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FDA backs added indication for GSK’s Promacta

FDA backs added indication for GSK’s Promacta

27-08-2014

The Food and Drug Administration has approved UK pharma giant GlaxoSmithKline’s supplemental New Drug…

GlaxoSmithKlineHematologyLigand PharmaceuticalsPharmaceuticalPromactaRare diseasesRegulationRevoladeUSA

US Administration to ensure women’s continued access to contraception coverage, while respecting religious-based objections

US Administration to ensure women’s continued access to contraception coverage, while respecting religious-based objections

25-08-2014

On Friday, the Obama Administration in the USA took several steps to help ensure women, whose coverage…

FinancialPharmaceuticalRegulationReproductiveUSA

ViiV Healthcare gains FDA approval for HIV drug Triumeq

ViiV Healthcare gains FDA approval for HIV drug Triumeq

23-08-2014

The US Food and Drug Administration has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine…

Anti-viralsGlaxoSmithKlinePfizerPharmaceuticalRegulationShionogiTriumeqUSAViiV Healthcare

US DEA publishes final rule to reschedule hydrocodone combination products

US DEA publishes final rule to reschedule hydrocodone combination products

22-08-2014

The US Drug Enforcement Administration (DEA) has today published in the Federal Register the Final Rule…

AnalgesiaPharmaceuticalRegulationUS Drug Enforcement AdministrationUSA

FDA expands indication for Eliquis to treatment of DVT and PE

FDA expands indication for Eliquis to treatment of DVT and PE

22-08-2014

US pharma majors Bristol-Myers Squibb and Pfizer late yesterday said that the US Food and Drug Administration…

Boehringer IngelheimCardio-vascularEliquisPfizerPharmaceuticalPulmonary embolismRegulationUSA

Lilly’s ixekizumab shows superiority over etanercept and placebo in Ph III

Lilly’s ixekizumab shows superiority over etanercept and placebo in Ph III

21-08-2014

US pharma major Eli Lilly’s investigational medicine ixekizumab was superior to etanercept and placebo…

Eli LillyInflammatory diseasesixekizumabPharmaceuticalRegulationResearch

Positive top-line Ph III results for Baxter’s BAX 855 in hemophilia A

Positive top-line Ph III results for Baxter’s BAX 855 in hemophilia A

21-08-2014

US drugmaker Baxter International has announced positive results from its Phase III pivotal clinical…

AdvateBAX 855Baxter InternationalHematologyPharmaceuticalRegulationResearch

Public Citizen expert slams aspects of FDA draft drug labeling guidance

Public Citizen expert slams aspects of FDA draft drug labeling guidance

21-08-2014

The US Food and Drug Administration recently issued draft guidance that would let the pharmaceutical…

PharmaceuticalRegulationUSA

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

IQWiG finds added benefit for Novartis’ Jakavi in myelofibrosis

IQWiG finds added benefit for Novartis’ Jakavi in myelofibrosis

20-08-2014

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

Federal Joint CommitteeGermanyJakaviMyelofibrosisNovartisOncologyPharmaceuticalPricingRare diseasesRegulation

Australia’s NHMRC reports on progress to improve clinical trials

Australia’s NHMRC reports on progress to improve clinical trials

20-08-2014

The National Health and Medical Research Council (NHMRC), tasked with implementing a range of initiatives…

AustraliaClinical researchNational Health and Medical Research CouncilPharmaceuticalRegulationResearchTrials portal

Pfizer files palbociclib NDA with FDA for breast cancer

Pfizer files palbociclib NDA with FDA for breast cancer

19-08-2014

US pharma giant Pfizer says it has completed the submission of a New Drug Application to the US Food…

OncologypalbociclibPfizerPharmaceuticalRegulationUSA

Proposal to expand the quality control of medicines sold in Brazil

Proposal to expand the quality control of medicines sold in Brazil

18-08-2014

Brazilian House Bill 6763/13 introduced by Gorete Pereira (PR-EC) sets the standards to ensure the quality…

BrazilPharmaceuticalProductionRegulation

Eisai files for US and EU approval of lenvatinib for hard to treat thyroid cancer

Eisai files for US and EU approval of lenvatinib for hard to treat thyroid cancer

18-08-2014

Japanese pharma major Eisai has filed applications with the US Food and Drug Administration and the European…

DonepezilEisaiEuropelenvatinibOncologyPharmaceuticalRegulationUSA

IQWiG again turns down Eisai’s epilepsy drug Fycompa

IQWiG again turns down Eisai’s epilepsy drug Fycompa

17-08-2014

The German Institute for Quality and Efficiency in Healthcare (IQWiG) has said that epilepsy drug Fycompa…

EisaiEpilepsyFycompaGermanyNeurologicalPharmaceuticalPricingRegulation

Brazil plans to update the regulatory framework, expand production of medical products

Brazil plans to update the regulatory framework, expand production of medical products

15-08-2014

The Brazilian Ministry of Health has opened a public consultation to establish the criteria for product…

BrazilFederal governmentPharmaceuticalProductionRegulation

FDA FOCUS: FDA Regulations and Drug Shortages in America

FDA FOCUS: FDA Regulations and Drug Shortages in America

15-08-2014

In the first of a new monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola…

FDAFood and Drug AdministrationPharmaceuticalPharmaceutical sciencesRegulationUSA

Pfizer’s meningococcal B vaccine BLA accepted; gains priority review

Pfizer’s meningococcal B vaccine BLA accepted; gains priority review

15-08-2014

The US Food and Drug Administration has accepted for review the Biologics License Application for bivalent…

Invasive meningococcal diseaseLP2086PfizerPharmaceuticalRegulationrLP2086USAVaccines

1 to 25 of 2132 results

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