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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

Novartis’ heart failure drug LCZ696 granted accelerated assessment by CHMP

Novartis’ heart failure drug LCZ696 granted accelerated assessment by CHMP

28-11-2014

Swiss drug major Novartis announced that the European Medicines Agency’s Committee for Medicinal Products…

Cardio-vascularEuropeLCZ696NovartisPharmaceuticalRegulation

NICE final draft guidance recommends Soliris, but saying it is “very expensive”

NICE final draft guidance recommends Soliris, but saying it is “very expensive”

27-11-2014

The UK National Institute for Health and Care Excellence (NICE) has today issued final draft guidance…

Alexion PharmaceuticalsBiotechnologyPricingRare diseasesRegulationSolirisUK

UK uses fewer branded medicines per person than comparable countries and is still using older therapies

UK uses fewer branded medicines per person than comparable countries and is still using older therapies

27-11-2014

The Association of the British Pharmaceutical Industry has published new research showing that UK use…

ABPIMarkets & MarketingPharmaceuticalRegulationUK

FTC puts conditions on GSK/Novartis consumer JV

27-11-2014

The US Federal Trade Commission has voted to approve UK pharma giant GlaxoSmithKline’s proposed acquisition…

Dr Reddy's LaboratoriesGlaxoSmithKlineHabitrolMergers & AcquisitionsNicodermNovartisPharmaceuticalRegulationUSAVaccines

WHO's calls for more thorough clinical trial result disclosure welcomed by Germany's IQWiG

WHO's calls for more thorough clinical trial result disclosure welcomed by Germany's IQWiG

27-11-2014

The World Health Organization (WHO) has made an official statement on the disclosure of clinical trial…

GlobalHealthPharmaceuticalRegulationResearchWorld Health Organization

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