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FDA says Durect’s pain relief drug Posidur needs additional safety studies

FDA says Durect’s pain relief drug Posidur needs additional safety studies

13-02-2014

US drugmaker Durect Corp says that the US Food and Drug Administration has issued a Complete Response…

AnalgesiaDurectPharmaceuticalPosidurRegulationUSA

FDA advisory committee votes against approval of antiplatelet therapy cangrelor

FDA advisory committee votes against approval of antiplatelet therapy cangrelor

13-02-2014

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

cangrelorCardio-vascularPharmaceuticalRegulationThe Medicines CompanyUSA

FDA expands approval of Imbruvica to treat chronic lymphocytic leukemia

FDA expands approval of Imbruvica to treat chronic lymphocytic leukemia

13-02-2014

The US Food and Drug Administration yesterday expanded the approved use of US health care giant Johnson…

ImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulationUSA

Health Canada approves Celgene’s Pomalyst for multiple myeloma

Health Canada approves Celgene’s Pomalyst for multiple myeloma

12-02-2014

Regulatory agency Health Canada has approved US biotech firm Celgene’s drug Pomalyst (pomalidomide…

BiotechnologyCanadaCelgeneNorth AmericaOncologyPomalystRegulation

Sprout Pharmaceuticals to resubmit NDA for flibanserin

Sprout Pharmaceuticals to resubmit NDA for flibanserin

12-02-2014

US privately-held sexual health specialists Sprout Pharmaceuticals has received ‘clear guidance’…

flibanserinPharmaceuticalRegulationSprout PharmaceuticalsUSAWomen's Health

US FDA visit to India results in first Statement of Intent

US FDA visit to India results in first Statement of Intent

12-02-2014

A Statement of Intent has been jointly signed by officials at India’s Ministry of Health and Family…

IndiaPharmaceuticalPoliticsRegulationUSA

UK’s NICE calls for more people at risk of CVD to be prescribed statins

UK’s NICE calls for more people at risk of CVD to be prescribed statins

12-02-2014

The UK’s National Institute for Health and Care Excellence (NICE) is recommending that many more people…

Cardio-vascularHealthcarePharmaceuticalRegulationUK

FDA to review heart failure risk with AstraZeneca diabetes drug

FDA to review heart failure risk with AstraZeneca diabetes drug

12-02-2014

The US Food and Drug Administration has requested clinical trial data from Anglo-Swedish drug major AstraZeneca,…

AstraZenecaDiabetesKombiglyzeNorth AmericaOnglyzaPharmaceuticalRegulationResearchUSA

2014 to be transition year for Japan pharma

2014 to be transition year for Japan pharma

11-02-2014

2014 will be marked as a transition year for the Japanese Pharma industry – but the year is bound to…

Asia-PacificPharmaceuticalPricingRegulationResearch

India raises concerns over FDA action during visit to promote collaboration

India raises concerns over FDA action during visit to promote collaboration

11-02-2014

The US Food and Drug Administration Commissioner Margaret Hamburg has met with India’s Commerce and…

IndiaPharmaceuticalRegulationUSA

Gilead files for US approval of ledipasvir/sofosbuvir combination for hepatitis C

Gilead files for US approval of ledipasvir/sofosbuvir combination for hepatitis C

11-02-2014

US biotech major Gilead Sciences has submitted a New Drug Application (NDA) to the US Food and Drug Administration…

Antibiotics and Infectious diseasesBiotechnologyGilead SciencesledipasvirRegulationsofosbuvirUSA

Actelion gains approval in Australia for Opsumit in PAH

Actelion gains approval in Australia for Opsumit in PAH

07-02-2014

Swiss biotech firm Actelion (SIX: ATLN) has received approval of Opsumit (macitentan) for the treatment…

ActelionAustraliaBiotechnologyCardio-vascularOpsumitRegulation

New data shows FDA’s proposed generic labeling rules would add to health costs

New data shows FDA’s proposed generic labeling rules would add to health costs

06-02-2014

The US Food and Drug Administration’s Proposed Rule on prescription drug labeling would add $4 billion…

FinancialGenericsNorth AmericaRegulationUSA

US HHS strengthens patients’ right to access lab test reports

US HHS strengthens patients’ right to access lab test reports

05-02-2014

As part of an ongoing effort to empower patients to be informed partners with their health care providers,…

HealthcareNorth AmericaPharmaceuticalRegulationUSA

US health advocacy groups state case on biosimilars naming policy

04-02-2014

In advance of today's US Federal Trade Commission workshop on follow-on biologics, or biosimilars, health…

BiosimilarsGenericsNorth AmericaRegulationUSA

UK’s MHRA approves Botox for treatment of ankle disability in stroke survivors

04-02-2014

Allergan says that Botox has been approved by the UK’s Medicines and Healthcare Products Regulatory…

AllerganBotoxPharmaceuticalRegulationUK

Regulatory update on Indian clinical research approval timelines

04-02-2014

The Drug Controller General of India (DCGI) has provided written confirmation to the pharmaceutical industry…

Asia-PacificIndiaPharmaceuticalRegulationResearch

NHS England approves GSK’s Tafinlar for funding by UK’s Cancer Drugs Fund

NHS England approves GSK’s Tafinlar for funding by UK’s Cancer Drugs Fund

04-02-2014

GlaxoSmithKline’s Tafinlar (dabrafenib) is now available for metastatic melanoma patients in England…

FinancialGSKOncologyPharmaceuticalRegulationTafinlarUK

US FDA grants Edison’s EPI-743 orphan status for Friedreich's ataxia

US FDA grants Edison’s EPI-743 orphan status for Friedreich's ataxia

04-02-2014

Privately-held US pharma company Edison Pharmaceuticals has announced that the US Food and Drug Administration…

Edison PharmaceuticalsEPI-743PharmaceuticalRare diseasesRegulationUSA

UK’s NICE consults on updating guidance for Tarceva and Iressa

UK’s NICE consults on updating guidance for Tarceva and Iressa

04-02-2014

The UK’s National Institute for Health and Care Excellence (NICE) said this morning that it is reviewing…

AstraZenecadocetaxelIressaOncologyPharmaceuticalRegulationRocheTarcevaUK

US generics lobby group, GPhA, sets out 2014 priorities

US generics lobby group, GPhA, sets out 2014 priorities

04-02-2014

The US trade group the Generic Pharmaceutical Association (GPhA) has identified its key priorities for…

BiosimilarsGenericsHealthcareNorth AmericaRegulationUSA

Biogen’s MS drug Tecfidera approved in EU

Biogen’s MS drug Tecfidera approved in EU

03-02-2014

US biotech firm Biogen Idec’s Tecfidera (dimethyl fumarate) has been approved by the European Commission…

Biogen IdecBiotechnologyEuropeNeurologicalRegulationTecfidera

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