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US FDA expands use of Bristol-Myers’ Opdivo to NSCLC

US FDA expands use of Bristol-Myers’ Opdivo to NSCLC

05-03-2015

The US Food and Drug Administration late yesterday expanded the approved use of pharma major Bristol-Myers…

BiotechnologyBristol-Myers SquibbOncologyOpdivoRegulationUSA

FDA accepts Bayer's BLA for hemophilia A agent Kovaltry

FDA accepts Bayer's BLA for hemophilia A agent Kovaltry

04-03-2015

The US Food and Drug Administration has accepted German pharma major Bayer’s Biologics License Application…

BAY 81-8973BayerBiotechnologyHematologyKovaltryRegulationUSA

US FDA warns on over-prescribing of testosterone products

US FDA warns on over-prescribing of testosterone products

04-03-2015

The US Food and Drug Administration is requiring that the manufacturers of all approved prescription…

AbbVieAndroGelAxironEli LillyMen's HealthPharmaceuticalRegulationUSA

Orexigen shares jump on Contrave trial interim data but FDA orders more cardio studies

Orexigen shares jump on Contrave trial interim data but FDA orders more cardio studies

04-03-2015

The US Food and Drug Administration has said it is “disappointed” by Orexigen Therapeutics’ decision…

ContraveMetabolicsNeurologicalOrexigen TherapeuticsPharmaceuticalRegulationUSA

FDA formally accepts Actelion's NDA for Uptravi

FDA formally accepts Actelion's NDA for Uptravi

04-03-2015

Switzerland-based Actelion, Europe’s largest biotech company, says that the US Food and Drug Administration…

ActelionBiotechnologyRegulationRespiratory and PulmonaryselexipagUptraviUSA

Oncolytics Biotech gains third orphan status for Reolysin

Oncolytics Biotech gains third orphan status for Reolysin

03-03-2015

Canada’s Oncolytics Biotech revealed today that the US Food and Drug Administration has granted Orphan…

BiotechnologyOncologyOncolytics BiotechRare diseasesRegulationReolysinUSA

FDA declines to expand approval of Pacira's Exparel for postsurgical analgesia

FDA declines to expand approval of Pacira's Exparel for postsurgical analgesia

03-03-2015

The US Food and Drug Administration has declined to expand the approval of Exparel (bupivacaine), manufactured…

AnalgesiaExparelPacira PharmaceuticalsPharmaceuticalRegulationUSA

Positive Ph III results for Portola’s Xarelto antidote andexanet alfa

02-03-2015

USA-based Portola Pharmaceuticals saw its shares jump 7.2% to $40.83 after it announced positive results…

andexanet alfaBayerBiotechnologyCardio-vascularPortola PharmaceuticalsRegulationResearchUSA

Boehringer Ingelheim files BLA with FDA for Pradaxa antidote idarucizumab

02-03-2015

German family-owned pharma major Boehringer Ingelheim has submitted a Biologics License Application (BLA)…

BiotechnologyBoehringer IngelheimCardio-vascularidarucizumabPradaxaRegulationUSA

Shire files for US approval of Lifitegrast for dry eye disease

02-03-2015

Ireland-based drugmaker Shire has submitted a New Drug Application with the US Food and Drug Administration…

BiotechnologyEBI-005Eleven BiotherapeuticsLifitegrastOphthalmicsRegulationShireUSA

‘New option’ for diabetes as Sanofi receives FDA approval of Toujeo

‘New option’ for diabetes as Sanofi receives FDA approval of Toujeo

26-02-2015

The US Food and Drug Administration has approved French pharma major Sanofi’s Toujeo (insulin glargine…

DiabetesPharmaceuticalRegulationSanofiToujeoUSA

US FDA approves new antibacterial drug Avycaz

US FDA approves new antibacterial drug Avycaz

26-02-2015

The US Food and Drug Administration has approved antibacterial drug Avycaz (ceftazidime-avibactam) to…

ActavisAntibiotics and Infectious diseasesceftazidime-avibactamForest PharmaceuticalsPharmaceuticalRegulationUSA

Biosimilars viable only for biologics with sales of $898 million, says Prime Therapeutics report

Biosimilars viable only for biologics with sales of $898 million, says Prime Therapeutics report

26-02-2015

Although there is widespread optimism around the first biosimilars being launched in the USA, a new report…

BiosimilarsProductionRegulationUnited StatesUSA

Federal Trade Commission puts conditions on Novartis acquisition of GSK oncology portfolio

Federal Trade Commission puts conditions on Novartis acquisition of GSK oncology portfolio

24-02-2015

The US Federal Trade Commission has put conditions on the proposed acquisition by Novartis of GlaxoSmithKline’s…

Array BioPharmaGSKLegalMergers & AcquisitionsNovartisOncologyPharmaceuticalRegulationResearchUSA

US FDA approves Novartis’ Farydak, the first HDAC inhibitor for MM patients

24-02-2015

The US Food and Drug Administration yesterday approved Swiss pharma giant Novartis’ Farydak (panobinostat,…

FarydakNovartisOncologypanobinostatPharmaceuticalRegulationUSA

Eli Lilly delays US and Europe filings for new diabetes agent peglispro

23-02-2015

US pharma major Eli Lilly says it is delaying the submission of its basal insulin peglispro (BIL) to…

DiabetesEli LillyEuropepeglisproPharmaceuticalRegulationUSA

FDA accepts for review Synageva's Biologics License Application for Kanuma

FDA accepts for review Synageva's Biologics License Application for Kanuma

23-02-2015

The US Food and Drug Administration has accepted for review the Biologics License Application for Kanuma…

BiotechnologyGeneticsKanumaRegulationSynageva BioPharmaUSA

Actavis receives final FDA approval for generic version of Subutex

Actavis receives final FDA approval for generic version of Subutex

22-02-2015

Ireland-headquartered generics major Actavis has received final approval from the US Food and Drug Administration…

Abbreviated New Drug ApplicationGenericsIndiviorNeurologicalRC PharmaceuticalsReckitt BenckiserRegulationSubutexUSA

FDA accepts and grants priority review for Genentech's cobimetinib/Zelboraf

FDA accepts and grants priority review for Genentech's cobimetinib/Zelboraf

20-02-2015

Genentech, part of the Roche Group, says that the US Food and Drug Administration has accepted and granted…

cobimetinibGenentechOncologyPharmaceuticalRegulationRocheUSA

US FDA expands use of Celgene’s Revlimid

18-02-2015

US biotech firm Celgene revealed that the US Food and Drug Administration has expanded the existing indication…

BiotechnologyCelgene CorpOncologyRegulationRevlimidUSA

FDA issues new draft documents related to compounding of human drugs

FDA issues new draft documents related to compounding of human drugs

17-02-2015

The US Food and Drug Administration issued five draft documents related to drug compounding and repackaging…

FDAHealthPharmaceuticalPharmaceutical sciencesPharmacologyRegulationSterile compounded drug productsUSA

Sprout Pharmaceuticals resubmits flibanserin to the FDA for women's hypoactive sexual desire disorder

Sprout Pharmaceuticals resubmits flibanserin to the FDA for women's hypoactive sexual desire disorder

17-02-2015

Privately-held US sexual health specialists Sprout Pharmaceuticals has resubmitted its New Drug Application…

flibanserinPharmaceuticalRegulationSprout PharmaceuticalsUSAWomen's Health

FDA conference highlights: Agency focuses on pediatric therapies to treat rare diseases

FDA conference highlights: Agency focuses on pediatric therapies to treat rare diseases

17-02-2015

In a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies looks the…

FDAPharmaceuticalPharmacologyRegulationUSA

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