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RSS Channel: Rxmed - New Drug Applications
New drug applications news from Rxmed. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.
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Radius Health Submits NDA to the U.S. FDA for Abaloparatide-SC for the Treatment of Postmenopausal Women with Osteoporosis
WALTHAM, Mass., March 30, 2016 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS) today announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for abaloparatideSC 80 mcg, an...

OPKO Receives Complete Response Letter from FDA for Rayaldee New Drug Application
MIAMI, March 30, 2016 --(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE: OPK) announces that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) to the Company's New Drug Application (NDA) for Rayaldee (calcifediol) as...

Lexicon Submits New Drug Application to FDA for Telotristat Etiprate for the Treatment of Carcinoid Syndrome
The Woodlands, Texas, March 30, 2016 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of telotristat...

FDA Advisory Committee Votes 12 to 2 That Benefits of Nuplazid (Pimavanserin) for the Treatment of Psychosis Associated with Parkinsons Disease Outweigh the Risks
SAN DIEGO--(BUSINESS WIRE)--Mar. 29, 2016-- Acadia Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system...

Newron Receives Complete Response Letter from US FDA for Xadago (safinamide)
MILAN, March 29, 2016 --(BUSINESS WIRE)--Newron Pharmaceuticals S.p.A. (Newron) (SIX: NWRN), a research and development company focused on novel CNS and pain therapies, and its partners Zambon S.p.A. and US WorldMeds announced today that a...

Anacor Pharmaceuticals Announces FDA Acceptance of NDA for Crisaborole Topical Ointment, 2% for the Treatment of Mild-to-Moderate Atopic Dermatitis
March 22, 2016 -- PALO ALTO, Calif.--(BUSINESS WIRE)-- Anacor Pharmaceuticals, Inc. (NASDAQ:ANAC) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Anacor's New Drug Application (NDA) seeking approval of...

Elite Announces U.S. FDA Priority Review Designation for SequestOx NDA
NORTHVALE, N.J., March 17, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today announced that the New Drug Application (NDA) for SequestOXTM (ELI-200), Elite's lead opioid abuse-deterrent candidate for...

FDA Rules Favorably On Efficacy Of Travivo (Gepirone ER) For Treatment Of Major Depressive Disorder
HOUSTON, March 17, 2016 /PRNewswire/ -- The Food and Drug Administration (FDA) Office of New Drugs (OND) today notified Fabre-Kramer Pharmaceuticals (Fabre-Kramer) that it has granted its appeal pursuant to the agency's Formal Dispute Resolution...

Aralez Resubmits to FDA New Drug Application for Yosprala
MILTON, Ontario, March 15, 2016 /PRNewswire/ -- Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) ("Aralez" or the "Company"), a global specialty pharmaceutical company, today announced that it has resubmitted to the U.S. Food and Drug...

Heron Therapeutics Provides Update on Sustol NDA
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Mar. 3, 2016-- Heron Therapeutics, Inc. (NASDAQ:HRTX), announced today that the U.S. Food and Drug Administration (FDA) has informed the Company that it anticipates concluding its review of the New Drug...

First Patient Dosed in Iclaprim Phase 3 Trials to Treat Skin Infections
March 2, 2016 -- Motif Bio plc (AIM: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announces the dosing of the first patient in two Phase 3 clinical trials of its lead antibiotic candidate...

Egalet Announces FDA Acceptance of New Drug Application for Arymo ER (Morphine Sulfate) Extended-Release Tablets
WAYNE, Pa., Feb. 29, 2016 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions,...

FDA Accepts Sanofi NDA for Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide
PARIS, Feb. 22, 2016 /PRNewswire/ -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1...

Spectrum Pharmaceuticals Announces FDA's Acceptance of NDA Filing for EOquin (apaziquone for intravesical instillation)
HENDERSON, Nev., February 19, 2016 --(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced...

Titan Pharmaceuticals Announces Notification of FDA Action Date Extension for Probuphine
SOUTH SAN FRANCISCO, CA February 19, 2016 Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) announced today that the U.S. Food and Drug Administration (FDA) has notified Titan and its development and commercialization partner Braeburn...

Catalyst Pharmaceuticals Receives Refusal to File Letter From the FDA on Its NDA for Firdapse
CORAL GABLES, Fla., Feb. 17, 2016 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today...

Portola Pharmaceuticals Announces BLA for Andexanet Alfa Accepted for Review by FDA
SOUTH SAN FRANCISCO, Calif., Feb. 17, 2016 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals (NASDAQ:PTLA), announced today that the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has accepted the...

FDAs Arthritis Advisory Committee Recommends Approval of Celltrions CT-P13, a Proposed Biosimilar Infliximab
INCHEON, South Korea, February 09, 2016 --(BUSINESS WIRE)-- Celltrion, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of all indications for...

CTI BioPharma Provides Update on Clinical Hold of Investigational Agent Pacritinib and NDA
SEATTLE, Feb. 9, 2016 /PRNewswire/ -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today provided an update regarding the clinical studies being conducted under the Company's Investigational New Drug ("IND") application for pacritinib....

Sarepta Therapeutics Receives Notification of PDUFA Extension for Eteplirsen
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 8, 2016-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) will require additional time to...