Pharmaceutical - Immunologicals, North America

Filter

Popular Filters

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

Veloxis Pharma submits NDA for Envarsus in kidney transplant recipients

30-12-2013

Denmark’s Veloxis Pharmaceuticals has submitted a New Drug Application to the US Food and Drug Administration…

EnvarsusImmunologicalsLCP-TacroNorth AmericaPharmaceuticalRegulationUSAVeloxis Pharmaceuticals

Unanimous FDA panel support for Merck & Co’s Grastek

Unanimous FDA panel support for Merck & Co’s Grastek

13-12-2013

The Allergenic Products Advisory Committee (APAC) of the US Food and Drug Administration yesterday voted…

Alk-AbelloGrastekGrazaxImmunologicalsMerck & CoNorth AmericaPharmaceuticalRegulation

Stallergenes' Oralair gains US FDA panel backing

Stallergenes' Oralair gains US FDA panel backing

12-12-2013

France’s Stallergenes said late yesterday that the Allergenic Products Advisory Committee (APAC) of…

GREER LaboratoriesImmunologicalsNorth AmericaOralairPharmaceuticalRegulationStallergenes

Baxter files amended BLA to FDA for HyQvia for primary immunodeficiency

Baxter files amended BLA to FDA for HyQvia for primary immunodeficiency

02-12-2013

USA-based Baxter International has completed submission of an amended biologics license application to…

Baxter InternationalHalozyme TherapeuticsHyQviaImmunologicalsNorth AmericaPharmaceuticalRegulationUSA

Immunologist Yong-Jun Liu named head of research at MedImmune

Immunologist Yong-Jun Liu named head of research at MedImmune

20-11-2013

US-based MedImmune, the global biologics research and development arm of Anglo-Swedish drug major AstraZeneca…

BoardroomImmunologicalsMedImmuneNorth AmericaPharmaceuticalUSA

Merck’s investigational Timothy grass allergy tablet reduced symptoms in Phase III study

Merck’s investigational Timothy grass allergy tablet reduced symptoms in Phase III study

12-11-2013

US pharma giant Merck & Co (NYSE: MRK) has published positive results for its investigational Timothy…

ALK AbelloGrazaxImmunologicalsMerck & CoNorth AmericaPharmaceuticalResearchUSA

Greer Labs and Stallergenes in deal for Oralair in USA

31-10-2013

French allergy specialists Stallergenes and USA-based Greer Laboratories have signed an exclusive agreement…

GREER LaboratoriesImmunologicalsLicensingNorth AmericaOralairPharmaceuticalStallergenes

ALK’s allergy tablet falls victim to US government shutdown

ALK’s allergy tablet falls victim to US government shutdown

08-10-2013

ALK Abello is the first pharma casualty of the US government shutdown.

ALK AbelloImmunologicalsMerk & CoNorth AmericaPharmaceuticalRegulation

Pfizer legacy company agrees near half billion dollar settlement with DoJ

31-07-2013

Wyeth Pharmaceuticals, a US pharma rival acquired by US behemoth Pfizer (NYSE:PFE) in 2009, has agreed…

FinancialImmunologicalsLegalMarkets & MarketingNorth AmericaPfizerPharmaceuticalRapamuneWyeth

FDA backs Astellas' Astragraf XL for kidney transplant rejection prophylaxis

22-07-2013

The US Food and Drug Administration has approved Japanese drug major Astellas Pharma's (TYO: 4503) Astragraf…

Astellas PharmaAstragraf XLImmunologicalsNorth AmericaPharmaceuticalRegulationtacrolimus

US FDA accepts Merck & Co's BLA ragweed pollen allergy immunotherapy

09-05-2013

US pharma giant Merck & Co (NYSE: MRK) revealed yesterday (May 8) that the Biologics License Application…

Alk-AbelloBiotechnologyImmunologicalsMerck & CoNorth AmericaPharmaceuticalRegulation

Merck & Co submits ragweed AIT BLA to the FDA

11-03-2013

US pharma giant Merck & Co (NYSE: MRK) has submitted a Biologics License Application (BLA) to the US…

ALK AbelloFinancialImmunologicalsMerck & CoNorth AmericaPharmaceuticalRegulation

Novartis' Zortress first drug in over a decade approved by FDA to prevent organ rejection

18-02-2013

Swiss drug major Novartis (NOVN: VX) said on Friday that the US Food and Drug Administration has approved…

ImmunologicalsNorth AmericaNovartisPharmaceuticalRegulationZortress

Pfizer prevails in Rapamune patent dispute with Watson

01-02-2013

Global pharma behemoth Pfizer (NYSE: PFE) says that the US District Court for the District of Delaware…

ActavisGenericsImmunologicalsLegalNorth AmericaPatentsPfizerPharmaceuticalRapamuneWatson Pharmaceuticals

FDA advisory gives negative opinion on Hemispherx' Ampligen

27-12-2012

The Arthritis Advisory Committee (AAC) of the US Food and Drug Administration last week voted against…

AmpligenBiotechnologyHemispherx BioPharmaImmunologicalsNorth AmericaPharmaceuticalRegulation

News briefs: setbacks for B-MS hep C drug; Baxter's HyQ

02-08-2012

US drug major Bristol-Myers Squibb (NYSE: BMY) has suspended study drug administration in ongoing Phase…

Anti-viralsBaxter InternationalBMS-986094Bristol-Myers SquibbHyQImmunologicalsNorth AmericaPharmaceuticalRegulationResearch

FDA calls for more data on Merck combo drug; Good results with allergy drug

06-03-2012

The US Food and Drug Administration (FDA) has issued a Complete Response Letter to drug giant Merck &…

ALK AbelloatorvastatinCardio-vascularezetimibeImmunologicalsMerck & CoNorth AmericaPharmaceuticalRegulationResearch

FDA gives Hemispherx time to respond to CRL

12-01-2012

Shares of USA-based Hemispherx Biopharma (NYSE Amex: HEB) rose 14% to $0.24 on Wednesday, after the company…

AmpligenHemispherx BioPharmaImmunologicalsNorth AmericaPharmaceuticalRegulation

Back to top