX Delayed-Release Tablets are a tetracycline-class oral antibiotic. The Company anticipates that it will commercially launch DORYX Delayed-Release 200 mg...

FDA Approves Diclegis for Morning Sickness

Tue, 09 Apr 2013 12:00:00 AM GMT

ROSEMONT, Pa., April 8, 2013 /PRNewswire/ -- Duchesnay USA today announced that the Food and Drug Administration (FDA) has granted approval for Diclegis (doxylamine succinate 10mg, pyridoxine hydrochloride 10mg) delayed-release tablets for the treatment of nausea and vomiting of pregnancy (NVP) in women who do...

Bausch & Lomb Receives FDA Approval for PROLENSA™

Tue, 09 Apr 2013 12:00:00 AM GMT

MADISON, N.J., April 8, 2013 /PRNewswire/ -- Bausch Lomb, the global eye health company, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for PROLENSA (bromfenac ophthalmic solution) 0.07 percentprescription eye drop, an innovative once-daily nonsteroidal anti-inflammatory...

Biogen Idec Canada Release: Health Canada Approves TECFIDERA™ as a First-Line Oral Treatment for Multiple Sclerosis

Tue, 09 Apr 2013 12:00:00 AM GMT

MISSISSAUGA, ON, April 9, 2013 /CNW/ - Today, Biogen Idec Canada announced the Health Canada approval of TECFIDERA (dimethyl fumarate) delayed-release capsules, formerly BG-12, as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). TECFIDERA is indicated as monotherapy for the treatment of RRMS to reduce the frequency of clinical exacerbations and to delay the...

FDA Approves Johnson & Johnson's New Diabetes Drug

Mon, 08 Apr 2013 12:00:00 AM GMT

RARITAN, N.J., March 29, 2013 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration (FDA) has approved INVOKANA (canagliflozin) for the treatment of adults with type 2 diabetes. INVOKANA is the first in a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors to be approved in

Genzyme Corporation's AUBAGIO® Approved in Argentina for MS

Mon, 08 Apr 2013 12:00:00 AM GMT

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today Argentinas National Administration of Drugs, Food and Medical Technology (ANMAT) has approved once-daily, oral AUBAGIO 14 mg as a new treatment indicated for patients with relapsing forms of multiple sclerosis (MS).

Studied in one of the largest clinical trial programs of any MS...

FDA Approves Tris Pharma, Inc.'s Karbinal™ ER

Wed, 03 Apr 2013 12:00:00 AM GMT

MONMOUTH JUNCTION, N.J., April 3, 2013 /PRNewswire/ -- Tris Pharma, a specialty pharmaceutical company focused on developing innovative drug delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg...

Health Canada Approves Next Pharmaceuticals' Relora®

Tue, 02 Apr 2013 12:00:00 AM GMT

SALINAS, CA--(Marketwire - April 01, 2013) - Health Canada has issued NPN 505349 for Relora, enabling the all-natural dietary supplement to be sold throughout Canada. Health Canada is the country's Federal department responsible for "helping Canadians maintain and improve their health" and rewarding these product licenses, required by all natural health products sold in Canada. Health Canada's review...

Teva Pharmaceutical Industries Limited Wins FDA Approval for Oral Contraceptive

Tue, 02 Apr 2013 12:00:00 AM GMT

JERUSALEM--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets for the prevention of pregnancy. Quartette represents the next generation of extended regimen oral contraceptives to be approved by the FDA, and was designed to minimize breakthrough...

Health Canada Approves NEUPRO® Patch for Treatment of Parkinson's Disease

Tue, 02 Apr 2013 12:00:00 AM GMT

OAKVILLE, ON, April 2, 2013 /CNW/ - UCB Canada Inc. announced today that Health Canada has approved NEUPRO (rotigotine), the first and only non-ergolinic dopamine agonist available in a patch, to treat the signs and symptoms of idiopathic Parkinson's disease (PD) and moderate-to-severe idiopathic restless legs syndrome (RLS), also known as Willis-Ekbom disease, in adults.

NEUPRO is the...

Astellas Pharma Inc.'s Acofide Approved in Japan

Fri, 29 Mar 2013 12:00:00 AM GMT

Astellas Pharma, Inc. and Zeria Pharmaceutical Co., Ltd. recently announced that it received approval from Japans Ministry of Health, Labour and Welfare (MHLW) for Acofide for the treatment of functional dyspepsia (FD). The regulatory application was based on a multicenter, randomized, double-blind, parallel-group and placebo-controlled phase III clinical study. The results showed statistically significant...

Biogen Idec, Inc. (Massachusetts) Wins FDA Approval for Blockbuster Oral MS Drug

Thu, 28 Mar 2013 12:00:00 AM GMT

WESTON, Mass.--(BUSINESS WIRE)-- Today Biogen Idec (BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TECFIDERA (dimethyl fumarate), a new first-line oral treatment for people with relapsing forms of multiple sclerosis (MS). Biogen Idec will make this oral capsule available to people living with MS in the United States in the coming days.

TECFIDERA has been clinically...

Eisai Inc. Announces FDA Approval for Aciphex Sprinkle

Thu, 28 Mar 2013 12:00:00 AM GMT

WOODCLIFF LAKE, N.J., March 26, 2013 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved ACIPHEX Sprinkle Delayed-Release Capsules 5mg and 10mg for the treatment of Gastroesophageal Reflux Disease (GERD) in children 1 to 11 years of age for up to 12 weeks.

"We are proud to offer a new treatment...

Bayer AG's Colorectal Cancer Drug Stivarga Bags Approval in Japan

Tue, 26 Mar 2013 12:00:00 AM GMT

WAYNE, N.J. and SOUTH SAN FRANCISCO, Calif., March 25, 2013 /PRNewswire/ -- Bayer HealthCare and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) announced today that the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved Stivarga (regorafenib) tablets for the treatment of patients...

Novartis AG' TOBI Podhaler Gets FDA Approval