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Roche’s Gazyva gains FDA approval of CLL

Roche’s Gazyva gains FDA approval of CLL

04-11-2013

The US Food and Drug Administration late Friday approved Roche’s Gazyva (obinutuzumab), also known…

Biogen IdecBiotechnologyGazyvaGenentechMabTheraNorth AmericaobinutuzumabOncologyRegulationRituxanRoche

Genentech’s SC Actemra approved by US FDA for severe RA

Genentech’s SC Actemra approved by US FDA for severe RA

22-10-2013

Genentech has announced that the US Food and Drug Administration has approved a subcutaneous formulation…

ActemraAnti-Arthritics/RheumaticsGenentechNorth AmericaPharmaceuticalRegulationRoche

FDA advisory panel backs new indication for Genentech's Perjeta

13-09-2013

The US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) yesterday (September…

BiotechnologyGenentechKadcylaNorth AmericaOncologyPerjetaPharmaceuticalRegulationRoche

Conditional EU approval for Roche basal cell carcinoma drug

15-07-2013

The European Commission has granted conditional approval to Swiss drug major Roche's (ROG: SIX) Erivedge…

BiotechnologyCurisErivedgeEuropeGenentechOncologyPharmaceuticalRegulationRoche

Genentech Ph III study of omalizumab shows promise in CIU

25-02-2013

Genentech, the US biotech subsidiary of Swiss drug major Roche (ROG: SIX), announced results from a Phase…

BiotechnologyDermatologicalsGenentechNovartisOmalizumabPharmaceuticalRegulationResearchRespiratory and PulmonaryRocheXolair

US FDA approves Roche's late-stage breast cancer drug Kadcyla

25-02-2013

The US Food and Drug Administration on Friday approved Kadcyla (ado-trastuzumab emtansine), a new therapy…

BiotechnologyGenentechImmunoGenKadcylaNorth AmericaOncologyPharmaceuticalRegulationRochetrastuzumab emtansine

US biotech giants lobbying to block biosimilars, NTY claims

31-01-2013

Some of the USA's biggest biotechnology companies are lobbying intensively to limit generic competition…

AmgenBiotechnologyGenentechGenericsNorth AmericaPoliticsRegulation

FDA clears new use for Roche's Avastin and Novartis' Exjade

25-01-2013

The US Food and Drug Administration has approved a new use for Swiss drug major Roche's (ROG: SIX) US…

AvastinBiotechnologyExjadeGenentechNorth AmericaNovartisOncologyPharmaceuticalRegulationRoche

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

Genentech's T-DM1 significantly improved survival for metastatic breast cancer patients

29-08-2012

Swiss drug major Roche (ROG: SIX) US subsidiary Genentech has announced updated results from the Phase…

BiotechnologyGenentechOncologyPharmaceuticalRegulationResearchRocheT-DM1trastuzumab emtansine

Roche gains FDA approval for Lucentis in diabetic macular edema

13-08-2012

US biotech firm Genentech, a subsidiary of Swiss drug major Roche (ROG: SIX) announced on Friday that…

GenentechLucentisNorth AmericaOphthalmicsPharmaceuticalRegulationRoche

Genentech gains FDA panel backing for Lucentis to treat DME

30-07-2012

US biotech firm Genentech, a subsidiary of Swiss drug major Roche (ROG: SIX), revealed last week that…

BiotechnologyGenentechLucentisNorth AmericaOphthalmicsPharmaceuticalRegulationRoche

FDA backs Roche's personalized breast cancer therapy Perjeta

11-06-2012

The US Food and Drug Administration on Friday approved Swiss drug major Roche (ROG: SIX) subsidiary Genentech's…

BiotechnologyGenentechNorth AmericaOncologyPerjetapertuzumabPharmaceuticalRegulationRoche

Roche to file for trastuzumab emtansine this year, on positive Ph III results

03-04-2012

Swiss drug major Roche (ROG: SIX) says that top-line results of EMILIA, the first randomized Phase III…

BiotechnologyGenentechGlaxoSmithKlineOncologyPharmaceuticalRegulationResearchRochetrastuzumab

Counterfeit Avastin found in USA by FDA

16-02-2012

The US Food and Drug Administration said yesterday that it is warning health care professionals and patients…

AvastinGenentechMarkets & MarketingNorth AmericaOncologyPharmaceuticalRegulationRoche

Faster-than-expected FDA approval of Roche’s vismodegib

31-01-2012

There was good news for Swiss drug major Roche's (ROG: SIX)subsidiary Genentech yesterday, when it received…

BiotechnologyCurisErivedgeGenentechNorth AmericaOncologyPharmaceuticalRegulationRochevismodegib

Roche unit in partial patent deal with Regeneron over Eylea; new indication for Avastin

04-01-2012

Regeneron Pharmaceuticals (Nasdaq: REGN) says it has entered into a non-exclusive license and partial…

AvastinBiotechnologyEuropeEyleaGenentechLegalNorth AmericaOncologyOphthalmicsPatentsPharmaceuticalRegeneronRegulationRoche

US FDA revokes Roche/Genentech Avastin license for metastatic breast cancer

21-11-2011

After months of deliberations, the US Food and Drug Administration (FDA Commissioner is revoking the…

AvastinBiotechnologyGenentechNorth AmericaOncologyPharmaceuticalRegulationRoche

FDA priority review for Roche/Genentech’s vismodegib for skin cancer

10-11-2011

The US Food and Drug Administration has accepted and filed Swiss drug major Roche (ROG: SIX) subsidiary…

BiotechnologyCurisGenentechNorth AmericaOncologyPharmaceuticalRegulationRochevismodegib

Genentech files with US FDA for vismodegib in rare form of advanced skin cancer

13-09-2011

In a second filing for a novel skin cancer drug this year, Swiss drug major Roche (ROG: SIX) US subsidiary…

BiotechnologyCurisGenentechNorth AmericaOncologyPharmaceuticalRegulationRochevismodegib

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