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

21-09-2011

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

20-09-2011

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

Asia-PacificGenericsLegalRegulation

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

18-09-2011

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

16-09-2011

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

16-09-2011

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

16-09-2011

In final draft guidance published today, the UK drugs watchdog the National Institute of Health and Clinical…

AstraZenecaBrilintaBriliqueCardio-vascularEuropePharmaceuticalRegulation

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

16-09-2011

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

15-09-2011

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

15-09-2011

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

NanobiotixOncologyPharmaceuticalRegulationResearch

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

15-09-2011

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

13-09-2011

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

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

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

12-09-2011

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

BiotechnologyCelgeneEuropeOncologyPharmaceuticalPricingRegulationVidaza

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

11-09-2011

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

09-09-2011

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

08-09-2011

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

BiotechnologyFinancialGlobalPharmaceuticalRegulation

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

07-09-2011

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

07-09-2011

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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