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US FDA approves Teva’s generic TOBI

US FDA approves Teva’s generic TOBI


Teva Pharmaceutical Industries says that the US Food and Drug Administration has granted approval of…

Antibiotics and Infectious diseasesGenericsNovartisRare diseasesRegulationTeva Pharmaceutical IndustriesTobi

FDA grants "Breakthrough Therapy" status for Alexion's asfotase in HPP; issues CRL for Valeant's efinaconazole


US drugmaker Alexion Pharmaceuticals (Nasdaq: ALXN) says that the Food and Drug Administration has granted…

Alexion PharmaceuticalsAntibiotics and Infectious diseasesasfotase alfaefinaconazoleNorth AmericaPharmaceuticalRare diseasesRegulationValeant Pharmaceuticals

Preliminary NICE guidance negative on Pfizer's Xalkori for lung cancer; backs Colobreathe and Tobi Podhaler for CF


Much to the disappointment of the company, this morning (March 27), UK drugs watchdog the National Institute…

Antibiotics and Infectious diseasesColoBreatheEuropeForest LaboratoriesNovartisOncologyPfizerPharmaceuticalPricingRare diseasesRegulationTobi PodhalerXalkori

NICE "green light" for Novartis' Tobi Podhaler and Forest's Colobreathe


The UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE), in a final draft…

Antibiotics and Infectious diseasesColoBreatheEuropeForest LaboratoriesNovartisPharmaceuticalPricingRare diseasesRegulationTobi Podhaler

US FDA approvals for Signifor, raxibacumab and Iclusig


In a flurry of activity from the US Food and Drug Administration on Friday, the agency - which looks…

Antibiotics and Infectious diseasesAriad PharmaceuticalsGlaxoSmithKlineIclusigNorth AmericaNovartisOncologyPharmaceuticalRare diseasesraxibacumabRegulationSignifor

GlaxoSmithKline amends accord with Isis Pharma; gets FDA panel backing for raxibacumab


USA-based Isis Pharmaceuticals (Nasdaq: ISIS) says it has agreed to amend the clinical development plan…

Antibiotics and Infectious diseasesBiotechnologyFinancialGlaxoSmithKlineIsis PharmaceuticalsISIS-TTR.RXLicensingNorth AmericaPharmaceuticalRare diseasesraxibacumabRegulationResearch

GlaxoSmithKline pays $15 million to exercise option on Anacor’s novel antibiotic; and $5 million milestone to Isis Pharma


UK drugs giant GlaxoSmithKline says it has exercised its option to obtain an exclusive licence to develop…

Anacor PharmaceuticalAntibiotics and Infectious diseasesGlaxoSmithKlineIsis PharmaceuticalsLicensingPharmaceuticalRare diseasesResearch

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