Regulation - North America, Pharmaceutical

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FDA backs Janssen’s Sylvant for rare disease

24-04-2014

The US Food and Drug Administration yesterday approved Johnson & Johnson subsidiary Janssen Biotech’s…

Janssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalRare diseasesRegulationsiltuximabSylvantUSA

Lilly's Cyramza first FDA-approved drug for advanced gastric cancer after prior chemo

22-04-2014

The US Food and Drug Administration has approved pharma major Eli Lilly’s Cyramza (ramucirumab) as…

CyramzaEli LillyNorth AmericaOncologyPharmaceuticalRegulationUSA

AbbVie files NDA for oral, interferon-free treatment of hepatitis C

22-04-2014

US drugmaker AbbVie has submitted its New Drug Application to the US Food and Drug Administration for…

AbbVieAnti-viralsEnanta PharmaceuticalsFinancialNorth AmericaPharmaceuticalRegulationUSA

FDA approves Merck’s Ragwitek for short ragweed pollen allergies

18-04-2014

The US Food and Drug Administration has approved US pharma giant Merck & Co’s Biological License Application…

ALK AbelloImmunologicalsMerck & CoNorth AmericaPharmaceuticalRagwitekRegulationUSA

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

FDA finally OKs GlaxoSmithKline’s Tanzeum to treat type 2 diabetes

FDA finally OKs GlaxoSmithKline’s Tanzeum to treat type 2 diabetes

16-04-2014

UK pharma giant GlaxoSmithKline yesterday received the much anticipated approval from the US Food and…

albiglutideDiabetesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationTanzeumUSA

NDA filing for empagliflozin and linagliptin combo accepted by FDA

NDA filing for empagliflozin and linagliptin combo accepted by FDA

14-04-2014

The US Food and Drug Administration has accepted the filing of the New Drug Application for the investigational…

Boehringer IngelheimDiabetesEli LillyempagliflozinJardiancelinagliptinNorth AmericaPharmaceuticalRegulationTradjentaUSA

Extended US market exclusivity for BioMarin's rare disease drug Kuvan

14-04-2014

US drugmaker BioMarin Pharmaceutical says that the Food and Drug Administration has granted Kuvan (sapropterin…

BioMarin PharmaceuticalKuvanNorth AmericaPharmaceuticalRare diseasesRegulationUSA

Impax Pharma resubmits NDA for Rytary

Impax Pharma resubmits NDA for Rytary

11-04-2014

Impax Laboratories’ branded products division has resubmitted the New Drug Application for Rytary (carbidopa…

Impax LaboratoriesNeurologicalNorth AmericaPharmaceuticalRegulationRytaryUSA

FDA clinical hold on Halozyme’s PEGPH20 pancreatic cancer trial

FDA clinical hold on Halozyme’s PEGPH20 pancreatic cancer trial

09-04-2014

US biopharma firm Halozyme Therapeutics says that the US Food and Drug Administration informed the company…

Halozyme TherapeuticsNorth AmericaOncologyPharmaceuticalRegulationResearchUSA

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

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

07-04-2014

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

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulationUSA

Bristol-Myers Squibb files for US approval of daclatasvir and asunaprevir for hepatitis C

Bristol-Myers Squibb files for US approval of daclatasvir and asunaprevir for hepatitis C

07-04-2014

US pharma major Bristol-Myers Squibb has submitted New Drug Applications with the US Food and Drug Administration…

Anti-viralsasunaprevirBristol-Myers SquibbdaclatasvirNorth AmericaPharmaceuticalRegulationUSA

MannKind’s diabetes drug Afrezza recommended by FDA advisory

02-04-2014

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee yesterday…

AfrezzaDiabetesMannKindNorth AmericaPharmaceuticalRegulationUSA

Unanimous FDA advisory panel backing for Cubist’s Sivextro

Unanimous FDA advisory panel backing for Cubist’s Sivextro

02-04-2014

The US Food and Drug Administration’s Anti-Infective Drugs Advisory Committee on Monday voted unanimously…

Antibiotics and Infectious diseasesCubist PharmaceuticalsNorth AmericaPharmaceuticalRegulationSivextrotedizolidUSA

FDA advisory unanimously recommends Durata’s Dalvance

FDA advisory unanimously recommends Durata’s Dalvance

01-04-2014

The US Food and Drug Anti-Infective Drugs Advisory Committee voted 12 to 0 that Durata Therapeutics’…

Antibiotics and Infectious diseasesDalvanceDermatologicalsDurata TherapeuticsNorth AmericaPharmaceuticalRegulationUSA

US FDA advisory panel votes against approval of Novartis’ AHF drug

US FDA advisory panel votes against approval of Novartis’ AHF drug

28-03-2014

The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee yesterday voted…

Cardio-vascularNorth AmericaNovartisPharmaceuticalReasanzRegulationserelaxinUSA

Pfizer’s vaccine candidate bivalent rLP2086 gains “Breakthrough” status

Pfizer’s vaccine candidate bivalent rLP2086 gains “Breakthrough” status

20-03-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation to pharma behemoth Pfizer’s…

North AmericaPfizerPharmaceuticalRegulationrLP2086USAVaccines

FDA approves Impavido to treat tropical disease leishmaniasis

FDA approves Impavido to treat tropical disease leishmaniasis

20-03-2014

The US Food and Drug Administration yesterday approved Canada-headquartered Paladin Impavido (miltefosine)…

Endo Health SolutionsImpavidoNorth AmericaPaladin LabsPharmaceuticalRegulationUSA

Astellas and Medivation file sNDA for new Xtandi indication

Astellas and Medivation file sNDA for new Xtandi indication

18-03-2014

Japanese drug major Astellas Pharma and US partner Medivation have filed a supplemental New Drug Application…

Astellas PharmaMedivationNorth AmericaOncologyPharmaceuticalRegulationUSAXtandi

US FDA approves Pierre Fabre’s Hemangeol for infantile hemangioma

US FDA approves Pierre Fabre’s Hemangeol for infantile hemangioma

18-03-2014

Pierre Fabre Dermatologie has obtained marketing authorization from the US Food and Drug Administration…

DermatologicalsHemangeolNorth AmericaPharmaceuticalPierre FabreRegulationUSA

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

16-03-2014

The US Food and Drug Administration has approved pharma major Bristol-Myers Squibb’s supplemental New…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulationUSA

Mallinckrodt gains FDA approval for Xartemis XR

Mallinckrodt gains FDA approval for Xartemis XR

12-03-2014

The US Food and Drug Administration has approved Ireland-headquartered specially drugmaker Mallinckrodt’s…

DepomedMallinckrodtNeurologicalNorth AmericaPharmaceuticalRegulationUSAXartemis XR

FDA accepts Lundbeck NDA for IV carbamazepine

FDA accepts Lundbeck NDA for IV carbamazepine

10-03-2014

The US subsidiary of Danish CNS specialist Lundbeck says that the Food and Drug Administration has accepted…

CarbamazepineCarbellaFinancialLigand PharmaceuticalsLundbeckNeurologicalNorth AmericaPharmaceuticalRegulationUSA

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