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FDA advisory backs expanded use of Vertex’ CF drug

22-10-2014

There was good news for US biotech firm Vertex Pharmaceuticals yesterday, as a US Food and Drug Administration…

BiotechnologyKalydecoRare diseasesRegulationUSAVertex Pharmaceuticals

EMA urging firms with Ebola candidates to seek orphan status

21-10-2014

The European Medicines Agency is aiming to encourage developers of treatments or vaccines against Ebola…

Anti-viralsEuropePharmaceuticalRare diseasesRegulationResearchUSA

Auxilium's supplemental Biologics Application for Xiaflex approved by FDA

Auxilium's supplemental Biologics Application for Xiaflex approved by FDA

21-10-2014

Specialty biopharma company Auxilium Pharmaceuticals has received approval from the US Food And Drug…

Anti-Arthritics/RheumaticsAuxilium PharmaceuticalsBiotechnologyRegulationUSAXiaflex

FDA panel unanimously backs Novartis’ secukinumab for moderate-to-severe plaque psoriasis

FDA panel unanimously backs Novartis’ secukinumab for moderate-to-severe plaque psoriasis

21-10-2014

The Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration…

DermatologicalsNovartisPharmaceuticalRegulationsecukinumabUSA

FDA fast-tracks Taiho Oncology’s TAS-102 for colorectal cancer

FDA fast-tracks Taiho Oncology’s TAS-102 for colorectal cancer

20-10-2014

The US Food and Drug Administration has granted Fast Track designation for TAS-102 (trifluridine and…

OncologyOtsukaPharmaceuticalRegulationTaiho OncologyTAS-102USA

Pharmacyclics files Imbruvica sNDA for Waldenstrom’s macroglobulinemia

20-10-2014

US drugmaker Pharmacyclics has submitted a supplemental New Drug Application to the US Food and Drug…

ImbruvicaJanssen BiotechJohnson & JohnsonOncologyPharmaceuticalPharmacyclicsRegulationUSA

US FDA backs abuse deterrent labeling for Pfizer’s Embeda ER

19-10-2014

The US Food and Drug Administration has approved an updated label for pharma giant Pfizer’s Embeda…

AvinzaEmbedaNeurologicalPfizerPharmaceuticalRegulationUSA

US FDA panel votes to keep Chantix black box warning; staffers recommend secukinumab

US FDA panel votes to keep Chantix black box warning; staffers recommend secukinumab

17-10-2014

The US Food and Drug Administration's advisory panel has voted to keep a black box warning on US pharma…

ChantixNovartisPfizerPharmaceuticalRegulationsecukinumabUSA

Actavis challenges Quillivant XR patent

16-10-2014

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

ActavisGenericsLegalNeurologicalPatentsPfizerQuillivantRegulationTris PharmaUSA

FDA FOCUS: The medical marijuana controversy

FDA FOCUS: The medical marijuana controversy

16-10-2014

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

MarinolPharmaceuticalRegulationUnited StatesUSA

US FDA approves Genentech’s Esbriet and Boehringer Ingelheim’s Ofev for IPF

US FDA approves Genentech’s Esbriet and Boehringer Ingelheim’s Ofev for IPF

16-10-2014

The US Food and Drug Administration has approved Esbriet (pirfenidone), from Roche subsidiary Genentech,…

Boehringer IngelheimEsbrietGenentechnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

FDA grants priority reviews for Eisai's for rufinamide and lenvatinib

FDA grants priority reviews for Eisai's for rufinamide and lenvatinib

15-10-2014

There was good news for Japanese drugmaker Eisai yesterday, as the US Food and Drug Administration granted…

BanzelEisailenvatinibNeurologicalOncologyPharmaceuticalRegulationRufinamide TabletsUSA

FDA consent decree with Ascend Labs backed by federal judge

FDA consent decree with Ascend Labs backed by federal judge

15-10-2014

A federal judge from the US District Court for the Southern District of Ohio entered a consent decree…

Ascend LaboratoriesGenericsLegalProductionRegulationUSA

Pfizer’s palbociclib gains FDA Priority Review

13-10-2014

Pfizer says that the New Drug Application for its investigational breast cancer treatment palbociclib…

OncologypalbociclibPfizerPharmaceuticalRegulationUSA

FDA approves Eisai’s Akynzeo for CINV

13-10-2014

The US Food and Drug Administration has approved Japanese pharma major Eisai’s Akynzeo (netupitant…

AkynzeoEisaiHelsinnnetupitantOncologypalonosetronPharmaceuticalRegulationUSA

FDA approves Gilead’s Harvoni, the first combo pill for hepatitis C

FDA approves Gilead’s Harvoni, the first combo pill for hepatitis C

12-10-2014

As was largely expected, the US Food and Drug Administration on Friday approved biotech firm Gilead Sciences’…

Anti-viralsBiotechnologyGilead SciencesHarvoniPricingRegulationSovaldiUSA

US orphan designation for DNAtrix’ DNX-2401 in malignant glioma

US orphan designation for DNAtrix’ DNX-2401 in malignant glioma

09-10-2014

US privately-held oncolytic virus expert DNAtrix says that the US Food and Drug Administration has granted…

BiotechnologyDNAtrixDNX-2401OncologyRegulationUSA

US FDA grants Fast Track status to BrainStorm Cell Therapeutics for ALS treatment NurOwn

US FDA grants Fast Track status to BrainStorm Cell Therapeutics for ALS treatment NurOwn

07-10-2014

The US Food and Drug Administration has designated a product from stem cell treatment developer BrainStorm…

BiotechnologyBrainStorm Cell TherapeuticsNeurologicalNurOwnRegulationUSA

Regeneron gains further FDA indications for Eylea

Regeneron gains further FDA indications for Eylea

07-10-2014

The US Food and Drug Administration has approved biotech firm Regeneron Pharmaceuticals’ Eylea (aflibercept)…

BayerBiotechnologyEyleaOphthalmicsRegeneron PharmaceuticalsRegulationUSA

Brilinta preferred over clopidogrel in latest AHA/ACC guideline

Brilinta preferred over clopidogrel in latest AHA/ACC guideline

06-10-2014

Anglo-Swedish pharma major AstraZeneca today confirmed that the American Heart Association (AHA) and…

AstraZenecaBrilintaCardio-vascularClopidogrelDaiichi SankyoEli LillyPharmaceuticalprasugrelRegulationSanofiticagrelorUSA

AbbVie gains expanded approval for Humira by FDA

AbbVie gains expanded approval for Humira by FDA

06-10-2014

US drugmaker AbbVie has received approval from the US Food and Drug Administration for an extension of…

AbbVieAnti-Arthritics/RheumaticsHumiraPharmaceuticalRegulationUSA

Orphan status for Horizon Pharma’s Actimmune in Friedreich's ataxia

Orphan status for Horizon Pharma’s Actimmune in Friedreich's ataxia

04-10-2014

The US Food and Drug Administration has granted orphan drug designation for Ireland-headquartered specialty…

ActimmuneBiotechnologyHorizon PharmaRare diseasesRegulationUSA

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