Regulation - Regulation, Respiratory and Pulmonary

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New Zealand's PHARMAC funds four new medicines as part of major agreement with Novartis

New Zealand's PHARMAC funds four new medicines as part of major agreement with Novartis

20-10-2014

New Zealand's Pharmaceutical Managment Agency PHARMAC has agreed to fund four new medicines for which…

Antibiotics and Infectious diseasesCardio-vascularglycopyrroniumindacaterolNew ZealandNovartisOmalizumabPharmaceuticalRegulationRespiratory and PulmonaryTobramycin

US FDA approves Genentech’s Esbriet and Boehringer Ingelheim’s Ofev for IPF

US FDA approves Genentech’s Esbriet and Boehringer Ingelheim’s Ofev for IPF

16-10-2014

The US Food and Drug Administration has approved Esbriet (pirfenidone), from Roche subsidiary Genentech,…

Boehringer IngelheimEsbrietGenentechnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

New Zealand approval of Novartis multiproduct proposal

10-10-2014

New Zealand’s Pharmaceutical Management Agency PHARMAC has announced the approval of an agreement with…

NeurologicalNew ZealandOncologyPharmaceuticalRegulationRespiratory and Pulmonary

Almirall’s aclidinium bromide/formoterol backed by EMA/CHMP to treat COPD

Almirall’s aclidinium bromide/formoterol backed by EMA/CHMP to treat COPD

26-09-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a…

aclidiniumAlmirallAstraZenecaBrimica GenuairDuaklir GenuairEuropeformoterolPharmaceuticalRegulationRespiratory and Pulmonary

Boehringer’s Spiriva Respimat OKed by FDA for maintenance treatment of COPD

Boehringer’s Spiriva Respimat OKed by FDA for maintenance treatment of COPD

25-09-2014

German family-owned pharma major Boehringer Ingelheim Pharmaceuticals has received US Food and Drug Administration…

Boehringer IngelheimPharmaceuticalRegulationRespiratory and PulmonarySpirivaUSA

FDA accepts Tuzistra XR NDA for full review

FDA accepts Tuzistra XR NDA for full review

15-09-2014

The US Food and Drug Administration has confirmed that the New Drug Application for Tuzistra XR, a prescription…

LicensingPharmaceuticalRegulationRespiratory and PulmonaryTris PharmaTuzistraUSAVernalis

Prosonix’ generic version of GSK’s Flixotide Evohaler under review in EU

Prosonix’ generic version of GSK’s Flixotide Evohaler under review in EU

02-09-2014

UK-based Prosonix, a speciality pharmaceutical company developing a portfolio of inhaled respiratory…

EuropeEvohalerFinancialFluticasone PropionateGenericsGlaxoSmithKlineMylanProsonixRegulationRespiratory and Pulmonary

US FDA backs approval of GSK’s Arnuity Ellipta for asthma

US FDA backs approval of GSK’s Arnuity Ellipta for asthma

21-08-2014

UK pharma giant GlaxoSmithKline revealed late yesterday that the US Food and Drug Administration has…

Arnuity ElliptaGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryUSA

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

Vertex received European approval for CF drug Kalydeco

Vertex received European approval for CF drug Kalydeco

01-08-2014

US biotech firm Vertex Pharmaceuticals has announced that the European Commission has approved Kalydeco…

BiotechnologyCommittee for Medicinal Products for Human UseCystic fibrosisKalydecoPharmaceuticalRegulationRespiratory and PulmonaryUSAVertex Pharmaceuticals

FDA approves Boehringer’s Striverdi Respimat for COPD

FDA approves Boehringer’s Striverdi Respimat for COPD

01-08-2014

The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s…

Boehringer IngelheimPharmaceuticalPulmonologyRegulationRespiratory and PulmonaryStriverdi RespimatUSA

US breakthrough status for InterMune’s pirfenidone

US breakthrough status for InterMune’s pirfenidone

21-07-2014

US biotech firm InterMune’s Esbriet (pirfenidone) has been granted Breakthrough Therapy designation…

BiotechnologyEsbrietFood and Drug AdministrationInterMunepirfenidoneRare diseasesRegulationRespiratory and PulmonaryUSA

