Regulation - Roche

Filter

Current filters:

Roche

Popular Filters

51 to 75 of 135 results

IQWiG says no added benefit for Roche’s Erivedge has been proven

IQWiG says no added benefit for Roche’s Erivedge has been proven

18-11-2013

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products…

ErivedgeEuropeOncologyPharmaceuticalPricingRegulationRoche

Report: Tarceva and Iressa favored by European oncologists for NSCLC

Report: Tarceva and Iressa favored by European oncologists for NSCLC

04-11-2013

Oncologists across the top five European countries are prescribing Roche's Tarceva or AstraZeneca's Iressa…

AstraZenecaEuropeIressaOncologyPfizerPharmaceuticalPricingRegulationRocheTarcevaXalkori

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

UK NICE final draft guidance on treatment for chronic hepatitis C

UK NICE final draft guidance on treatment for chronic hepatitis C

11-10-2013

The UK drugs watchdog the National Institute of Health and Care Excellence this morning confirmed its…

Anti-viralsEuropeMerck & CoPegasysPharmaceuticalPricingRegulationRocheViraferon

UK’s NICE thumbs up for Roche drug in rare autoimmune disease in draft guidance

UK’s NICE thumbs up for Roche drug in rare autoimmune disease in draft guidance

03-10-2013

The UK’s drugs watchdog, the National Institute for Health and Care Excellence (NICE) has published…

EuropeMabTheraOncologyPharmaceuticalPricingRegulationRoche

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

CHMP positive decision for Kadcyla, and approval in Japan

20-09-2013

The cancer drug Kadcyla (trastuzumab emtansine) has today received a positive opinion from the European…

Asia-PacificEuropeImmunoGenKadcylaOncologyPharmaceuticalRegulationRoche

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

Roche's new timesaving formulation of Herceptin approved in Europe

02-09-2013

Swiss pharma major Roche (ROG: SIX) revealed this morning (September 2) that a new injectable (subcutaneous)…

BiotechnologyEuropeHerceptinOncologyPharmaceuticalRegulationRoche

UK NICE guidance says breast cancer drug Perjeta not value for money

06-08-2013

The UK's National Health Service (NHS) is to be advised that it should not routinely provide Swiss drug…

BiotechnologyEuropeOncologyPerjetaPharmaceuticalPricingRegulationRoche

UK's NICE calls for more data to consider Roche drug for a type of vasculitis

23-07-2013

UK drug watchdog the National Institute for Health and Care Excellence (NICE) has today (July 23) published…

BiotechnologyEuropeMabTheraOncologyPharmaceuticalPricingRare diseasesRegulationRoche

New Zealand consults on Victrelis listing and some Pegasys amendments

19-07-2013

New Zealand's Pharmaceutical Management Agency, PHARMAC, is seeking feedback on a proposal to list boceprevir…

Anti-viralsAsia-PacificBiotechnologyMerck & CoPegasysPharmaceuticalRegulationRocheVictrelis

UK's NICE recommends hepatitis C treatment for children

18-07-2013

In draft guidance published this week, the UK's drugs watchdog the National Institute for Health and…

Anti-viralsBiotechnologyEuropeMerck & CoPegasysPharmaceuticalPricingRegulationRocheViraferonPeg

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

Roche granted FDA Priority Review for obinutuzumab in the treatment of chronic lymphocytic leukemia

03-07-2013

Swiss drug major Roche (ROG: SIX) has announced today (July 3) that the US Food and Drug Administration…

obinutuzumabOncologypertuzumabPharmaceuticalRegulationRoche

Chugai gains Japanese approval for Perjeta and Bonviva

28-06-2013

Japanese drugmaker Chugai Pharmaceutical (TYO: 4519) said this morning (June 28) that it has obtained…

Anti-Arthritics/RheumaticsAsia-PacificBonvivaChugai PharmaceuticalOncologyPerjetaPharmaceuticalRegulationRoche

Additional indications in Japan for Roche's Avastin and Astellas' Prograf

17-06-2013

Swiss drug major Roche (ROG: SIX) says that the Japanese Ministry of Health, Labor and Welfare (MHLW)…

Asia-PacificAstellas PharmaAvastinBiotechnologyImmunologicalsOncologyPharmaceuticalPrografRegulationRoche

Regulatory briefs: Sanofi's Fluzone; Roche' RoActemra; Takeda's Rienso

10-06-2013

French pharma major Sanofi (Euronext: SAN) today (June 10) announced that the US Food and Drug Administration…

Anti-Arthritics/RheumaticsBiotechnologyPharmaceuticalRegulationRocheSanofiTakeda PharmaceuticalsVaccines

Proposal to list Roche's Neulastim and Actemra in New Zealand

24-05-2013

New Zealand's Pharmaceutical Management Agency PHARMAC has announce the approval of a proposal to list…

ActemraAnti-Arthritics/RheumaticsAsia-PacificNeulastimOncologyPharmaceuticalPricingRegulationRoche

FDA allows marketing of first A1c test labeled for diagnosing diabetes, from Roche

24-05-2013

The US Food and Drug Administration yesterday (May 23) announced that it is allowing marketing of the…

Cobas Integra 800DiabetesPharmaceuticalRegulationRoche

51 to 75 of 135 results

Back to top