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FDA delays approval of Biogen Idec’s MS drug Plegridy

FDA delays approval of Biogen Idec’s MS drug Plegridy

18-03-2014

The US Food and Drug Administration has extended the initial Prescription Drug User Fee Act date for…

Biogen IdecBiotechnologyNeurologicalNorth AmericaPlegridyRegulationUSA

US FDA approves Pierre Fabre’s Hemangeol for infantile hemangioma

US FDA approves Pierre Fabre’s Hemangeol for infantile hemangioma

18-03-2014

Pierre Fabre Dermatologie has obtained marketing authorization from the US Food and Drug Administration…

DermatologicalsHemangeolNorth AmericaPharmaceuticalPierre FabreRegulationUSA

Australian regulator finds no definite melanoma link for natalizumab

Australian regulator finds no definite melanoma link for natalizumab

18-03-2014

Australia’s Therapeutic Goods Administration revealed today that it is monitoring reports of melanoma…

Asia-PacificAustraliaBiogen IdecBiotechnologyNatalizumabNeurologicalRegulationTysabri

Additional indication in Japan for Kyowa Hakko’s Poteligeo

Additional indication in Japan for Kyowa Hakko’s Poteligeo

18-03-2014

Japanese drugmaker Kyowa Hakko Kirin has received approval for additional indication for relapsed or…

Kyowa Hakko KirinOncologyPharmaceuticalPoteligeoRegulation

NICE draft guidance recommends Boehringer Ingelheim’s Giotrif

NICE draft guidance recommends Boehringer Ingelheim’s Giotrif

17-03-2014

UK drugs watchdog the National Institute for Health and care Excellence (NICE) this morning issued new…

Boehringer IngelheimGiotrifNorthern EuropeOncologyPharmaceuticalPricingRegulationUK

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

16-03-2014

The US Food and Drug Administration has approved pharma major Bristol-Myers Squibb’s supplemental New…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulationUSA

Undervaluing new medicines threatens patient wellbeing and economic growth; report

Undervaluing new medicines threatens patient wellbeing and economic growth; report

14-03-2014

Innovative medicines and other new therapies have extended life expectancy by some 10 years since the…

HealthcareNorthern EuropePharmaceuticalPricingRegulationUK

UK plans for early access to medicines scheme

UK plans for early access to medicines scheme

14-03-2014

Severely ill patients in the UK, and those with rare debilitating conditions, could be given new medicines…

HealthcareNorthern EuropePharmaceuticalRegulationUK

Sun Pharma latest Indian generic drugmaker to fall foul of US FDA

Sun Pharma latest Indian generic drugmaker to fall foul of US FDA

14-03-2014

Even as India-based drug majors Ranbaxy and Wockhardt reel under the impact of US Food and Drug Administration…

Asia-PacificGenericsIndiaProductionRegulation

NICE says better information needed on Celgene’s MM drug

NICE says better information needed on Celgene’s MM drug

14-03-2014

The UK drugs watchdog, the National Institute for Health and care Excellence (NICE) says that, based…

BiotechnologyCelgeneNorthern EuropeOncologyPricingRegulationRevlimidUK

Taiwan’s TaiGen Biotech receives domestic marketing approval for Taigexyn

13-03-2014

Taiwan-based drug developer TaiGen Biotechnology says that the Taiwan Food and Drug Administration has…

Antibiotics and Infectious diseasesAsia-PacificBiotechnologyRegulationTaiGen BiotechTaigexyn

Geron nosedives on FDA clinical hold for blood disorders drug imetelstat

Geron nosedives on FDA clinical hold for blood disorders drug imetelstat

12-03-2014

USA-based Geron Corp saw its shares plunge 59% to $1.79 when the company revealed that it had received…

BiotechnologyGeron CorpimetelstatNorth AmericaOncologyRegulationResearchUSA

Mallinckrodt gains FDA approval for Xartemis XR

Mallinckrodt gains FDA approval for Xartemis XR

12-03-2014

The US Food and Drug Administration has approved Ireland-headquartered specially drugmaker Mallinckrodt’s…

DepomedMallinckrodtNeurologicalNorth AmericaPharmaceuticalRegulationUSAXartemis XR

AstraZeneca’s diabetes drug Xigduo launched in UK

AstraZeneca’s diabetes drug Xigduo launched in UK

11-03-2014

Anglo-Swedish drug major AstraZeneca’s type 2 diabetes drug Xigduo is now available in the UK.

AstraZenecaDiabetesPharmaceuticalRegulationUKXigduo

Janssen’s Sirturo gets conditional EU approval for multi-resistant TB

Janssen’s Sirturo gets conditional EU approval for multi-resistant TB

10-03-2014

US health care giant Johnson & Johnson’s European subsidiary Janssen-Cilag has been granted conditional…

Antibiotics and Infectious diseasesEuropeJanssen-CilagJohnson & JohnsonPharmaceuticalRegulationSirturo

FDA accepts Lundbeck NDA for IV carbamazepine

FDA accepts Lundbeck NDA for IV carbamazepine

10-03-2014

The US subsidiary of Danish CNS specialist Lundbeck says that the Food and Drug Administration has accepted…

CarbamazepineCarbellaFinancialLigand PharmaceuticalsLundbeckNeurologicalNorth AmericaPharmaceuticalRegulationUSA

Keryx Biopharma files for EU approval of Zerenex

Keryx Biopharma files for EU approval of Zerenex

10-03-2014

US drugmaker Keryx Biopharmaceuticals has submitted a Marketing Authorization Application to the European…

EuropeKeryx BiopharmaceuticalsNephrology and HepatologyPharmaceuticalRegulationZerenex

Ranbaxy recalls Lipitor generic over dose error

Ranbaxy recalls Lipitor generic over dose error

10-03-2014

India’s largest drugmaker Ranbaxy Laboratories (BSE: 500359) has recalled more than 64,000 bottles…

Atorvastatin CalciumCardio-vascularIndiaLipitorPharmaceuticalRanbaxy LaboratoriesRegulationUSA

FDA probing Regeneron and Sanofi’s investigational drug alirocumab

FDA probing Regeneron and Sanofi’s investigational drug alirocumab

10-03-2014

French drug major Sanofi has revealed in a regulatory filing that the US Food and Drug Administration…

alirocumabCardio-vascularNorth AmericaPharmaceuticalRegeneronRegulationResearchSanofiUSA

FDA approves label changes for Doribax to reflect risks

10-03-2014

The US Food and Drug Administration has approved label changes for the antibacterial Doribax (doripenem)…

Antibiotics and Infectious diseasesDoribaxNorth AmericaPharmaceuticalRegulationShionogiUSA

Highlights from the Pharmacovigilance Risk Assessment Committee meeting

Highlights from the Pharmacovigilance Risk Assessment Committee meeting

09-03-2014

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) gave recommendations…

diacereindomperidoneEuropeGastro-intestinalsNeurologicalPharmaceuticalRegulationzolpidem

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