US breakthrough designation in IPF for Boehringer’s nintedanib

US breakthrough designation in IPF for Boehringer’s nintedanib

17-07-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation for German family-owned…

Boehringer IngelheimnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

FDA accepts Teva’s NDA for albuterol MDPI

FDA accepts Teva’s NDA for albuterol MDPI

15-07-2014

Israel-based generic giant Teva Pharmaceuticals Industries says that the US Food and Drug Administration…

albuterolExercise-induced bronchospasmGenericsPulmonologyRegulationRespiratory and PulmonaryTeva Pharmaceutical IndustriesUSA

FDA accepts Boehringer’s nintedanib NDA; granted priority review for IPF

FDA accepts Boehringer’s nintedanib NDA; granted priority review for IPF

02-07-2014

The US subsidiary of German family-owned drug major Boehringer Ingelheim says that the New Drug Application…

Boehringer IngelheimnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

Boehringer submits tiotropium + olodaterol Respimat for European approval in COPD

Boehringer submits tiotropium + olodaterol Respimat for European approval in COPD

02-07-2014

German family-owned pharma major Boehringer Ingelheim says it has submitted Marketing Authorization Applications…

Boehringer IngelheimEuropePharmaceuticalRegulationRespiratory and Pulmonarytiotropium + olodaterol Respimat

GSK and Theravance submit US sNDA for Breo Ellipta in asthma

GSK and Theravance submit US sNDA for Breo Ellipta in asthma

30-06-2014

US pharma giant GlaxoSmithKline and US partner Theravance have submitted a supplemental New Drug Application…

Breo ElliptaGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravanceUSA

ALK’s Japanese partner posts mixed results for house dust mite SLIT-tablet

ALK’s Japanese partner posts mixed results for house dust mite SLIT-tablet

16-06-2014

Denmark-based allergy specialist ALK Abello partner for Japan, Torii Pharmaceutical, has completed its…

ALK AbelloJapanPharmaceuticalRegulationResearchRespiratory and PulmonarySLIT-tabletTorii Pharma

EMA accepts Boehringer’s accelerated marketing application for nintedanib in IPF

EMA accepts Boehringer’s accelerated marketing application for nintedanib in IPF

05-06-2014

German family-owned pharma major Boehringer Ingelheim said this morning that the European Medicines Agency…

Boehringer IngelheimEuropenintedanibPharmaceuticalRegulationRespiratory and Pulmonary

GlaxoSmithKline and Theravance’s Anoro Ellipta gains approval in EU

GlaxoSmithKline and Theravance’s Anoro Ellipta gains approval in EU

09-05-2014

The European Commission has granted marketing authorization for UK pharma giant GlaxoSmithKline and partner…

Anoro ElliptaEuropeGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravance

US FDA approves GSK’s Incruse Ellipta for COPD

US FDA approves GSK’s Incruse Ellipta for COPD

01-05-2014

The US Food and Drug Administration has approved UK pharma major GlaxoSmithKline’s Incruse (umeclidinium)…

Chronic lower respiratory diseasesCOPDGlaxoSmithKlineIncruseIncruse ElliptaMajorMedicinePharmaceuticalPulmonologyRegulationRespiratory and PulmonaryUKUSA

EU approval for Teva’s DuoResp Spiromax for asthma and COPD

EU approval for Teva’s DuoResp Spiromax for asthma and COPD

30-04-2014

The European Commission has granted marketing authorization for Israel-based Teva Pharmaceutical Industries’…

DuoResp SpiromaxEuropeGenericsRegulationRespiratory and PulmonaryTeva Pharmaceutical Industries

Canadian approval for GSK’s Incruse Ellipta as a treatment for COPD

17-04-2014

UK pharma giant GlaxoSmithKline says that Incruse Ellipta (umeclidinium) has received market authorization…

CanadaGlaxoSmithKlineIncruse ElliptaNorth AmericaPharmaceuticalRegulationRespiratory and Pulmonary

Pharmacovigilance Risk Assessment Committee April meeting highlights

Pharmacovigilance Risk Assessment Committee April meeting highlights

11-04-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) gave a recommendation…

Cardio-vascularEuropeMen's HealthNeurologicalPharmaceuticalRegulationRespiratory and Pulmonary

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