Regulation - USA


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Mylan’s Matrix gets tentative FDA approval for novel "co-packaged" version of HIV/AIDS drug


US generic drugmaker Mylan (Nasdaq: MYL) says that its Indian subsidiary Matrix Laboratories has received…

Anti-viralsGenericsMatrixMylan LaboratoriesNorth AmericaRegulation

Malaysia Health Minister says new generics must not be delayed by interpretation of legislation


Malaysia does not want the introduction of new generic drugs to be obstructed and delayed by conflicting…


Citizen Petition calls on US FDA to review regulation of homeopathic drugs


The Center for Inquiry (CFI) and its affiliate, the Committee for Skeptical Inquiry (CSI), both non-profit…

BoironHealthcareNorth AmericaPharmaceuticalRegulation

Vivus agrees pathway with US FDA for re-submission of Qnexa NDA


There was a shot in the arm for US drug developer Vivus (Nasdaq: VVUS) yesterday, when the company said…

MetabolicsNorth AmericaPharmaceuticalQnexaRegulationVivus

HELP Committee hearings on securing US pharma supply chain in general agreement


There seemed to be broad agreement at a hearing convened this week by the US Senate Health, Education,…

GenericsMarkets & MarketingNorth AmericaPharmaceuticalPoliticsRegulation

UK’s NICE backs AstraZeneca’s new “clot-busting” drug Brilique to treat ACS


In final draft guidance published today, the UK drugs watchdog the National Institute of Health and Clinical…


US FDA warns of heart rhythm problems with GSK’s anti-nausea drug Zofran


The US Food and Drug Administration has notified health care professionals and patients of an ongoing…

GlaxoSmithKlineNorth AmericaOncologyPharmaceuticalRegulationZofran

New AHF ad campaign warns preventive use of Gilead AIDS drug Truvada is premature


The USA-based AIDS Healthcare Foundation (AHF) this week unveiled a new print ad that lays out data on…

Anti-viralsGilead SciencesMarkets & MarketingNorth AmericaPharmaceuticalRegulationTruvada

Nanobiotix starts clinical trial with lead product for soft tissue sarcoma


Nanobiotix, an emerging French nanomedicine company focused on cancer therapy, says that its lead compound,…


Astellas get EU approval for Vibativ for nosocomial pneumonia caused by MRSA


The European Commission has granted marketing authorization for Japanese drug major Astellas’ (TYO:…

Antibiotics and Infectious diseasesAstellas PharmaEuropePharmaceuticalRegulationTheravanceVibativ

One-third of changes to clinical trial protocols are avoidable, says Tufts CSDD


Nearly 60% of all protocols used in clinical trials for new drugs are amended during the trial. Moreover,…

BiotechnologyNorth AmericaPharmaceuticalRegulationResearch

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


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

BiotechnologyCurisGenentechNorth AmericaOncologyPharmaceuticalRegulationRochevismodegib

SMC backs Celgene’s Vidaza for rare blood and bone marrow cancers in Scotland


The Scottish Medicines Consortium (SMC), the equivalent of the UK’s drug watchdog the National Institute…


European Fine Chemicals Group ratifies US FDA's proposed Generic Drug User Fees Act


The board of the European Fine Chemicals Group (EFCG) says that it has agreed to ratify the proposal…

FinancialGenericsNorth AmericaRegulation

Draft guidance from UK's NICE recommends clinical trial for COPD drug Daxas


New draft guidance from the UK's drug watchdog the National Institute for Health and Clinical Excellence…

DaxasEuropeMerck & CoNycomedPharmaceuticalPricingRegulationRespiratory and Pulmonary

Global pharmacovigilance spending forecast to reach $15.46 billion by 2015


Spending on pharmacovigilance will reach a value of $15.46 billion by 2015, compared with just under…


Disappointing FDA briefing papers on Bayer/J&J’s Xarelto


US Food and Drug Administration staffers posted a negative picture for German drug major Bayer (BAY:…

BayerCardio-vascularJohnson & JohnsonNorth AmericaPharmaceuticalRegulationXarelto

Takeda’s Mepact backed by UK’s NICE for osteosarcoma, after previous negative opinion


In a U-turn by the UK drug watchdog, in its latest appraisal, the National Institute for Health and Clinical…

EuropeMepactOncologyPharmaceuticalPricingRegulationTakeda Pharmaceuticals

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