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FDA issues CRL over Acorda's Plumiaz marketing application

FDA issues CRL over Acorda's Plumiaz marketing application

02-05-2014

There was disappointment for US biotech firm Acorda Therapeutics, which says it has received a complete…

Acorda TherapeuticsBiotechnologyNeurologicalPlumiazRegulationUSA

Genzyme to resubmit Lemtrada NDA for FDA review

Genzyme to resubmit Lemtrada NDA for FDA review

07-04-2014

Genzyme, the biotech subsidiary of French drug major Sanofi, said this morning that, following “constructive…

BayerBiotechnologyLemtradaNeurologicalNorth AmericaRegulationSanofiUSA

FDA delays approval of Biogen Idec’s MS drug Plegridy

FDA delays approval of Biogen Idec’s MS drug Plegridy

18-03-2014

The US Food and Drug Administration has extended the initial Prescription Drug User Fee Act date for…

Biogen IdecBiotechnologyNeurologicalNorth AmericaPlegridyRegulationUSA

RedHill Biopharma and IntelGenx respond to CRL on rizatriptan

04-03-2014

Emerging Israeli biotech firm RedHill Biopharma, together with Canadian drug delivery specialist IntelGenx,…

BiotechnologyIntelGenxNeurologicalNorth AmericaRedHill BiopharmaRegulationUSA

Neurocrine rockets on positive Phase II data for tardive dyskinesia treatment

08-01-2014

Shares of Neurocrine Biosciences were up almost 80% yesterday after it announced that NBI-98854, a small…

BiotechnologyNeurocrine BiosciencesNeurologicalResearchUSA

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Eleven Biotherapeutics

Eleven Biotherapeutics

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