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FDA performs inspection of Impax's Taiwan facility

FDA performs inspection of Impax's Taiwan facility

30-07-2014

The US Food and Drug Administration has performed a general Good Manufacturing Practices (GMP) inspection…

Impax LaboratoriesNeurologicalPharmaceuticalRegulationRytaryUSA

AcelRx Pharma’s Zalviso approval delayed by FDA

AcelRx Pharma’s Zalviso approval delayed by FDA

28-07-2014

USA-based specialty pharma firm AcelRx Pharmaceuticals says that the US Food and Drug Administration…

AcelRxFood and Drug AdministrationNeurologicalPharmaceuticalRegulationUSAZalviso

FDA approves Purdue’s abuse-deterrent opioid Targiniq ER for pain-management

FDA approves Purdue’s abuse-deterrent opioid Targiniq ER for pain-management

25-07-2014

The US Food and Drug Administration has approved privately-held USA-based Purdue Pharma’s abuse-deterrent…

AlcoholsAnalgesiaChemistryNaloxonePharmaceuticalPurdue PharmaRegulationTarginiqUSA

Sandoz application for biosimilar Neupogen accepted by US FDA

25-07-2014

The US Food and Drug Administration has accepted the Biologics License Application for filgrastim, which…

AmgenBiosimilarsBiotechnologyFilgrastimNeupogenNovartisOncologyRegulationSandozUSAZarzio

Biogen Idec’s Plegridy approved in Europe for relapsing-remitting multiple sclerosis

Biogen Idec’s Plegridy approved in Europe for relapsing-remitting multiple sclerosis

24-07-2014

US biotech firm Biogen Idec said that the European Commission has approved its subcutaneous injectable…

Biogen IdecCytokinesMultiple sclerosisNeurologicalPharmaceuticalPlegridyRegulationUSA

US FDA approves Gilead’s Zydelig for three types of blood cancers

US FDA approves Gilead’s Zydelig for three types of blood cancers

24-07-2014

The US Food and Drug Administration late yesterday approved Zydelig (idelalisib), a new drug from US…

BiotechnologyGilead SciencesidelalisibOncologyRegulationUSAZydelig

Halozyme resumes enrolment and dosing of patients under revised protocol with US FDA

Halozyme resumes enrolment and dosing of patients under revised protocol with US FDA

22-07-2014

US-based pharmaceutical company Halozyme Therapeutics has said it is once again enrolling and dosing…

Halozyme TherapeuticsHyaluronidaseOncologyPancreatic cancerPEGylationPharmaceuticalRegulationUSA

Novasep sites approved by US FDA

Novasep sites approved by US FDA

22-07-2014

French active ngredients company Novasep has successfully completed US Food and Drug Administration pre-approval…

Active pharmaceutical ingredientFranceNovasepPharmaceuticalRegulationUSA

Valeant takes Allergan's 'false and misleading statements' to Quebec and US financial regulators

Valeant takes Allergan's 'false and misleading statements' to Quebec and US financial regulators

22-07-2014

In the latest in an ongoing takeover attempt of Allergan by Valeant, Valeant has contacted financial…

AllerganBausch & LombCanadaFinancialPharmaceuticalRegulationUSAValeant Pharmaceuticals

US breakthrough status for InterMune’s pirfenidone

US breakthrough status for InterMune’s pirfenidone

21-07-2014

US biotech firm InterMune’s Esbriet (pirfenidone) has been granted Breakthrough Therapy designation…

BiotechnologyEsbrietFood and Drug AdministrationInterMunepirfenidoneRare diseasesRegulationRespiratory and PulmonaryUSA

Pharming and Salix gain US approval for Ruconest

Pharming and Salix gain US approval for Ruconest

17-07-2014

Netherlands-based Pharming Group and Salix Pharmaceuticals have received approval from the US Food and…

BiotechnologyPharmingRare diseasesRegulationRuconestSalix PharmaceuticalsUSA

US breakthrough designation in IPF for Boehringer’s nintedanib

US breakthrough designation in IPF for Boehringer’s nintedanib

17-07-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation for German family-owned…

Boehringer IngelheimnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

Breakthrough therapy designation likely to positively influence oncologists

Breakthrough therapy designation likely to positively influence oncologists

15-07-2014

Breakthrough therapy designation is likely to positively influence perceptions of the drug for both oncologists…

Decision Resources GroupOncologyPharmaceuticalRegulationUSA

FDA accepts Teva’s NDA for albuterol MDPI

FDA accepts Teva’s NDA for albuterol MDPI

15-07-2014

Israel-based generic giant Teva Pharmaceuticals Industries says that the US Food and Drug Administration…

albuterolExercise-induced bronchospasmGenericsPulmonologyRegulationRespiratory and PulmonaryTeva Pharmaceutical IndustriesUSA

US Pharma and BIO appeal Alameda Ordinance on drug disposal

US Pharma and BIO appeal Alameda Ordinance on drug disposal

15-07-2014

The counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), joined by the Biotechnology…

LegalPharmaceuticalRegulationUSA

Janssen files to expand label for Invega Sustenna to show delayed time to relapse in schizophrenia

Janssen files to expand label for Invega Sustenna to show delayed time to relapse in schizophrenia

15-07-2014

US health care giant Johnson & Johnson’s Europe-based subsidiary Janssen has submitted a supplemental…

Invega SustennaJanssenNeurologicalPharmaceuticalRegulationSchizophreniaUSA

Medac’s Rasuvo approved for RA while Antares’ injunction is denied

Medac’s Rasuvo approved for RA while Antares’ injunction is denied

14-07-2014

USA-based Medac Pharma, a wholly-owned subsidiary of privately-held German firm medac GmbH, says that…

Antares PharmaAnti-Arthritics/RheumaticsLegalMedac PharmaPharmaceuticalRasuvoRegulationUSA

Lundbeck and Otsuka file for US approval of brexpiprazole

Lundbeck and Otsuka file for US approval of brexpiprazole

14-07-2014

Danish CNS drug specialist Lundbeck and Japanese drugmaker Otsuka have submitted a New Drug Application…

brexpiprazoleLundbeckMarkets & MarketingNeurologicalOtsukaPharmaceuticalPiperidinesRegulationUSA

US regulatory warnings on drug producers extend well beyond India

US regulatory warnings on drug producers extend well beyond India

14-07-2014

Hauled up by the US Food and Drug Administration for product recalls and quality issues, Indian pharmaceutical…

CiplaDr Reddy's LaboratoriesGenericsIndiaLupinProductionRanbaxy LaboratoriesRegulationSun PharmaceuticalUSA

Actavis confirms patent challenge to Duchesnay’s Diclegis

Actavis confirms patent challenge to Duchesnay’s Diclegis

12-07-2014

Ireland-based generics major Actavis on Friday confirmed that it has filed an Abbreviated New Drug Application…

ActavisDiclegisDuchesnayGenericsPatentsRegulationUSAWomen's Health

Sarepta tanks despite positive data on eteplirsen in Duchenne MD

Sarepta tanks despite positive data on eteplirsen in Duchenne MD

11-07-2014

US RNA-based drug developer Sarepta Therapeutics saw its shares plunge, despite the company releasing…

BiotechnologyeteplirsenRare diseasesRegulationResearchSarepta TherapeuticsUSA

Bristol-Myers to file Opdivo BLA earlier than expected

Bristol-Myers to file Opdivo BLA earlier than expected

10-07-2014

Following discussions with the US Food and Drug Administration, Bristol-Myers Squibb is planning a third…

Bristol-Myers SquibbnivolumabOncologyOpdivoPharmaceuticalRegulationUSA

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