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Positive WHO assessment of China’s vaccines regulatory authority

Positive WHO assessment of China’s vaccines regulatory authority

06-07-2014

China's national vaccine supervision system has met or passed all the standard requirements of the World…

ChinaPharmaceuticalRegulationVaccines

GSK receives EU approval for Mekinist for melanoma

GSK receives EU approval for Mekinist for melanoma

04-07-2014

The European Commission has granted marketing authorization for UK pharma giant GlaxoSmithKline’s Mekinist…

EuropeGlaxoSmithKlineMekinistOncologyPharmaceuticalRegulation

Japan first to approve Roche’s lung cancer drug alectinib

Japan first to approve Roche’s lung cancer drug alectinib

04-07-2014

The Japanese Ministry of Health, Labor and Welfare has approved Swiss pharma major Roche’s alectinib…

alectinibJapanOncologyPharmaceuticalRegulationRoche

Brazil’s ANVISA opens public consultation on bioavailability/bioequivalence of medicines

Brazil’s ANVISA opens public consultation on bioavailability/bioequivalence of medicines

04-07-2014

The Brazilian National Health Surveillance Agency, ANVISA, has initiated a public consultation to review…

BrazilPharmaceuticalRegulation

EMA/CHMP positive opinion for Teva’s Seasonique contraceptive

EMA/CHMP positive opinion for Teva’s Seasonique contraceptive

04-07-2014

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive…

EuropePharmaceuticalRegulationReproductiveSeasoniqueTeva Pharmaceutical IndustriesWomen's Health

FDA approves Spectrum’s Beleodaq for PTCL

FDA approves Spectrum’s Beleodaq for PTCL

04-07-2014

Under its accelerated approval program, the US Food and Drug Administration late yesterday cleared Spectrum…

BeleodaqbelinostatOncologyPharmaceuticalRegulationSpectrum PharmaceuticalsTopotargetUSA

EU approval for GSK and Genmab’s Arzerra as first-line CLL therapy

EU approval for GSK and Genmab’s Arzerra as first-line CLL therapy

03-07-2014

The European Commission has granted marketing authorization for a new indication for the use of UK pharma…

ArzerraEuropeGenmabGlaxoSmithKlineOncologyPharmaceuticalRegulation

Teva files citizen petition with FDA regarding Copaxone complexity

Teva files citizen petition with FDA regarding Copaxone complexity

03-07-2014

Teva Pharmaceutical Industries says it has filed a citizen petition regarding the approvability of purported…

CopaxoneLegalNeurologicalPatentsPharmaceuticalRegulationTeva Pharmaceutical IndustriesUSA

Eisai’s breast cancer drug Halaven receives MAA in Europe

Eisai’s breast cancer drug Halaven receives MAA in Europe

03-07-2014

The European Commission has issued Marketing Authorization Approval (MAA) for Halaven (eribulin) from…

EisaiEuropeHalavenOncologyPharmaceuticalRegulation

FDA orphan status for Insys’ cannabidiol as treatment for Dravet syndrome

FDA orphan status for Insys’ cannabidiol as treatment for Dravet syndrome

03-07-2014

US specialty pharma firm Insys Therapeutics yesterday revealed that the US Food and Drug Administration…

cannabidiolInsys TherapeuticsNeurologicalPharmaceuticalRare diseasesRegulationUSA

FDA accepts Boehringer’s nintedanib NDA; granted priority review for IPF

FDA accepts Boehringer’s nintedanib NDA; granted priority review for IPF

02-07-2014

The US subsidiary of German family-owned drug major Boehringer Ingelheim says that the New Drug Application…

Boehringer IngelheimnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

USA’s GPhA and numerous other groups lodge concerns on biosimilars names

USA’s GPhA and numerous other groups lodge concerns on biosimilars names

02-07-2014

A total of 32 organizations have signed a letter calling on the US Food and Drug Administration to require…

BiosimilarsBiotechnologyRegulationUSA

Pozen re-files for US approval of PA8140/PA32540

Pozen re-files for US approval of PA8140/PA32540

02-07-2014

US drug firm Pozen has resubmitted the New Drug Application for PA8140/PA32540 (aspirin and omeprazole)…

AspirinCardio-vascularOmeprazolePA8140/PA32540PharmaceuticalPozenRegulationUSA

US FDA outlines expectations for human drug compounders

US FDA outlines expectations for human drug compounders

02-07-2014

Yesterday, the US Food and Drug Administration issued several policy documents regarding compounded drug…

PharmaceuticalRegulationUSA

Thrombogenics’ Jetrea gains first Latin American approval in Uruguay

Thrombogenics’ Jetrea gains first Latin American approval in Uruguay

02-07-2014

Belgium-based biopharma firm ThromboGenics has said that Jetrea (ocriplasmin) has been approved in Uruguay…

JetreaOphthalmicsPharmaceuticalRegulationThromboGenicsUruguay

Medicines Australia submits new transparency reforms to ACCC

Medicines Australia submits new transparency reforms to ACCC

02-07-2014

Trade body Medicines Australia has applied for authorization of the 18th Edition of its Code of Conduct…

AustraliaPharmaceuticalRegulation

South Africa regulator gives MSF access to cheaper TB drug linezolid

South Africa regulator gives MSF access to cheaper TB drug linezolid

01-07-2014

After a three-year long struggle, humanitarian aid agency Medecins Sans Frontieres has received approval…

Antibiotics and Infectious diseasesGenericsHealthcareLinezolidPfizerRegulationSouth AfricaZyvox

Breakthrough status for Amgen’s blinatumomab in ALL

01-07-2014

USA-based Amgen, the world's largest independent biotech firm, says that the US Food and Drug Administration…

AmgenBiotechnologyblinatumomabOncologyRegulationUSA

Ipsen files sNDA for Somatuline for GEP-NETs

Ipsen files sNDA for Somatuline for GEP-NETs

01-07-2014

French drugmaker Ipsen has submitted a Supplemental New Drug Application to the US Food and Drug Administration…

IpsenOncologyPharmaceuticalRegulationSomatulineUSA

pSivida’s marketing authorizations for Iluvien in 10 countries reaches next stage

pSivida’s marketing authorizations for Iluvien in 10 countries reaches next stage

01-07-2014

Drug delivery specialists pSivida says that the regulatory process for marketing authorizations of Iluvien…

EuropeIluvienOphthalmicsPharmaceuticalpSividaRegulation

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