Regulation - North America, Antibiotics and Infectious diseases

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FDA advisory unanimously recommends Durata’s Dalvance

FDA advisory unanimously recommends Durata’s Dalvance

01-04-2014

The US Food and Drug Anti-Infective Drugs Advisory Committee voted 12 to 0 that Durata Therapeutics’…

Antibiotics and Infectious diseasesDalvanceDermatologicalsDurata TherapeuticsNorth AmericaPharmaceuticalRegulationUSA

FDA approves label changes for Doribax to reflect risks

10-03-2014

The US Food and Drug Administration has approved label changes for the antibacterial Doribax (doripenem)…

Antibiotics and Infectious diseasesDoribaxNorth AmericaPharmaceuticalRegulationShionogiUSA

FDA accepts The Medicines Company's NDA for oritavancin with priority review

FDA accepts The Medicines Company's NDA for oritavancin with priority review

19-02-2014

The US Food and Drug Administration has accepted the filing of The Medicines Company’s New Drug Application…

Antibiotics and Infectious diseasesNorth AmericaoritavancinPharmaceuticalRegulationThe Medicines CompanyUSA

Cubist’s tedizolid NDA accepted for priority review in USA

Cubist’s tedizolid NDA accepted for priority review in USA

31-12-2013

The US Food and Drug Administration has accepted Cubist Pharmaceuticals’ New Drug Application for its…

Antibiotics and Infectious diseasesBayerCubist PharmaceuticalsNorth AmericaPharmaceuticalRegulationtedizolidTrius TherapeuticsUSA

New Ph III data support early 2014 filing for Cubist’s ceftolozane/tazobactam

New Ph III data support early 2014 filing for Cubist’s ceftolozane/tazobactam

17-12-2013

US drugmaker Cubist Pharmaceuticals saw its shares jump 8.3% to $68 in premarket trading yesterday, when…

Antibiotics and Infectious diseasesceftolozoneCubist PharmaceuticalsEuropeNorth AmericaPharmaceuticalRegulationResearchtazobactam

FDA accepts priority review of Durata NDA for Dalvance

FDA accepts priority review of Durata NDA for Dalvance

27-11-2013

Shares of Durata Therapeutics leapt 13.4%, following the news that the New Drug Application for its investigational…

Antibiotics and Infectious diseasesCubicinDalvanceDurata TherapeuticsNorth AmericaPharmaceuticalRegulation

FDA issues new Boxed Warning on Pfizer antibacterial

FDA issues new Boxed Warning on Pfizer antibacterial

28-09-2013

The US Food and Drug Administration is warning that an additional analysis shows an increased risk of…

Antibiotics and Infectious diseasesNorth AmericaPfizerPharmaceuticalRegulationTygacil

Warning over Janssen's Nizoral tablets

30-07-2013

The US Food and Drug Administration is taking action over anti-fungal Nizoral (ketoconazole) oral tablets…

Antibiotics and Infectious diseasesJanssen PharmaceuticaNizoralNorth AmericaPharmaceuticalRegulation

QIDP designation for Tetraphase's lead antibiotic candidate

21-07-2013

The US Food and Drug Administration has designated biotech company Tetraphase Pharmaceuticals' (Nasdaq:…

Antibiotics and Infectious diseasesBiotechnologyeravacyclineNorth AmericaRegulationTetraphase Pharmaceuticals

Briefs: Boehringer files Pradaxa for DVT and PE; Astellas' Mycamine pediatric approval; Simcere divests Boda

25-06-2013

Family-owned German drug major Boehringer Ingelheim has submitted an application to the European Medicines…

Antibiotics and Infectious diseasesAstellas PharmaBoehringer IngelheimCardio-vascularEuropeJilin BodaMergers & AcquisitionsNorth AmericaPharmaceuticalRegulationSimcere PharmaceuticalYidashen

Briefs: Added use for Theravance's Vibativ; approval sought for ViiV dolutegravir; FDA accepts Pfizer sNDA for Xeljanz

23-06-2013

USA-based Theravance (Nasdaq: THRX) says that the US Food and Drug Administration has approved the firm's…

