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Teva gains full FDA approval of CML drug Synribo

Teva gains full FDA approval of CML drug Synribo

14-02-2014

Israel-based Teva Pharmaceutical Industries says the US Food and Drug Administration has granted full…

North AmericaOncologyPharmaceuticalRegulationSynriboTeva Pharmaceutical IndustriesUSA

Co-payments and co-insurance fees for drugs rise 34% under USA’s Affordable Care Act

Co-payments and co-insurance fees for drugs rise 34% under USA’s Affordable Care Act

14-02-2014

An examination of new health plans from 46 states in the USA revealed that co-payments and co-insurance…

FinancialHealthcareNorth AmericaPharmaceuticalUSA

FDA expands approval of Imbruvica to treat chronic lymphocytic leukemia

FDA expands approval of Imbruvica to treat chronic lymphocytic leukemia

13-02-2014

The US Food and Drug Administration yesterday expanded the approved use of US health care giant Johnson…

ImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulationUSA

Nearly 200 new medicines in development for diabetes by US drugmakers

12-02-2014

The USA’s biopharmaceutical research companies are currently developing 180 innovative new medicines…

DiabetesNorth AmericaPharmaceuticalResearch

FDA to review heart failure risk with AstraZeneca diabetes drug

FDA to review heart failure risk with AstraZeneca diabetes drug

12-02-2014

The US Food and Drug Administration has requested clinical trial data from Anglo-Swedish drug major AstraZeneca,…

AstraZenecaDiabetesKombiglyzeNorth AmericaOnglyzaPharmaceuticalRegulationResearchUSA

FDA advisory panel ambivalent on NSAID cardiovascular risk

FDA advisory panel ambivalent on NSAID cardiovascular risk

12-02-2014

The US Food and Drug Administration’s joint Arthritis Advisory Committee and Drug Safety and Risk Management…

Anti-Arthritics/RheumaticsBayerNaproxenNeurologicalNorth AmericaPfizerPharmaceuticalUSA

Report shows weak US oversight of drug discount program for the uninsured

Report shows weak US oversight of drug discount program for the uninsured

07-02-2014

A group of Republican Senate and House lawmakers in the USA released statements in response to a report…

North AmericaPharmaceuticalPoliticsUSA

Taking a cue from Apple and Coca-Cola, Big Pharma are humanizing brands

05-02-2014

By 2018, it is estimated that the global pharmaceutical market will be worth more than $1.3 trillion.…

Markets & MarketingNorth AmericaPharmaceuticalUSA

US HHS strengthens patients’ right to access lab test reports

US HHS strengthens patients’ right to access lab test reports

05-02-2014

As part of an ongoing effort to empower patients to be informed partners with their health care providers,…

HealthcareNorth AmericaPharmaceuticalRegulationUSA

FDA investigating risk of stroke, heart attack and death with testosterone products

FDA investigating risk of stroke, heart attack and death with testosterone products

03-02-2014

The US Food and Drug Administration said on Friday that it is investigating the risk of stroke, heart…

AbbVieActavisAndrodermAndroGelAxironEli LillyMen's HealthNorth AmericaPharmaceuticalRegulationResearchTestosteroneUSA

Sanofi sues Eli Lilly over Lantus patent infringement

Sanofi sues Eli Lilly over Lantus patent infringement

31-01-2014

French drug major Sanofi says it has filed a patent infringement suit against USA pharma firm Eli Lilly…

BiosimilarsDiabetesEli LillyLantusLegalNorth AmericaPatentsPharmaceuticalSanofiUSA

Avanir Pharma files NDA for migraine drug AVP-825

30-01-2014

US drugmaker Avanir Pharmaceuticals has submitted a New Drug Application to the US Food and Drug Administration…

Avanir PharmaceuticalsAVP-825NeurologicalNorth AmericaPharmaceuticalRegulationUSA

Teva gets FDA approval of three-times-a-week Copaxone

Teva gets FDA approval of three-times-a-week Copaxone

29-01-2014

Israel’s Teva Pharmaceutical Industries says that the US Food and Drug Administration has approved…

CopaxoneNeurologicalNorth AmericaPharmaceuticalRegulationTeva Pharmaceutical IndustriesUSA

FDA advisory panel backing for Merck/ALK ragweed allergy immunotherapy Ragwitek

FDA advisory panel backing for Merck/ALK ragweed allergy immunotherapy Ragwitek

28-01-2014

The US Food and Drug Administration’s Allergenic Products Advisory Committee has voted that the available…

Alk-AbelloImmunologicalsMerck & CoNorth AmericaPharmaceuticalRagwitekRegulationUSA

Heron Therapeutics says timeline for Sustol resubmission delayed

28-01-2014

US specialty pharma group Heron Therapeutics saw its shares plunge after the company revealed an around…

Heron TherapeuticsNorth AmericaOncologyPharmaceuticalRegulationSustolUSA

New US Breakthrough Therapy Designation has potential to shorten drug development time considerably

New US Breakthrough Therapy Designation has potential to shorten drug development time considerably

24-01-2014

The recently launched Breakthrough Therapy Designation (BTD) program in the USA, aimed at expediting…

North AmericaPharmaceuticalRegulation

Biopharma stepping up to improve STEM education in USA, new Battelle report finds

23-01-2014

In the USA, innovative biopharmaceutical companies and their corporate foundations are making significant…

ManagementNorth AmericaPharmaceuticalUSA

Record $122 million increase for Alzheimer's disease passed by US Congress

17-01-2014

An unprecedented $122 million increase for Alzheimer's research, education, outreach and caregiver support…

FinancialHealthcareNeurologicalNorth AmericaPharmaceuticalPoliticsResearchUSA

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

17-01-2014

The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has voted against…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

FDA recommends high-dose acetaminophen combo drugs be discontinued

FDA recommends high-dose acetaminophen combo drugs be discontinued

16-01-2014

The US Food and Drug Administration is recommending health care professionals discontinue prescribing…

NeurologicalNorth AmericaPharmaceuticalRegulationUSA

FDA advisory panel votes to approve Merck & Co’s vorapaxar

FDA advisory panel votes to approve Merck & Co’s vorapaxar

16-01-2014

There was a positive outcome for US pharma giant Merck & Co yesterday, when a US Food and Drug Administration…

Cardio-vascularMerck & CoNorth AmericaPharmaceuticalRegulationUSAvorapaxarZontivity

Merck starts roll-out of BLA for MK-3475; vorapaxar FDA panel review

Merck starts roll-out of BLA for MK-3475; vorapaxar FDA panel review

14-01-2014

US drug giant Merck & Co says it has started a rolling submission to the US Food and Drug Administration…

Cardio-vascularMerck & CoMK-3475North AmericaOncologyPharmaceuticalRegulationUSAvorapaxarZontivity

Daiichi Sankyo files Savaysa for US approval; collaborates with Virtici and Celdara Medical

Daiichi Sankyo files Savaysa for US approval; collaborates with Virtici and Celdara Medical

10-01-2014

Japanese drug major Daiichi Sankyo has filed a New Drug Application for its investigational, oral, once-daily…

Cardio-vascularCeldara MedicalDaiichi SankyoedoxabanNorth AmericaPharmaceuticalRegulationResearchSavaysaUSAVirtici

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