Pharmaceutical - Respiratory and Pulmonary, Regulation

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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 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 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

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

Forest and Almirall get FDA feedback on fixed dose combo of aclidinium and formoterol

Forest and Almirall get FDA feedback on fixed dose combo of aclidinium and formoterol

09-04-2014

US drugmaker Forest Laboratories and partner Almirall, Spain’s largest pharma company, say they have…

aclidiniumAlmirallForest LaboratoriesformoterolNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryUSA

Bayer’s Adempas gains EU clearance for two forms of PAH

Bayer’s Adempas gains EU clearance for two forms of PAH

31-03-2014

Following a previous positive opinion from the European Medicines Agency’s advisory committee, the…

AdempasBayerEuropePharmaceuticalRegulationRespiratory and Pulmonary

Insmed’s mixed results from Ph II trial for treatment resistant NTM lung infections

27-03-2014

US-based Insmed has reported mixed results from its Phase II clinical trial of Arikayce, for the treatment…

Inflammatory diseasesInsmedPharmaceuticalRegulationRespiratory and PulmonaryUSA

Positive CHMP opinion for Teva’s DuoResp Spiromax for asthma and COPD

22-02-2014

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

AstraZenecaDuoResp SpiromaxPharmaceuticalRegulationRespiratory and PulmonarySymbicortTeva Pharmaceutical Industries

GSK receives positive CHMP opinion for COPD drug Incruse

GSK receives positive CHMP opinion for COPD drug Incruse

21-02-2014

GlaxoSmithKline has announced that the European Medicines Agency’s Committee for Medicinal Products…

GlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryUKumeclidinium

GSK and Theravance’s Anoro gets positive EMA panel backing for COPD

GSK and Theravance’s Anoro gets positive EMA panel backing for COPD

21-02-2014

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

Anoro ElliptaGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravance Biopharma

Minor added benefit of Novartis’ Ultibro/Xoterna Breezhaler in COPD, says IQWiG

Minor added benefit of Novartis’ Ultibro/Xoterna Breezhaler in COPD, says IQWiG

19-02-2014

In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG),…

GermanyNorthern EuropeNovartisPharmaceuticalPricingRegulationRespiratory and PulmonaryUltibro BreezhalerXoterna Breezhaler

EMA/CHMP gives Novartis positive opinion for Xolair; negative opinion on RLX030 to be appealed

EMA/CHMP gives Novartis positive opinion for Xolair; negative opinion on RLX030 to be appealed

24-01-2014

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given…

Cardio-vascularEuropeNovartisPharmaceuticalRegulationRespiratory and PulmonaryXolair

Japanese approval for Bayer’s riociguat for CTEPH

Japanese approval for Bayer’s riociguat for CTEPH

20-01-2014

German pharma major Bayer has received approval from the Ministry of Health, Labor and Welfare for riociguat,…

AdempasAsia-PacificBayerPharmaceuticalRegulationRespiratory and Pulmonaryriociguat

Sandoz receives Danish approval for AirFluSal Forspiro inhaler

Sandoz receives Danish approval for AirFluSal Forspiro inhaler

19-12-2013

Swiss drug major Novartis' (NOVN: VX) generics unit Sandoz has received Danish marketing authorization…

DenmarkPharmaceuticalRegulationRespiratory and PulmonarySandozVectura

US FDA approves GSK/Theravance’s Anoro Ellipta for COPD

US FDA approves GSK/Theravance’s Anoro Ellipta for COPD

19-12-2013

The US Food and Drug Administration late yesterday approved Anoro Ellipta (umeclidinium and vilanterol…

Anoro ElliptaGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTheravance

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