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Unanimous FDA panel support for Merck & Co’s Grastek

Unanimous FDA panel support for Merck & Co’s Grastek

13-12-2013

The Allergenic Products Advisory Committee (APAC) of the US Food and Drug Administration yesterday voted…

Alk-AbelloGrastekGrazaxImmunologicalsMerck & CoNorth AmericaPharmaceuticalRegulation

Orexigen has another go at FDA approval of obesity drug Contrave

Orexigen has another go at FDA approval of obesity drug Contrave

12-12-2013

US biopharma company Orexigen Therapeutics is having another stab at gaining approved for its weight-loss…

ContraveMetabolicsNorth AmericaOrexigen TherapeuticsPharmaceuticalRegulation

FTC approves final order regarding Actavis’ acquisition of Warner Chilcott

FTC approves final order regarding Actavis’ acquisition of Warner Chilcott

12-12-2013

Following a public comment period, the US Federal Trade Commission has approved a final order settling…

ActavisGenericsMergers & AcquisitionsNorth AmericaRegulationReproductiveWarner Chilcott

6% annual growth forecast for NSCLC market in major Latin America countries

6% annual growth forecast for NSCLC market in major Latin America countries

12-12-2013

From 2013 to 2018, the non-small-cell lung cancer (NSCLC) market in Argentina, Brazil and Mexico will…

ArgentinaBrazilMarkets & MarketingOncologyPharmaceuticalSouth America

CytRx rockets on strong new data for sarcoma drug aldoxorubicin

CytRx rockets on strong new data for sarcoma drug aldoxorubicin

12-12-2013

The release of much anticipated new data by US biotech firm CytRx Corp on its investigation drug aldoxorubicin…

aldoxorubicinBiotechnologyCytRxOncologyResearch

Stallergenes' Oralair gains US FDA panel backing

Stallergenes' Oralair gains US FDA panel backing

12-12-2013

France’s Stallergenes said late yesterday that the Allergenic Products Advisory Committee (APAC) of…

GREER LaboratoriesImmunologicalsNorth AmericaOralairPharmaceuticalRegulationStallergenes

Agios extends cancer metabolism accord with Celgene

Agios extends cancer metabolism accord with Celgene

12-12-2013

Metabolism specialist Agios Pharmaceuticals has announced an extension of one additional year to the…

Agios PharmaceuticalsBiotechnologyCelgeneLicensingOncologyResearch

ALK and Merck Co’s grass allergy tablet finally reaches FDA committee

ALK and Merck Co’s grass allergy tablet finally reaches FDA committee

10-12-2013

The US Food and Drug Administration Allergenic Products Advisory Committee will review US pharma giant…

ALK AbelloImmunologicalsMerck & CoPharmaceuticalRegulationUSA

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

Advaxis rockets on out-licensing ADXS-HPV in Asia

09-12-2013

Shares of US cancer drug developer Advaxis leapt 22% to $4.38 in pre-market trading as the company revealed…

AdvaxisADXS-HPVBiotechnologyGlobal BioPharmaLicensingMergers & AcquisitionsOncologyTaiwan Biotech

Catalyst-rich period ahead for key trial results from BioLineRx

09-12-2013

Israeli drug developer BioLineRx is entering a catalyst-rich phase over the next 12 months, which will…

Anti-viralsBioLineRxBL-1040BL-8020BL-8040Cardio-vascularFinancialOncologyPharmaceuticalResearch

Newron and Zambon file for EU approval of Parkinson’s drug safinamide

09-12-2013

Italian drug developer Newron Pharmaceuticals and its partner, family-owned Italian drugmaker Zambon…

EuropeNeurologicalNewron PharmaNorth AmericaPharmaceuticalRegulationsafinamideZambon

Oxford BioTherapeutics and Menarini progress enhanced antibody for acute myeloid leukemia

09-12-2013

UK-based Oxford BioTherapeutics and Berlin-Chemie, a subsidiary of family-owned Italian drugmaker Menarini,…

BiotechnologyEuropeMenariniOncologyOxford BioTherapeuticsResearch

IQWiG finds hint of added benefit for Xtandi in prostate cancer

IQWiG finds hint of added benefit for Xtandi in prostate cancer

09-12-2013

In an early benefit assessment under the Act on the German Reform of the Market for Medicinal Products…

Astellas PharmaEuropeMedivationOncologyPharmaceuticalPricingRegulationXtandi

Revised clinical practice guidelines for management of hepatitis C virus infection from EASL

09-12-2013

The European Association for the Study of the Liver has today published its revised Clinical Practice…

Anti-viralsEuropePharmaceuticalRegulation

New Code of Practice for Cyprus pharma group KEFEA

09-12-2013

Stricter provisions on the promotion of prescription medicines to health care professionals are among…

EuropeMarkets & MarketingPharmaceuticalRegulation

New Zealand funding plans for Tarceva and Revolade

New Zealand funding plans for Tarceva and Revolade

09-12-2013

Following a consultation, New Zealand’s Pharmaceutical Management Agency PHARMAC said this morning…

Asia-PacificGlaxoSmithKlineHematologyNew ZealandOncologyPharmaceuticalPricingRegulationRevoladeRocheTarceva

Benefits of Kogenate/Helixate NexGen outweigh risks, says EMA unit

Benefits of Kogenate/Helixate NexGen outweigh risks, says EMA unit

08-12-2013

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the…

BayerCardio-vascularCSL BehringCSL LimitedEuropeHelixateHematologyKogenatePharmaceuticalRegulation

Sanofi’s Aubagio gains backing from UK’s NICE

Sanofi’s Aubagio gains backing from UK’s NICE

08-12-2013

In final draft guidance issued on Friday, the UK drugs watchdog the National Institute for Health and…

AubagioEuropeGenzymeNeurologicalPharmaceuticalPricingRegulationSanofiUK

US FDA approval for Gilead's hepatitis C drug Sovaldi

US FDA approval for Gilead's hepatitis C drug Sovaldi

08-12-2013

US antiviral biotech specialist Gilead Sciences says that the Food and Drug Administration has approved…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPricingRegulationsofosbuvirSovaldi

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