Regulation - North America, Respiratory and Pulmonary

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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

Surprise US FDA approval for United Thera’s Orenitram ER for PAH

Surprise US FDA approval for United Thera’s Orenitram ER for PAH

23-12-2013

In what was seen by some observers as unexpected, the US Food and Drug Administration has approved United…

BiotechnologyNorth AmericaOrenitramRegulationRespiratory and PulmonaryTreprostinilUnited Therapeutics

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

FDA allows OTC of Sanofi’s Nasacort

FDA allows OTC of Sanofi’s Nasacort

13-10-2013

The US Food and Drug Administration has approved Sanofi’s Nasacort Allergy 24HR nasal spray as an over-the-counter…

ChattemNasacort AQNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySanofi

FDA approves Bayer’s Adempas; firm accelerates drug candidates

FDA approves Bayer’s Adempas; firm accelerates drug candidates

09-10-2013

The US Food and Drug Administration late yesterday approved Adempas (riociguat), developed by German…

AdempasBayerCardio-vascularcopanlisibfinerenoneNorth AmericaOncologyPharmaceuticalRegulationResearchRespiratory and PulmonaryWomen's Health

US FDA backs updated product specifications for Surfaxin

04-10-2013

Discovery Laboratories says that the US Food and Drug Administration has agreed to the company's updated…

Discovery LaboratoriesNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySurfaxin

Bayer gains two orphan drug designations for riociguat

Bayer gains two orphan drug designations for riociguat

26-09-2013

Bayer’s investigational drug riociguat has been granted two orphan drug designations by the US Food…

BayerNorth AmericaPharmaceuticalRegulationRespiratory and Pulmonaryriociguat

FDA advisory panel gives thumbs up for Anoro Ellipta approval

11-09-2013

There was a bit of good news for UK pharma giant GlaxoSmithKline yesterday (LSE: GSK) and partner USA-based…

Anoro ElliptaGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTheravance

GSK's Anoro Ellipta shows efficacy in COPD, say FDA briefing papers

09-09-2013

UK drug major GlaxoSmithKline's (LSE: GSK) Anoro Ellipta (vilanterol/umeclidinium) to treat chronic obstructive…

Anoro ElliptaBreo ElliptaGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTheravance

Forest Labs and Almirall opt to delay US filing for combo COPD drug

15-08-2013

USA-based Forest Laboratories (NYSE: FRX) and Spain's largest drugmaker Almirall (ALM:MC) said late yesterday…

aclidiniumAlmirallForest LaboratoriesformoterolNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTudorza Pressair

Bayer's PAH/CTEPH drug gets unanimous backing from FDA advisory panel

07-08-2013

In what was largely expected following this week's briefing papers from US Food and Drug Administration…

AdempasBayerNorth AmericaPharmaceuticalRegulationRespiratory and Pulmonaryriociguat

FDA staffers back riociguat approval, but with modified dose

05-08-2013

On Tuesday (August 6), the US Food and Drug Administration's Renal Drugs Advisory Committee will discuss…

ActelionAdempasBayerNorth AmericaOpsumitPharmaceuticalRegulationRespiratory and PulmonaryriociguatTracleer

FDA advisory committee backs approval of Sanofi drug for OTC

01-08-2013

The US Food and Drug Administration's Nonprescription Drugs Advisory Committee (NDAC) voted 10 to six,…

Nasacort AQNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySanofiTeva Pharmaceutical Industries

FDA approves Theravance and GSK's Breo Ellipta to treat COPD

13-05-2013

The US Food and Drug Administration on Friday (May 10) approved Breo Ellipta (fluticasone furoate, an…

BiotechnologyBreo ElliptaGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySkyepharmaTheravance Biopharma

FDA advisory panel backs approval of COPD drug Breo Ellipta

18-04-2013

Having earlier this week been presented with ambivalent briefing papers, the US Food and Drug Administration's…

Breo ElliptaGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTheravance

USA FDA seeks clarification on Discovery Labs' Surfaxin; issues briefing papers on GSK's Breo Ellipta

15-04-2013

US biotech firm Discovery Laboratories (Nasdaq: DSCO) says that the Food and Drug Administration has…

Breo ElliptaDiscovery LaboratoriesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySurfaxinTheravance

Bayer's PAH drug candidate riociguat gets US priority review; Sativex rescheduled in UK

08-04-2013

The US Food and Drug Administration has granted priority review to German drug major Bayer's (BAYN: DE)…

BayerEuropeGW PharmaceuticalsNeurologicalNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryriociguatSativex

Regulatory updates for Tris Pharma's Karbinal; GSK's four-strain seasonal flu vaccine

03-04-2013

US drug delivery specialist Tris Pharma says that the US Food and Drug Administration has approved its…

Anti-viralsEuropeFluarixGlaxoSmithKlineInflusplit TetraKarbinalNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTris Pharma

Actavis wins generic Pulmicort Respules case; challenges AbbVie patent

02-04-2013

US generic drugs maker Actavis (NYSE: ACT) has confirmed that the US District Court for the District…

AbbVieActavisAndroGelAstraZenecaGenericsMarkets & MarketingMen's HealthNorth AmericaPatentsPulmicort RespulesRegulationRespiratory and Pulmonary

FDA approves Novartis' TOBI Podhaler and Cangene's first Botulism Antitoxin heptavalent

24-03-2013

The US Food and Drug Administration on Friday approved Swiss drug major Novartis' (NOVN: VX) TOBI Podhaler…

Antibiotics and Infectious diseasesBotulism antitoxinCangeneNorth AmericaNovartisPharmaceuticalRegulationRespiratory and PulmonaryTobi Podhaler

US FDA calls for new trial with Pharmaxis' CF drug Bronchitol

19-03-2013

Australian pharma company Pharmaxis (ASX: PXS) says it has received a complete response letter from the…

BronchitolNorth AmericaPharmaceuticalPharmaxisRare diseasesRegulationRespiratory and Pulmonary

Briefs: Sanofi to up stake in Regeneron; Bayer files for riociguat approval

12-02-2013

US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) saw its shares rise 4.8% to $173.84 in early trading…

BayerBiotechnologyEuropeFinancialMergers & AcquisitionsNorth AmericaPharmaceuticalRegeneronRegulationRespiratory and PulmonaryriociguatSanofi

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