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Bayer files for European approval of hemophilia A drug BAY 81-8973

06-12-2014

German pharma major Bayer has filed an application for marketing authorization to the European Medicines…

BAY 81-8973BayerEuropeHematologyPharmaceuticalRegulation

FDA advisory panel backs Actavis’ ceftazidime-avibactam

06-12-2014

Ireland-headquartered generic drugs major Actavis says that the Anti-Infective Drugs Advisory Committee…

ActavisAntibiotics and Infectious diseasesAstraZenecaceftazidime-avibactamPharmaceuticalRegulationUSA

EMA update on review of studies performed at GVK Biosciences site in Hyderabad, India

06-12-2014

Some European Union member states have decided to suspend the marketing authorizations of medicines that…

EuropeGVK BiosciencesIndiaPharmaceuticalRegulationResearch

Turning a constraint into an enabler: transparency round-table at Veeva's commercial summit 2014

Turning a constraint into an enabler: transparency round-table at Veeva's commercial summit 2014

05-12-2014

In one of the opening sessions, cloud-based life sciences provider Veeva’s co-founder and president…

BMI SystemEuropeInterviewsPharmaceuticalRegulationVeeva

Mixed findings from IQWiG on added benefit for Eliquis

05-12-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined a dossier on Eliquis…

Bristol-Myers SquibbCardio-vascularEliquisGermanyPfizerPharmaceuticalPricingRegulation

Takeda receives Breakthrough designation for ixazomib

Takeda receives Breakthrough designation for ixazomib

05-12-2014

Japanese drug major Takeda Pharmaceutical’s has been granted Breakthrough Therapy designation from…

ixazomibPharmaceuticalRare diseasesRegulationTakeda PharmaUSA

FDA grants tentative approval to Mylan's two dosages of abacavir/lamivudine tablets for pediatric HIV

FDA grants tentative approval to Mylan's two dosages of abacavir/lamivudine tablets for pediatric HIV

05-12-2014

The US Food and Drug Administration has granted tentative approval for New Drug Applications by US generic…

Abacavir Sulfate and Lamivudine TabletsAnti-viralsGenericsMylanRegulationUSA

Credit Suisse sees PTC Therapeutics as a top stock pick

05-12-2014

Credit Suisse has released a biotech research report from analysts Jason Kantor and Jeremiah Shepard…

BiotechnologyFinancialNeurologicalPTC TherapeuticsRare diseasesRegulationTranslarna

US FDA approves new indication for Incyte’s Jakafi

US FDA approves new indication for Incyte’s Jakafi

05-12-2014

The US Food and Drug Administration yesterday approved a new use for Incyte Corp’s Jakafi (ruxolitinib)…

BiotechnologyIncyteJakafiOncologyRegulationUSA

FDA guidance for prospective ANDA sponsors

FDA guidance for prospective ANDA sponsors

04-12-2014

The US Food and Drug Administration has issued new guidance in its efforts to assist in certain circumstances…

FDAGenericsPharmaceutical sciencesRegulationUSA

Added benefit of Lundbeck’s Selincro not proven, says IQWiG

04-12-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment…

GermanyLundbeckNeurologicalPharmaceuticalPricingRegulationSelincro

EMA committee concludes no evidence Fluad caused deaths

EMA committee concludes no evidence Fluad caused deaths

04-12-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that…

EuropeFluadNovartisPharmaceuticalRegulationVaccines

US FDA grants earlier approval for Amgen’s Blincyto for rare form of lymphoblastic leukemia

US FDA grants earlier approval for Amgen’s Blincyto for rare form of lymphoblastic leukemia

04-12-2014

Ahead of the anticipated decision date, the US Food and Drug Administration yesterday approved Blincyto…

AmgenBiotechnologyblinatumomabBlincytoOncologyRegulationUSA

Actelion submits selexipag for EMA marketing authorization in PAH

Actelion submits selexipag for EMA marketing authorization in PAH

03-12-2014

Swiss biotech firm Actelion has submitted a centralized Marketing Authorization Application to the European…

ActelionCardio-vascularEuropePharmaceuticalRegulationselexipag

Puma shares plummet as it delays NDA filing

Puma shares plummet as it delays NDA filing

03-12-2014

Puma Biotechnology will delay the filing of its New Drug Application (NDA) for the approval of PB272…

BiotechnologyneratinibOncologyPuma BiotechnologyRegulationUSA

FDA approves Sanofi’s Priftin for latent TB

FDA approves Sanofi’s Priftin for latent TB

03-12-2014

French pharma major Sanofi says that the US Food and Drug Administration has approved Priftin (rifapentine),…

Antibiotics and Infectious diseasesPharmaceuticalPriftinRegulationSanofiUSA

FDA accepts NDA filing from AstraZeneca for Iressa

FDA accepts NDA filing from AstraZeneca for Iressa

02-12-2014

The US Food and Drug Administration has accepted for filing the New Drug Application from Iressa (gefitinib)…

AstraZenecaIressaOncologyPharmaceuticalRegulationUK

NICE reverses October decision and approves Roche's Gazyvaro

NICE reverses October decision and approves Roche's Gazyvaro

02-12-2014

The UK’s National Institute for Health and Care Excellence (NICE) has reversed its decision on Gazyvaro…

GazyvaroOncologyPharmaceuticalRegulationRocheUK

Two batches of Novartis' Fluad taken off market for investigation in Italy after 13 deaths

Two batches of Novartis' Fluad taken off market for investigation in Italy after 13 deaths

01-12-2014

The Italian Medicines Agency (AIFA) has suspended two batches of Swiss drug major Novartis’ Fluad seasonal…

Anti-viralsFluadItalian Medicines AgencyItalyNovartisPharmaceuticalRegulation

LIF explains new rules for Danish health care professionals and Pharma relations

LIF explains new rules for Danish health care professionals and Pharma relations

01-12-2014

In Denmark, new rules took effect on Saturday, November 1 to ensure greater transparency about relations…

DenmarkLifMedicinePharmaceuticalRegulation

Janssen and Pharmacyclics submit EMA application to expand indication for Imbruvica

Janssen and Pharmacyclics submit EMA application to expand indication for Imbruvica

01-12-2014

US health care giant Johnson & Johnson’s Belgium-based subsidiary Janssen-Cilag International has submitted…

EuropeImbruvicaJanssen-CilagOncologyPharmaceuticalPharmacyclicsRegulation

Ipsen’s Dysport accepted for review by US FDA

Ipsen’s Dysport accepted for review by US FDA

28-11-2014

French drugmaker Ipsen says that the US Food and Drug Administration has accepted for review its supplemental…

DysportIpsenNeurologicalPharmaceuticalRegulationUSA

Boehringer’s Vargatef gains approval in EU for lung cancer

Boehringer’s Vargatef gains approval in EU for lung cancer

28-11-2014

The European Commission has granted EU marketing authorization for German family-owned pharma major Boehringer…

Boehringer IngelheimEuropeOncologyPharmaceuticalRegulationVargatef

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