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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

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

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

FDA approves AstraZeneca’s Movantik for opioid-induced constipation

FDA approves AstraZeneca’s Movantik for opioid-induced constipation

17-09-2014

The US Food and Drug Administration yesterday approved Movantik (naloxegol), an oral treatment for opioid-induced…

AstraZenecaGastro-intestinalsMovantikNektar TherapeuticsPharmaceuticalRegulationUSA

FDA accepts Actavis NDA for eluxadoline

FDA accepts Actavis NDA for eluxadoline

03-09-2014

Ireland-headquartered generic drug major Actavis says that the US Food and Drug Administration has accepted…

ActaviseluxadolineForest LaboratoriesFuriex PharmaceuticalsGastro-intestinalsPharmaceuticalRegulationUSA

Takeda launches first gut-selective treatment for inflammatory bowel disease in the UK

Takeda launches first gut-selective treatment for inflammatory bowel disease in the UK

28-08-2014

The first gut-selective treatment for ulcerative colitis and Crohn’s Disease is now available in the…

Crohn's diseaseEntyvioGastro-intestinalsInflammatory bowel diseasePharmaceuticalRegulationTakeda PharmaceuticalUKUlcerative colitis

Insys submits Dronabinol oral solution New Drug Application

Insys submits Dronabinol oral solution New Drug Application

13-08-2014

Supportive care specialist Insys Therapeutics has made a New Drug Application submission to the US Food…

CannabinoidsDronabinolEntheogensGastro-intestinalsInsys TherapeuticsPharmaceuticalRegulationTetrahydrocannabinolUSA

NICE recommends Amitiza to treat long-term, painful constipation

NICE recommends Amitiza to treat long-term, painful constipation

23-07-2014

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Amitiza (lubiprostone)…

AmitizaGastro-intestinalsGastroenterologyPharmaceuticalRegulationSucampoUK

Astellas submits sNDA for Irribow/Irribow OD in Japan

Astellas submits sNDA for Irribow/Irribow OD in Japan

14-07-2014

Japanese drug major Astellas Pharma has submitted a supplemental New Drug Application for the indication…

Astellas PharmaGastro-intestinalsIrribowJapanPharmaceuticalRegulation

Swissmedic approves Amitiza for opioid-induced constipation

Swissmedic approves Amitiza for opioid-induced constipation

08-07-2014

US biopharma firm Sucampo Pharmaceuticals has received approval from Swissmedic, Switzerland’s Agency…

AmitizaEuropeGastro-intestinalsPharmaceuticalRegulationSucampo

UK’s NICE recommends Sucampo’s Amitiza for CIC

UK’s NICE recommends Sucampo’s Amitiza for CIC

18-06-2014

The UK health care watchdog the National Institute of Health and Care Excellence (NICE) has released…

AmitizaGastro-intestinalsPharmaceuticalPricingRegulationSucampoUK

Positive US FDA advisory panel view on PAMORAs

Positive US FDA advisory panel view on PAMORAs

13-06-2014

The majority of US Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee…

AstraZenecaGastro-intestinalsMovantiknaloxegolPharmaceuticalRegulationUSA

EU approval for Takeda’s Entyvio for UC and Crohn’s disease

27-05-2014

Takeda Pharmaceutical, Japan’s largest drugmaker has received marketing approval from the European…

EntyvioEuropeGastro-intestinalsPharmaceuticalRegulationTakeda Pharmaceutical

US FDA thumbs up for Takeda’s Entyvio for ulcerative colitis and Crohn's disease

US FDA thumbs up for Takeda’s Entyvio for ulcerative colitis and Crohn's disease

21-05-2014

The US Food and Drug Administration yesterday approved Entyvio (vedolizumab) injection, from Japan’s…

EntyvioGastro-intestinalsPharmaceuticalRegulationTakeda PharmaceuticalsUSA

Takeda gets positive CHMP opinion for Entyvio for UC and Crohn’s disease

21-03-2014

Takeda Pharmaceutical, Japan’s largest drugmaker, today received a positive opinion form the European…

EntyvioEuropeGastro-intestinalsPharmaceuticalRegulationTakeda Pharmaceuticals

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

Takeda stops development of diabetes candidate fasiglifam; PDUFA date for vedolizumab extended

Takeda stops development of diabetes candidate fasiglifam; PDUFA date for vedolizumab extended

27-12-2013

Japan’s largest drugmaker Takeda Pharmaceutical has decided voluntarily to terminate the development…

DiabetesfasiglifamGastro-intestinalsNorth AmericaPharmaceuticalRegulationResearchTakeda PharmaceuticalsUSAvedolizumab

FDA advisory panel backs approval of Takeda’s vedolizumab

FDA advisory panel backs approval of Takeda’s vedolizumab

10-12-2013

A US Food and Drug Administration advisory committee has recommended approval of vedolizumab from Japan’s…

Gastro-intestinalsPharmaceuticalRegulationTakeda PharmaceuticalsUSAvedolizumab

Health Canada clears AbbVie’s Humira for UC

Health Canada clears AbbVie’s Humira for UC

28-11-2013

In what is now the eighth indication in Canada for its top-selling drug Humira (adalimumab), US drugmaker…

AbbVieAnti-Arthritics/RheumaticsGastro-intestinalsHumiraNorth AmericaPharmaceuticalRegulation

US FDA accepts AstraZeneca’s NDA for naloxegol

US FDA accepts AstraZeneca’s NDA for naloxegol

19-11-2013

The US Food and Drug Administration has accepted the New Drug Application for naloxegol, an investigational…

AstraZenecaGastro-intestinalsnaloxegolNektar TherapeuticsNorth AmericaPharmaceuticalRegulation

US Appeals Court lifts temporary injunction on Hanmi Nexium generic NDA

03-10-2013

AstraZeneca said that the US Court of Appeals for the Federal Circuit (CAFC) lifted a temporary injunction…

AstraZenecaEsomeprazole MagnesiumGastro-intestinalsHanmi PharmaceuticalLegalNexiumNorth AmericaPharmaceuticalRegulation

AstraZeneca’s naloxegol marketing application accepted by EMA

AstraZeneca’s naloxegol marketing application accepted by EMA

27-09-2013

The European Medicines Agency has accepted AstraZeneca’s Marketing Authorization Application for naloxegol…

AstraZenecaEuropeGastro-intestinalsMarkets & MarketingnaloxegolNektar TherapeuticsPharmaceuticalRegulation

US Priority Review for Takeda's vedolizumab for ulcerative colitis

05-09-2013

Japan's largest drugmaker, Takeda Pharmaceutical (TYO: 4502) says that the US Food and Drug Administration…

Gastro-intestinalsNorth AmericaPharmaceuticalRegulationTakeda Pharmaceuticalsvedolizumab

Resubmission expected for Orexigen's obesity drug Contrave

29-08-2013

US biopharma company Orexigen Therapeutics (Nasdaq: OREX) has announced that the Light Study independent…

Arena PharmaceuticalsBelviqContraveGastro-intestinalsNorth AmericaOrexigen TherapeuticsPharmaceuticalQnexaRegulationVivus

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