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Posts tagged: nda

EU and U.S. regulatory authorities accept Biogen Idec’s BG-12 NDA for review

May 10, 2012
Today Biogen Idec announced that U.S. and EU regulatory authorities have accepted the company's marketing applications for the review of BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of multiple sclerosis.

Tarsa advances OSTORA NDA filing through $28M Series B financing

March 17, 2012
Tarsa Therapeutics, Inc. today announced completion of a $28 million Series B equity financing led by new investor Foresite Capital.

Avedro submits VibeX/KXL System NDA with FDA to treat keratoconus, corneal ectasia

March 9, 2012
Avedro, Inc. announced today that the Company submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for its VibeX (riboflavin ophthalmic solution) /KXL System for the treatment of keratoconus and corneal ectasia following refractive surgery.

FDA grants Priority Review for Repligen’s SecreFlo NDA

February 21, 2012
Repligen Corporation announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the Company's new drug application (NDA) for SecreFlo for the improved detection of pancreatic duct abnormalities in patients with pancreatitis.

U.S. FDA accepts Pfizer’s tafamidis NDA for treatment of TTR-FAP

February 16, 2012
Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tafamidis meglumine, the company's investigational, novel, oral therapy for the treatment of Transthyretin Familial Amyloid Polyneuropathy.

FDA sets Feb. 9 for ODAC meeting to review CTI’s resubmitted pixantrone NDA

January 3, 2012
Cell Therapeutics, Inc. (CTI) announced today that on February 9, 2012 the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review CTI's resubmitted New Drug Application (NDA) for pixantrone for the treatment of relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) in patients who failed two or ...

Eisai resubmits NDA for perampanel to treat epilepsy-associated seizures

December 26, 2011
Eisai Inc. announced today that it resubmitted the New Drug Application (NDA) for the investigational AMPA-type glutamate receptor antagonist perampanel for partial-onset seizures associated with epilepsy to the U.S. Food and Drug Administration (FDA) on December 22, 2011.

FDA EMDAC schedules to review VIVUS’ Qnexa NDA for treatment of obesity

December 26, 2011
VIVUS, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review the Company's New Drug Application (NDA) for Qnexa for the treatment of obesity on February 22, 2012.

FDA accepts Pfizer’s tofacitinib NDA for review

December 21, 2011
Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tofacitinib (development code CP-690,550), an investigational novel, oral JAK inhibitor being studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

FDA accepts Vertex KALYDECO NDA for six-month Priority Review

December 16, 2011
Vertex Pharmaceuticals Incorporated announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for KALYDECOTM (ivacaftor) and granted the company's request for six-month Priority Review.

Salix submits Crofelemer NDA to FDA for treatment of HIV-associated diarrhea

December 14, 2011
Salix Pharmaceuticals, Ltd. today announced that the Company has submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for Crofelemer for the proposed treatment of HIV-associated diarrhea.

Onyx receives FDA Standard Review designation for carfilzomib NDA to treat RRMM

December 12, 2011
Onyx Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Standard Review designation to the New Drug Application (NDA) for carfilzomib for the potential treatment of patients with relapsed and refractory multiple myeloma.