Regulation - Alexza Pharmaceutical


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Positive EU regulatory news for Alexza and Ferrer, but not Gentium


USA-based Alexza Pharmaceuticals (Nasdaq: ALXA) and Spanish partner Grupo Ferrer Internacional have received…

AdasuveAlexza PharmaceuticalBiotechnologydefibrotideEuropeFerrer InternacionalGentiumNephrology and HepatologyNeurologicalPharmaceuticalRegulation

Positive recommendations from EMA's CHMP for Selincro, Adasuve and Perjeta


Last week's deliberations of the European Medicines Agency's Committee for Medicinal Products for Human…

AdasuveAlexza PharmaceuticalBiotechnologyEuropeFerrer InternacionalLundbeckNeurologicalOncologyPerjetaPharmaceuticalRegulationRocheSelincro

FDA sets PDUFA date for Alexza's resubmission for Adasuve


Following two earlier rejections, the US Food and Drug Administration has now accepted Alexza Pharmaceuticals…

AdasuveAlexza PharmaceuticalFerrer InternacionalNeurologicalNorth AmericaPharmaceuticalRegulation

Alexza rockets on re-submission of Adasuve NDA


USA-based Alexza Pharmaceuticals (Nasdaq: ALXA) saw its shares soar 44.9% to close at $3.97 on Friday,…

AdasuveAlexza PharmaceuticalNeurologicalNorth AmericaPharmaceuticalRegulation

FDA again rejects Alexza's Adasuve, citing manufacturing deficiencies


California, USA-based Alexza Pharmaceuticals (Nasdaq: ALXA) revealed last week that it has received another…

AdasuveAlexza PharmaceuticalNeurologicalNorth AmericaPharmaceuticalRegulation

PDUFA goal date for Alexza’s Adasuve extended, as Public Citizen says drug should not be approved


US drug firm Alexza Pharmaceuticals (Nasdaq: ALXA) says that the US Food and Drug Administration will…

AdasuveAlexza PharmaceuticalNeurologicalNorth AmericaPharmaceuticalRegulation

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