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Tetraphase reports positive oral dosing data in Phase III of eravacycline

Tetraphase reports positive oral dosing data in Phase III of eravacycline

03-09-2014

US pharma company Tetraphase Pharmaceutical has announced positive top-line data from the lead-in portion…

Antibiotics and Infectious diseasesComplicated urinary tract infectionseravacyclineLevofloxacinPharmaceuticalResearchTetraphase PharmaceuticalsUS Food and Drug AdministrationUSA

Ipsen receives priority review for sNDA for Somatuline

Ipsen receives priority review for sNDA for Somatuline

01-09-2014

French drugmaker Ipsen has received priority review for its supplemental New Drug Application from the…

Gastroenteropancreatic neuroendocrine tumorsIpsenOncologyPharmaceuticalRegulationSomatulineUS Food and Drug AdministrationUSA

India's Piramal will divert resources from early-stage research to advanced-stage molecules

India's Piramal will divert resources from early-stage research to advanced-stage molecules

29-08-2014

Indian pharma company Piramal Enterprises has announced its intention to stop early-stage research in…

IndiaMetabolic disordersPharmaceuticalPiramal EnterprisesPiramal HealthcareProductionResearchSwati PiramalUS Food and Drug Administration

Takeda's 10-year study finds no link between pioglitazone and bladder cancer

Takeda's 10-year study finds no link between pioglitazone and bladder cancer

29-08-2014

Japan’s largest drugmaker Takeda has completed the post-marketing commitment and data submissions to…

Bladder cancerEuropean Medicines AgencyJapanOncologyPharmaceuticalPioglitazoneRegulationResearchTakeda PharmaceuticalsUS Food and Drug Administration

FDA panel recommends Boehringer drug for the maintenance treatment of COPD

FDA panel recommends Boehringer drug for the maintenance treatment of COPD

15-08-2014

There was good news late yesterday for German family-owned pharma major Boehringer Ingelheim, when an…

Boehringer IngelheimPharmaceuticalRegulationRespiratory and PulmonarySpirivatiotropiumUS Food and Drug AdministrationUSA

FDA modifies Tekmira's TKM-Ebola clinical hold to partial hold

FDA modifies Tekmira's TKM-Ebola clinical hold to partial hold

08-08-2014

Canadian RNA interference (RNAi) therapeutics developer Tekmira Pharmaceuticals revealed yesterday that…

Anti-viralsEbolaMicrobiologyPharmaceuticalRegulationResearchTekmira PharmaceuticalsTKM-EbolaUS Food and Drug AdministrationUSA

Newly-approved drugs have one in three chance of black box warning or withdrawal

Newly-approved drugs have one in three chance of black box warning or withdrawal

05-08-2014

Newly-approved drugs have a one in three chance of acquiring a black box warning, or being withdrawn…

Boxed warningCassie FrankPharmaceuticalPharmaceutical industryPublic CitizenRegulationUS Food and Drug AdministrationUSA

US and European orphan status for AbbVie’s glioblastoma candidate

US and European orphan status for AbbVie’s glioblastoma candidate

04-08-2014

Both the European Medicines Agency and the US Food and Drug Administration have granted orphan drug designation…

AbbVieABT-414Brain tumorEuropeGlioblastoma multiformeMarkets & MarketingOncologyPharmaceuticalRare diseasesRegulationUS Food and Drug AdministrationUSA

US FDA grants Valeant approval for Jublia NDA

US FDA grants Valeant approval for Jublia NDA

09-06-2014

Canadian drugmaker Valeant Pharmaceuticals International’s US subsidiary has received approval from…

CanadaDermatologicalsefinaconazoleJubliaPharmaceuticalRegulationUS Food and Drug AdministrationValeant Pharmaceuticals

Boehringer Ingelheim’s volasertib granted orphan drug designation for AML

Boehringer Ingelheim’s volasertib granted orphan drug designation for AML

17-04-2014

The US Food and Drug Administration and the European Commission have granted German family-owned drug…

Boehringer IngelheimEuropeGermanyHealth Medical PharmaMajorMedicineOncologyPharmaceuticalPharmacologyRegulationUS Food and Drug AdministrationUSAvolasertib

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