Anti-Arthritics/RheumaticsAnti-viralsAntibiotics and Infectious diseasesBiotechnologydolutegravirNorth AmericaPfizerPharmaceuticalRegulationTheravanceVibativViiV HealthcareXeljanz

FDA grants "Breakthrough Therapy" status for Alexion's asfotase in HPP; issues CRL for Valeant's efinaconazole

28-05-2013

US drugmaker Alexion Pharmaceuticals (Nasdaq: ALXN) says that the Food and Drug Administration has granted…

Alexion PharmaceuticalsAntibiotics and Infectious diseasesasfotase alfaefinaconazoleNorth AmericaPharmaceuticalRare diseasesRegulationValeant Pharmaceuticals

Breakthrough status for Pfizer's palbociclib; Merck & Co Noxafil NDA accepted

11-04-2013

Global pharma behemoth Pfizer (NYSE: PFE) is the latest to gain a "Breakthrough Therapy" designation…

Antibiotics and Infectious diseasesMerck & CoNorth AmericaNoxafilOncologypalbociclibPfizerPharmaceuticalRegulation

FDA approves Novartis' TOBI Podhaler and Cangene's first Botulism Antitoxin heptavalent

24-03-2013

The US Food and Drug Administration on Friday approved Swiss drug major Novartis' (NOVN: VX) TOBI Podhaler…

Antibiotics and Infectious diseasesBotulism antitoxinCangeneNorth AmericaNovartisPharmaceuticalRegulationRespiratory and PulmonaryTobi Podhaler

Merck & Co gets all clear to continue Vytorin study; FDA warns on Pfizer's Zithromax

13-03-2013

US pharma giant Merck & Co said yesterday that the Data Safety Monitoring Board (DSMB) of the IMPROVE-IT…

Antibiotics and Infectious diseasesCardio-vascularMerck & CoNorth AmericaPfizerPharmaceuticalRegulationResearchVytorinZithromax

Janssen's TB drug Sirturo gains US FDA approval

02-01-2013

The US Food and Drug Administration has granted accelerated approval for US health care major Johnson…

Antibiotics and Infectious diseasesbedaquilineJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationSirturo

Public Citizen urges FDA to reject accelerated approval for Janssen's bedaquiline

27-12-2012

The US Food and Drug Administration should not approve the anti-tuberculosis drug bedaquiline from Janssen,…

Antibiotics and Infectious diseasesbedaquilineJohnson & JohnsonNorth AmericaPharmaceuticalRegulation

US FDA approvals for Signifor, raxibacumab and Iclusig

17-12-2012

In a flurry of activity from the US Food and Drug Administration on Friday, the agency - which looks…

Antibiotics and Infectious diseasesAriad PharmaceuticalsGlaxoSmithKlineIclusigNorth AmericaNovartisOncologyPharmaceuticalRare diseasesraxibacumabRegulationSignifor

FDA staffers seem to back safety of Janssen bedaquiline (Sirturo)

27-11-2012

Ahead of the November 28 meeting of the US Food and Drug Administration's Anti-Infective Drugs Advisory…

Antibiotics and Infectious diseasesbedaquilineJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySirturo

GlaxoSmithKline amends accord with Isis Pharma; gets FDA panel backing for raxibacumab

06-11-2012

USA-based Isis Pharmaceuticals (Nasdaq: ISIS) says it has agreed to amend the clinical development plan…

Antibiotics and Infectious diseasesBiotechnologyFinancialGlaxoSmithKlineIsis PharmaceuticalsISIS-TTR.RXLicensingNorth AmericaPharmaceuticalRare diseasesraxibacumabRegulationResearch

US FDA pulls 27 Ranbaxy ANDAs approvals under consent decree

23-08-2012

The Food and Drug Administration is withdrawing approval of 27 Abbreviated New Drug Applications (ANDAs)…

Antibiotics and Infectious diseasesDaiichi SankyoDiabetesGenericsNorth AmericaRanbaxy LaboratoriesRegulation

Human Genome resubmits raxibacumab BLA

11-07-2012

US biotech firm Human Genome Sciences (Nasdaq: HGSI), the subject of a hostile takeover bid from GlaxoSmithKline,…

Antibiotics and Infectious diseasesBiotechnologyHuman Genome SciencesNorth AmericaraxibacumabRegulation

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