FDA grants fast track designation for Celyad’s ischemic heart failure therapy, C-Cure

11 May 2017 - Designation granted on the strength of the evidence in the subset of patients that were responders ...

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GSK escapes Advair hit for now as second generic bid fails

11 May 2017 - GlaxoSmithKline is likely to escape generic competition to its blockbuster lung drug Advair in the United ...

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TherapeuticsMD receives complete response letter from FDA for TX-004HR new drug application

8 May 2017 - No approvability issues identified by FDA related to efficacy or CMC. ...

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FDA grants fast track designation to XyloCor Therapeutics lead candidate XC001

8 May 2017 - XyloCor Therapeutics announced that the U.S. FDA has granted fast track designation to its lead product candidate ...

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Axsome Therapeutics receives FDA fast track designation for AXS-05 for Alzheimer’s disease agitation

8 May 2017 - Axsome Therapeutics received fast track designation from the U.S. FDA for AXS-05 for the treatment of agitation ...

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Sangamo Therapeutics announces special regulatory designations from the FDA for three clinical programs

4 May 2017 - Fast track designation for SB-FIX in vivo genome editing treatment for haemophilia B. ...

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Pfizer announces U.S. FDA filing acceptance of supplemental new drug application for Xeljanz (tofacitinib citrate) for the treatment of adult patients with active psoriatic arthritis

3 May 2017 - Pfizer announced today that the US FDA has accepted for review the supplemental new drug application for ...

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Atlantic Healthcare initiates FDA rolling submission of its new drug application for alicaforsen in the treatment of pouchitis

1 May 2017 - Filing of the nonclinical package marks a key milestone in the process towards obtaining marketing approval ...

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Sunesis Pharmaceuticals announces withdrawal of European marketing authorisation application for vosaroxin as a treatment for relapsed/refractory AML

1 May 2017 - Company’s primary development focus is non-covalent reversible BTK inhibitor SNS-062. ...

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Kiadis Pharma announces filing of marketing authorisation with the European Medicines Agency for ATIR101 in blood cancers

26 April 2017 - Kiadis Pharma today announces it has submitted a marketing authorisation application to the EMA for its ...

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Lilly gives no time frame on arthritis drug delay; shares fall

25 April 2017 - Eli Lilly said Tuesday provided no new information on how long U.S. regulators might delay approval ...

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Orexigen Therapeutics announces new drug submission for Contrave in Canada

25 April 2017 - Orexigen Therapeutics today announced that Health Canada has completed its screening phase and accepted for review ...

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EMA publishes withdrawal assessment report for Graspa

25 April 2017 - On 14 November 2016, Erytech Pharma officially notified the CHMP that it wishes to withdraw its application ...

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Epizyme announces tazemetostat fast track designation for follicular lymphoma and plenary session on Phase 2 NHL data at ICML

25 April 2017 - Interim efficacy and safety data from ongoing Phase 2 study in follicular lymphoma and DLBCL selected for ...

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EMA publishes withdrawal assessment report for Zioxtenzo

25 April 2017 - On 18 January 2017, Sandoz officially notified the CHMP that it wishes to withdraw its application ...

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