Regulation - Celgene

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FTC amicus brief: Improper use of restricted drug distribution programs may impede generic competition

FTC amicus brief: Improper use of restricted drug distribution programs may impede generic competition

20-06-2014

The US Federal Trade Commission has filed an amicus brief in the New Jersey US District Court explaining…

CelgeneGenericsLegalMylanPharmaceuticalRegulationUSA

Celgene exercises option for Agios Pharma’s AG-221

Celgene exercises option for Agios Pharma’s AG-221

17-06-2014

Metabolism specialist Agios Pharmaceuticals says that its partner, biotech major Celgene Corp, has exercised…

AG-221Agios PharmaceuticalsBiotechnologyCelgeneLicensingOncologyRegulationResearchUSA

NICE draft guidance negative on Celgene’s Revlimid

20-05-2014

UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) has today issued…

BiotechnologyCelgeneOncologyPricingRegulationRevlimidUK

Celgene’s Otezla is first oral therapy OKed by FDA for adults with active psoriatic arthritis

23-03-2014

The US Food and Drug Administration on Friday approved US biotech firm Celgene’s Otezla (apremilast),…

Anti-Arthritics/RheumaticsapremilastBiotechnologyCelgeneNorth AmericaOtezlaRegulationUSA

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

Health Canada approves Celgene’s Pomalyst for multiple myeloma

Health Canada approves Celgene’s Pomalyst for multiple myeloma

12-02-2014

Regulatory agency Health Canada has approved US biotech firm Celgene’s drug Pomalyst (pomalidomide…

BiotechnologyCanadaCelgeneNorth AmericaOncologyPomalystRegulation

Celgene’s Abraxane given European approval for pancreatic cancer

Celgene’s Abraxane given European approval for pancreatic cancer

07-01-2014

US biotech company Celgene’s European subsidiary today announced that the European Commission has granted…

AbraxaneCelgeneEuropeOncologyPharmaceuticalRegulation

Celgene’s Abraxane gets positive CHMP opinion for pancreatic cancer

Celgene’s Abraxane gets positive CHMP opinion for pancreatic cancer

29-11-2013

US biotech company Celgene’s (Nasdaq: CELG) European subsidiary has received a positive opinion from…

AbraxaneCelgeneEuropeOncologyPharmaceuticalRegulation

Negative draft NICE guidance on Celgene’s Revlimid for myelodysplastic syndromes

24-10-2013

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

BiotechnologyCelgeneEuropeOncologyRegulationRevlimid

US FDA backs Abraxane for metastatic pancreatic cancer

09-09-2013

US biotech firm Celgene (Nasdaq: CELG) said on Friday (September 6) that the US Food and Drug Administration…

AbraxaneBiotechnologyCelgenegemcitabine HclNorth AmericaOncologyRegulation

Epizyme's leukemia compound granted orphan drug designation

19-08-2013

US biotech company Epizyme (NASDAQ: EPZM) has been granted orphan drug designation for its experimental…

BiotechnologyCelgeneEpizymeNorth AmericaOncologyRegulation

Pomalidomide Celgene OKed in Europe

09-08-2013

The European Commission has granted approval for US biotech firm Celgene's (Nasdaq: CELG) Pomalidomide…

BiotechnologyCelgeneEuropeImnovidOncologypomalidomidePomalidomide CelgeneRegulation

Celgene gets negative NICE view on Revlimid in rare blood cancer; presents new data in newly-diagnosed MM

11-07-2013

US biotech firm Celgene (Nasdaq: CELG) today (July 11) expressed disappointment at the preliminary decision…

BiotechnologyCelgeneEuropeOncologyPricingRare diseasesRegulationResearchRevlimid

US FDA backs new indication for Celgene's Revlimid

06-06-2013

The US Food and Drug Administration has approved US biotech firm Celgene's (Nasdaq: CELG) supplemental…

BiotechnologyCelgeneNorth AmericaOncologyRegulationRevlimid

Chelsea Thera to re-file Northera NDA with existing data; Celgene share buyback

21-02-2013

Chelsea Therapeutics International (Nasdaq: CHTP) saw its shares more than double to $1.61 in pre-market…

BiotechnologyCardio-vascularCelgeneChelsea TherapeuticsFinancialNorth AmericaNortheraRegulation

Celgene's Revlimid approved in China for MM; gets PDUFA date in USA for mantle cell lymphoma

12-02-2013

Celgene Corp's (Nasdaq: CELG) European subsidiary revealed that Revlimid (lenalidomide) has been granted…

Asia-PacificBiotechnologyCelgeneNorth AmericaOncologyRegulationRevlimid

FDA approves Celgene's Pomalyst for advanced multiple myeloma

11-02-2013

The US Food and Drug Administration on Friday approved biotech firm Celgene's (Nasdaq: CELG) Pomalyst…

BiotechnologyCelgeneNorth AmericaOncologypomalidomidePomalystRegulation

Positive CHMP recommendations for Sanofi and Novartis, but not for Celgene

19-11-2012

There was a batch of good news for two pharma companies and a negative opinion for one last Friday coming…

BexseroBiotechnologyCelgeneDiabetesEuropeIstodaxLyxumiaNovartisOncologyPharmaceuticalRegulationSanofiVaccinesZaltrap

FDA Approves Abraxane for NSCLC and expands indication for Actemra

15-10-2012

The US Food and Drug Administration on Friday approved biotech firm Celgene's (Nasdaq: CELG) Abraxane…

AbraxaneActemraAnti-Arthritics/RheumaticsBiotechnologyCelgeneGenentechNorth AmericaOncologyPharmaceuticalRegulationRoche

Regulatory briefs: Celgene's pomalidomide; Lundbeck's vortioxetine

21-09-2012

US biotech firm Celgene (Nasdaq: CELG) says that the US Food and Drug Administration's Oncologic Drugs…

Asia-PacificBiotechnologyCelgeneLundbeckNeurologicalNorth AmericaOncologyPharmaceuticalpomalidomideRegulationvortioxetine

Celgene slumps as it pulls new EU indication filing for Revlimid

22-06-2012

Celgene International, the European subsidiary of USA-based Celgene Corp (Nasdaq: CELG), has provided…

BiotechnologyCelgeneEuropeFinancialOncologyPharmaceuticalpomalidomideRegulationRevlimid

1 to 25 of 29 results

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