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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

US FDA warns of hepatitis B reactivation risk with Arzerra and Rituxan

US FDA warns of hepatitis B reactivation risk with Arzerra and Rituxan

26-09-2013

The US Food and Drug Administration has approved changes to the prescribing information of the immune-suppressing…

Anti-Arthritics/RheumaticsArzerraBiogen IdecGlaxoSmithKlineNorth AmericaOncologyPharmaceuticalRegulationRituxanRoche

US FDA approves first generic Xeloda for colorectal and breast cancers

17-09-2013

The US Food and Drug Administration approved the first generic version of Swiss drug major Roche's (ROG:…

capecitabineGenericsNorth AmericaOncologyRegulationRocheTeva Pharmaceutical IndustriesXeloda

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

US FDA backs news indications for Latuda; grants Priority Review for Perjeta

02-07-2013

Sunovion Pharmaceuticals, a US subsidiary of Japan's Dainippon Sumitomo Pharma (TYO: 4506), says that…

BiotechnologyDainippon Sumitomo PharmaLatudaNeurologicalNorth AmericaOncologyPerjetaPharmaceuticalRegulationRocheSunovion

US FDA approves companion diagnostic for Tarceva, and new indication for the Roche drug

15-05-2013

The US Food and Drug Administration late yesterday (May 14) approved Swiss drug major Roche (ROG: SIX)…

Boehringer IngelheimNorth AmericaOncologyPharmaceuticalQiagenRegulationRocheTarcevaTomtovok

Regulatory updates on GSK's albiglutide, Roche's hep C test, Activartis AV0113

07-03-2013

UK pharma giant GlaxoSmithKline plc (LSE: GSK) says it has submitted a Marketing Authorization Application…

ActivartisalbiglutideAnti-viralsAV0113BiotechnologyDiabetesEperzanEuropeGlaxoSmithKlineNorth AmericaOncologyPharmaceuticalRegulationRoche

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

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

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

GlaxoSmithKline pulls sNDA for Tykerb plus Herceptin; Watson/Actavis update

13-07-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) revealed yesterday that it has withdrawn a supplemental New…

ActavisGenericsGlaxoSmithKlineHerceptinMergers & AcquisitionsNorth AmericaOncologyPharmaceuticalRegulationRocheTykerbWatson Pharmaceuticals

Fake Avastin reignites "Track-and-Trace" debate, but the clock is ticking

14-06-2012

The US Food and Drug Administration announced in February that counterfeit vials of Roche/Genentech's…

AvastinLegalNorth AmericaPharmaceuticalRegulationRoche

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

FDA approves first generics of Roche osteo drug Boniva

20-03-2012

The US Food and Drug Administration yesterday approved the first generic versions of Boniva (ibandronate)…

Anti-Arthritics/RheumaticsApotexBonivaGenericsMylan LaboratoriesNorth AmericaOrchid HealthcareRegulationRoche

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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