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About 1131 results for "us fda"

ACADIA: FDA Grants Breakthrough Therapy Status To NUPLAZID

ACADIA Pharmaceuticals Inc. (ACAD: Quote), a biopharmaceutical company, Tuesday said the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to NUPLAZID (pimavanserin) for the treatment of Parkinson's disease psychosis. ... RTTNews.com, 1 hour ago
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282 images for us fda

Bio Spectrum Asia, 4 days ago
Med India, 1 week ago
CNN, 23 hours ago
Asiaone, 2 weeks ago
Pharma Letter, 2 weeks ago
ABC News 4 Charleston, 1 day ago
Sys-Con Media, 1 day ago
KSWT13, 1 day ago
Business Standard, 1 day ago
Bio Spectrum Asia, 3 weeks ago

FDA Grants Orphan Drug Status To Arena's PAH Drug APD811

Arena Pharmaceuticals, Inc. (ARNA: Quote), developer of the weight management drug Belviq, Tuesday said its pulmonary arterial hypertension drug, APD811, was granted orphan drug status by the US Food and Drug Administration. "We are pleased with ...
 RTTNews.com2 hours ago Promedior Receives U.S. Orphan Drug Designation for PRM-151 for the Treatment of Myelofibrosis  Morningstar.com2 hours ago
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PR Newswire

Actavis Announces FDA Acceptance for Filing of NDA for Eluxadoline

DUBLIN , Sept. 2, 2014 /PRNewswire/ -- Actavis plc ( NYSE: ACT ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' New Drug Application (NDA) for eluxadoline, an investigational drug for the treatment ...
 Tamar Securities1 hour ago BRIEF-Ipsen says FDA grants priority review for somatuline depot 120mg injection  Reuters1 day ago FDA Grants Amgen Priority Review Designation For Ivabradine For The Treatment Of Chronic Heart Failure  Drugs.com15 hours ago Ipsen Announces Acceptance of Filings for Somatuline® in the Treatment of GEP-NET1s in the US with Priority Review and in Europe  Crawford Financial Planning1 day ago
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BioWest Expo Showcases New Technologies, Products & Services for 300+ Attendees; Features FDA Commissioner Hamburg as Lead Keynote

Exhibitors will be showcasing up to 40 new technologies, products and services at the 2014 BioWest Conference & Expo, the Rocky Mountain Region's premier medical device and biotechnology conference organized by the Colorado BioScience Association ...
 Wall Street Select1 hour ago
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PharmaAsia

UCB Says FDA Approves SNDA For VIMPAT

UCB announced that the U.S. Food and Drug Administration has approved a supplemental new drug application (sNDA) for VIMPAT (lacosamide) C-V as monotherapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older.
 RTTNews.com1 day ago New indication for VIMPAT® (lacosamide): UCB's anti-epileptic drug approved by FDA as monotherapy in the treatment of patients with partial-onset seizures  PR Newswire1 day ago FDA Approves UCB's Vimpat as Monotherapy  PharmaAsia11 hours ago FDA approves UCBs Vimpat as monotherapy  Big News Network17 hours ago
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Ligand Pharmaceuticals: FDA to OK GlaxoSmithKline Promacta/Revolade [Health & Beauty Close - Up]

[September 02, 2014] (Health & Beauty Close - Up Via Acquire Media NewsEdge) Ligand Pharmaceuticals reported that its partner GlaxoSmithKline has received approval of a supplemental New Drug Application for the once-daily use of ...
 TMC Net8 hours ago
DNA

Residential areas new dens to hide gutka: FDA

PUNE: Officials of the Food and Drugs Administration (FDA) have seized gutka worth Rs 6.16 lakh in Pune district since the ban was renewed for one more year from July 20 this year. According to the officials, in many cases, gutka has been recovered ...
 Times of India17 hours ago Food and Drugs Administration renews gutka ban for the third time  DNA1 month ago

US FDA grants fast track status to Pfizer's clostridium difficile vaccine candidate

The US Food and Drug Administration (FDA) has granted Fast Track designation to the Pfizer's investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090). Currently in phase 2 clinical development, the vaccine candidate is ...
 PharmaBiz1 day ago Pfizer's Investigational Vaccine Candidate for Clostridium difficile Receives FDA Fast Track Designation  Drugs.com9 hours ago
Business Standard

Wockhardt's two anti infective drugs get QIDP status from US FDA

Wockhardt has received the coveted Qualified Infectious Disease Product (QIDP) status from US FDA for two anti infective drugs viz., WCK 771 and WCK 2349. QIDP status is granted to drugs which act against pathogens which have a high degree of unmet ...
 PharmaBiz1 day ago Wockhardt's infective drugs receive QIDP status from US FDA  Express Pharma1 day ago Wockhardt's WCK 771 and WCK 2349 recieve QIDP status from US FDA  Economic Times1 day ago US FDA fast-tracks approval for Wockhardt drugs  Business Standard2 days ago
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InnoPharma's decitabine for injection receives US FDA approval for treatment of patients with MDS

InnoPharma, Inc., a privately held, sterile product development company, announced that its Abbreviated New Drug Application (ANDA) for decitabine for injection, a generic version of Eisai Inc.'s Dacogen has received the approval from the US Food ...
 PharmaBiz1 day ago InnoPharma wins US FDA approval of Decitabine for Injection for treating myelodysplastic syndromes  Individual.com1 day ago FDA approves InnoPharma's decitabine for injection to treat myelodysplastic syndromes  Pharmaceutical Business Review1 day ago FDA approves InnoPharmas decitabine for injection to treat myelodysplastic syndromes  Big News Network4 hours ago
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