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AbbVie's Humira gains added indication from US FDA

AbbVie's Humira gains added indication from US FDA

25-09-2014

The US Food and Drug Administration has approved US drugmaker AbbVie’s Humira (adalimumab) for reducing…

AbbVieGastro-intestinalsHumiraInflammatory diseasesPharmaceuticalRegulationUSA

Celgene gains Swissmedic approval of Abraxane for both metastatic pancreatic and breast cancers

Celgene gains Swissmedic approval of Abraxane for both metastatic pancreatic and breast cancers

25-09-2014

Switzerland-based Celgene International, a wholly-owned subsidiary of US biotech major Celgene, say that…

AbraxaneBiotechnologyCelgene Corp.OncologyRegulationSwitzerland

FDA warning letters rise 78% over six years with increase expected in 2015

FDA warning letters rise 78% over six years with increase expected in 2015

25-09-2014

The number of warning letters sent by the US Food and Drug Administration increased substantially by…

PharmaceuticalRegulationUSA

Gilead files for Japanese approval of ledipasvir/sofosbuvir for hepatitis C

24-09-2014

Gilead Sciences has submitted a New Drug Application to Japan’s Pharmaceutical and Medical Devices…

Anti-viralsBiotechnologyGilead SciencesJapanledipasvirRegulationsofosbuvir

UK’s NICE recommends Celgene’s Revlimid for myelodysplastic syndromes

UK’s NICE recommends Celgene’s Revlimid for myelodysplastic syndromes

24-09-2014

The UK’s drug watchdog the National Institute for Health and Care Excellence (NICE) has today issued…

BiotechnologyCelgene Corp.OncologyPricingRegulationRevlimidUK

NICE opens consultation on three drugs for chronic bowel condition

NICE opens consultation on three drugs for chronic bowel condition

24-09-2014

Three drugs to treat ulcerative colitis, a chronic bowel condition, have not been proven to be more cost…

AbbVieGastro-intestinalsHumiraMerck & CoPharmaceuticalPricingRegulationRemicadeSimponi InjectionUK

FDA accepts NDA filing for Lundbeck and Otsuka's brexpiprazole

FDA accepts NDA filing for Lundbeck and Otsuka's brexpiprazole

24-09-2014

The US Food and Drug Administration has accepted the filing for review of brexiprazole for the treatment…

CNS DiseasesLundbeckOtsukaPharmaceuticalRegulationUSA

FDA fast track designation for AstraZeneca’s MEDI3902

FDA fast track designation for AstraZeneca’s MEDI3902

24-09-2014

Anglo-Swedish pharma major AstraZeneca’s global biologics R&D arm, MedImmune has received fast track…

Antibiotics and Infectious diseasesAstraZenecaBiotechnologyMEDI3902MedImmuneRegulationUSA

Celgene’s psoriasis drug Otezla gains FDA approval

Celgene’s psoriasis drug Otezla gains FDA approval

24-09-2014

The US Food and Drug Administration has approved biotech major Celgene’s Otezla (apremilast), an oral,…

BiotechnologyCelgene Corp.DermatologicalsOtezlaRegulationUSA

Despite limited size, Chile's pharma market offers growing opportunity

23-09-2014

By the end of 2014, the Chilean pharmaceutical market is expected to be worth $2 billion, increasing…

ChileHealthcareMarkets & MarketingPatentsPharmaceuticalRegulation

OxThera’s Oxabact gains orphan drug designation in EU

OxThera’s Oxabact gains orphan drug designation in EU

23-09-2014

Privately-held Swedish biopharmaceutical company OxThera AB’s product Oxabact (oxalobacter formigenes)…

EUGastro-intestinalsOxabactOxTheraPharmaceuticalRegulationSweden

IMS Health identifies 10 events that may transform the delivery of health care

IMS Health identifies 10 events that may transform the delivery of health care

23-09-2014

As the global market for drugs surpasses $1 trillion this year, growing payer scrutiny of value for money…

Anti-viralsFinancialGlobalHealthcarePharmaceuticalRegulationResearchVaccines

Amgen files BLA for BiTE immunotherapy blinatumomab

Amgen files BLA for BiTE immunotherapy blinatumomab

22-09-2014

USA-based Amgen has submitted a Biologics License Application (BLA) to the US Food and Drug Administration…

AmgenBiotechnologyblinatumomabOncologyRegulationUSA

FDA lifts clinical hold on Halozyme's PEGPH20 pancreatic cancer trial

FDA lifts clinical hold on Halozyme's PEGPH20 pancreatic cancer trial

22-09-2014

US biotech firm Halozyme Therapeutics says the US Food and Drug Administration has removed the clinical…

BiotechnologyHalozyme TherapeuticsOncologyPEGH20RegulationResearchUSA

Mitsubishi Tanabe Pharma gains approval for Telavic in genotype 2 HCV

Mitsubishi Tanabe Pharma gains approval for Telavic in genotype 2 HCV

22-09-2014

Japanese pharma company Mitsubishi Tanabe Pharma has received approval for an additional indication of…

Anti-viralsJapanMitsubishi TanabePharmaceuticalRegulationTelavic

Europe’s regulatory system for medicines can be used more effectively

Europe’s regulatory system for medicines can be used more effectively

22-09-2014

A new report from Escher, the independent TI Pharma platform for regulatory innovation, shows that the…

Andre BroekmansEuropePharmaceuticalPharmacologyRegulation

Bayer’s Eylea approved in Japan for myopic CNV

Bayer’s Eylea approved in Japan for myopic CNV

22-09-2014

Bayer Yakuhin, the Japanese health care subsidiary if Germany’s Bayer has received approval from Japan’s…

BayerEyleaJapanOphthalmicsPharmaceuticalRegeneron PharmaceuticalsRegulation

European Commission approves Gilead’s Zydelig for blood cancer

European Commission approves Gilead’s Zydelig for blood cancer

19-09-2014

The European Commission has granted marketing authorization for US biotech major Gilead Sciences’ Zydelig…

BiotechnologyEuropeGilead SciencesLymphomaMedicineOncologyRegulationZydelig

Bill to increase competition for generic drugs introduced in USA

Bill to increase competition for generic drugs introduced in USA

19-09-2014

US Representatives Steve Stivers (Republican, Ohio) Peter Welch (Democrat, Vermont) on Thursday joined…

GenericsLegalPoliticsRegulationUSA

Vivus and Auxilium’s Stendra ED drug approved as “on-demand” treatment in USA

Vivus and Auxilium’s Stendra ED drug approved as “on-demand” treatment in USA

19-09-2014

The US Food and Drug Administration has approved a supplemental New Drug Application for Stendra (avanafil),…

Auxilium PharmaceuticalsMen's HealthPharmaceuticalRegulationStendraUSAVivus

Orphan status for Navidea’s Lymphoseek in head and neck cancers

Orphan status for Navidea’s Lymphoseek in head and neck cancers

19-09-2014

US biotech company Navidea Biopharmaceuticals that its Lymphoseek (technetium Tc 99m tilmanocept) Injection…

BiotechnologyLymphoseekNavidea BiopharmaceuticalsOncologyRegulationUSA

FDA approves Lilly’s Trulicity to treat type 2 diabetes

FDA approves Lilly’s Trulicity to treat type 2 diabetes

19-09-2014

The US Food and Drug Administration yesterday approved pharma major Eli Lilly’s Trulicity (dulaglutide),…

BydureonDiabetesdulaglutideEli LillyPharmaceuticalRegulationTanzeumTrulicityUSAVictoza

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