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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

Takeda files for diabetes drug trelagliptin succinate approval in Japan

Takeda files for diabetes drug trelagliptin succinate approval in Japan

09-03-2014

Takeda Pharmaceutical, Japan’s largest drugmaker, has submitted a New Drug Application to the Japanese…

Asia-PacificBlopressCardio-vascularDiabetesJapanPharmaceuticalRegulationResearchTakeda Pharmaceuticalstrelagliptin

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

Ph III study for Jakavi meets endpoint in patients with polycythemia vera

Ph III study for Jakavi meets endpoint in patients with polycythemia vera

07-03-2014

Swiss pharma major Novartis today announced positive results from a pivotal Phase III trial of Jakavi…

IncyteJakaviNovartisOncologyPharmaceuticalRare diseasesRegulationResearch

Streamlined PBS pricing processes to improve access to medicines in Australia

Streamlined PBS pricing processes to improve access to medicines in Australia

07-03-2014

From April 1, the Australian government will implement a new streamlined process to reduce the time taken…

Asia-PacificAustraliaPharmaceuticalPricingRegulation

Endo’s testosterone replacement Aveed gets FDA approval

Endo’s testosterone replacement Aveed gets FDA approval

06-03-2014

Endo International says its operating company Endo Pharmaceuticals has received US Food and Drug Administration…

AveedEndo PharmaceuticalsMen's HealthNorth AmericaPharmaceuticalRegulationUSA

Boehringer Ingelheim presents new data for HCV/HIV candidate faldaprevir

Boehringer Ingelheim presents new data for HCV/HIV candidate faldaprevir

06-03-2014

German family-owned pharma major Boehringer Ingelheim announced positive results from STARTVerso 4 in…

Anti-viralsBoehringer IngelheimfaldaprevirPharmaceuticalRegulationResearch

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

05-03-2014

There was disappointment today for US drug major Eli Lilly and family-owned German pharma firm Boehringer…

Boehringer IngelheimDiabetesEli LillyempagliflozinNorth AmericaPharmaceuticalProductionRegulationUSA

Titan Pharma in general agreement with FDA on pathway for Probuphine

Titan Pharma in general agreement with FDA on pathway for Probuphine

04-03-2014

California, USA-based Titan Pharma and its partner, Braeburn Pharmaceuticals, have agreed in principle…

Braeburn PharmaceuticalsNeurologicalNorth AmericaPharmaceuticalProbuphineRegulationResearchTitan PharmaceuticalsUSA

RedHill Biopharma and IntelGenx respond to CRL on rizatriptan

04-03-2014

Emerging Israeli biotech firm RedHill Biopharma, together with Canadian drug delivery specialist IntelGenx,…

BiotechnologyIntelGenxNeurologicalNorth AmericaRedHill BiopharmaRegulationUSA

Teva gains approval for generic Evista in the USA

Teva gains approval for generic Evista in the USA

04-03-2014

Israel-based Teva Pharmaceutical Industries says it has received approval from the US Food and Drug Administration…

Anti-Arthritics/RheumaticsEli LillyEvistaGenericsNorth AmericaRegulationTeva Pharmaceutical IndustriesUSA

France’s AAA makes acquisition, gains orphan status for Gallium-68 DOTATATE

04-03-2014

French molecular nuclear medicines specialist Advanced Accelerator Applications SA (AAA) has acquired…

Advanced Accelerator ApplicationsGallium-68 DOTATATEMergers & AcquisitionsPharmaceuticalRegulation

UK’s NICE does U-turn on Pfizer’s Inlyta for advanced kidney cancer

UK’s NICE does U-turn on Pfizer’s Inlyta for advanced kidney cancer

04-03-2014

UK drug watchdog the National Institute for Health and Care Excellence (NICE) this morning published…

InlytaNorthern EuropeOncologyPharmaceuticalPricingRegulationRocheUK

FDA approves Bydureon Pen for type 2 diabetes

FDA approves Bydureon Pen for type 2 diabetes

03-03-2014

Anglo-Swedish drug major AstraZeneca says the US Food and Drug Administration has approved the Bydureon…

AlkermesAmylinAstraZenecaBristol-Myers SquibbBydureonDiabetesPharmaceuticalRegulationUSA

Bayer submits marketing authorization for Eylea in Japan

Bayer submits marketing authorization for Eylea in Japan

03-03-2014

US biotech firm Regeneron Pharmaceuticals and partner Bayer’s Japanese subsidiary Bayer Yakuhin have…

BayerEyleaJapanOphthalmicsPharmaceuticalRegeneronRegulation

GSK files for US approval for Promacta for severe aplastic anemia

GSK files for US approval for Promacta for severe aplastic anemia

02-03-2014

UK pharma giant GlaxoSmithKline has submitted a supplemental New Drug Application to the US Food and…

GlaxoSmithKlineLigand PharmaceuticalsNorth AmericaOncologyPharmaceuticalPromactaRare diseasesRegulationUSA

Actavis challenges Multaq and Colcrys patents

02-03-2014

Ireland-headquartered generic drugmaker Actavis revealed on Friday (February 28) that French pharma giant…

ActavisAnti-Arthritics/RheumaticsCardio-vascularColcrysGenericsLegalMultaqNorth AmericaPatents & Trade marksRegulationSanofiTakeda PharmaceuticalsUSA

US orphan status for GW Pharma’s Epidiolex in Lennox-Gastaut syndrome

28-02-2014

UK-based GW Pharmaceuticals says that the Food and Drug Administration has granted orphan drug designation…

epidiolexGW PharmaceuticalsNeurologicalNorth AmericaPharmaceuticalRegulationUSA

Negative NICE appraisal for Eli Lilly’s Alimta as maintenance therapy

27-02-2014

UK health care guidance body the National Institute for Health and Care Excellence (NICE) has published…

AlimtaEli LillyNorthern EuropeOncologyPharmaceuticalPricingRegulationUK

BIO urges Indiana Governor to sign Bill on interchangeable biologic medicines

27-02-2014

US trade group the Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF)…

BiosimilarsGenericsLegalNorth AmericaRegulationUSA

“Overwhelming approval” in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

“Overwhelming approval” in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

27-02-2014

Despite citing the need for further safety studies, both US and EU regulators have lauded the immunogenicity…

Anti-viralsBiotechnologyDynavax TechnologiesHeplisavRegulationResearchVaccines

Cell Thera’s NHL drug Pixuvri gets backing from UK’s NICE

27-02-2014

US biotech firm Cell Therapeutics has received positive news from the UK’s drugs watchdog for use of…

BiotechnologyCell TherapeuticsNorthern EuropeOncologyPixuvriPricingRegulationUK

UK’s NICE gives green light to Bayer’s Eylea in final guidance

26-02-2014

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has published final guidance…

BayerEyleaNorthern EuropeOphthalmicsPharmaceuticalPricingRegulationUK

US FDA approves Anika’s Monovisc for osteoarthritis pain of the knee

26-02-2014

US drugmaker Anika Therapeutics has received marketing approval for Monovisc from the US Food and Drug…

Anika TherapeuticsAnti-Arthritics/RheumaticsDePuyMonoviscNorth AmericaPharmaceuticalRegulationUSA

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