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UK Cancer Drugs Fund to re-assess procedure and currently-approved drugs

UK Cancer Drugs Fund to re-assess procedure and currently-approved drugs

13-11-2014

The UK’s National Health Service has updated its procedure for evaluating drugs in the Cancer Drugs…

AvastinKadcylaOncologyPharmaceuticalRegulationSprycelUK

FDA approves sNDA for Janssen's Invega Sustenna in schizoaffective disorder

FDA approves sNDA for Janssen's Invega Sustenna in schizoaffective disorder

13-11-2014

The US Food and Drug Administration has approved the supplemental New Drug Applications (sNDAs) from…

Invega SustennaJanssenNeurologicalPharmaceuticalRegulationUSA

Actavis' sNDA accepted by FDA for Saphris in bipolar I disorder

Actavis' sNDA accepted by FDA for Saphris in bipolar I disorder

13-11-2014

Ireland-headquartered generics major Actavis has had its Supplemental New Drug Application for Saphris…

ActavisIrelandNeurologicalPharmaceuticalRegulationSaphris

Par Pharmaceuticals receives FDA approval for Vasostrict in low blood pressure

Par Pharmaceuticals receives FDA approval for Vasostrict in low blood pressure

13-11-2014

Generic and branded specialty pharma company Par Pharmaceuticals has received approval for its New Drug…

HematologyPar PharmaceuticalsPharmaceuticalRegulationUSAVasostrict

SMC accepts Eylea and Onglyza for use in NHS Scotland

SMC accepts Eylea and Onglyza for use in NHS Scotland

13-11-2014

The Scottish Medicines Consortium (SMC) has accepted German drugmaker Bayer’s Eylea (aflibercept solution…

AstraZenecaBayerDiabetesEyleaOnglyzaPharmaceuticalRegulationUK

GlaxoSmithKline files for added Revolade indication in EU

12-11-2014

UK pharma major GlaxoSmithKline has filed an application with the European Medicines Agency for a variation…

EuropeGlaxoSmithKlineLigand PharmaceuticalsOncologyPharmaceuticalPromactaRare diseasesRegulationRevolade

Polyphor’s POL7080 receives QIDP designation from the FDA

12-11-2014

Privately-held Swiss pharma firm Polyphor says that the US Food and Drug Administration has designated…

Antibiotics and Infectious diseasesPharmaceuticalPOL7080PolyphorRegulationRocheUSA

Durect to ‘refine the path’ of Posidur program

Durect to ‘refine the path’ of Posidur program

12-11-2014

US drugmaker Durect Corporation says that it has received meeting minutes from its face-to-face meeting…

AnalgesiaDurectPharmaceuticalPosidurRegulationUSA

Canada passes Vanessa's Law on unsafe medicines

Canada passes Vanessa's Law on unsafe medicines

11-11-2014

New legislation known as Vanessa’s Law (Bill C 17; the Protecting Canadians from Unsafe Drugs Act)…

CanadaMinister of HealthPharmaceuticalPoliticsRegulation

India takes action on spurious and sub-standard drugs

India takes action on spurious and sub-standard drugs

10-11-2014

An American pharmacist and an Indian pharmacologist charged with smuggling four million fake pharmaceuticals…

GenericsIndiaMarkets & MarketingPharmaceuticalPoliticsRegulation

Two Bristol-Myers Squibb drugs approved by Scottish Medicines Consortium

Two Bristol-Myers Squibb drugs approved by Scottish Medicines Consortium

10-11-2014

The Scottish Medicines Consortium has approved two new treatments today, one for skin cancer and one…

Bristol-Myers SquibbDaklinzaNephrology and HepatologyOncologyPharmaceuticalRegulationUKYervoy

Scottish backing for Novartis’ Afinitor for kidney cancer patients

Scottish backing for Novartis’ Afinitor for kidney cancer patients

10-11-2014

The Scottish Medicines Consortium has issued a positive recommendation for Swiss pharma major Novartis’…

AfinitorClinical pharmacologyHealthHealth Medical PharmaNHSNovartisOncologyPharmaceuticalPricingRegulationUK

FDA Focus: The Sherley Amendment

FDA Focus: The Sherley Amendment

10-11-2014

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

Food and Drug AdministrationPharmaceuticalRegulationUnited StatesUSA

FDA oncologists welcome policy to speed approval of life-saving breast cancer drugs

FDA oncologists welcome policy to speed approval of life-saving breast cancer drugs

10-11-2014

Two key figures at the US Food and Drug Administration’s Center for Drug Evaluation and Research have…

OncologyPerjetapertuzumabPharmaceuticalRegulationRocheUSA

Highlights of EMA Pharmacovigilance unit meeting

09-11-2014

At its meeting last week, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee…

BayerBiogen IdecCSL BehringEuropeHelixateHematologyKogenateNeurologicalPharmaceuticalRegulationTecfidera

EMA PRAC’s recommendations to reduce risk of heart problems with ivabradine

09-11-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a…

AmgenCardio-vascularEuropeivabradinePharmaceuticalProcoralanRegulationServier

French regulator requests information from Roche on off-label use of Avastin for wet-AMD

French regulator requests information from Roche on off-label use of Avastin for wet-AMD

07-11-2014

The French pharma regulator, l’Agence nationale de sécurité du médicament et des produits de santé…

AvastinFranceOphthalmicsPharmaceuticalRegulationRoche

UK's NICE does not recommend Pfizer's Xiapex for Dupuytren's contracture

UK's NICE does not recommend Pfizer's Xiapex for Dupuytren's contracture

07-11-2014

The UK’s National Institute for Health and Care Excellence is consulting on provisional recommendations…

Anti-Arthritics/RheumaticsPfizerPharmaceuticalRegulationUKXiapex

FDA advisory panel votes against approval of Novartis MM drug

07-11-2014

At a meeting yesterday, the US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC)…

LBH589NovartisOncologypanobinostatPharmaceuticalRegulationUSA

Janssen’s Olysio/sofosbuvir combination cleared by FDA

Janssen’s Olysio/sofosbuvir combination cleared by FDA

06-11-2014

The Food and Drug Administration has approved US health care giant Johnson & Johnson's Olysio (simeprevir)…

Anti-viralsBiotechnologyJohnson & JohnsonMedivirOlysioRegulationsofosbuvirUSA

FDA declines approval of Macrilen, issuing CRL

06-11-2014

Canadian biopharma firm AEterna Zentaris has received a Complete Response Letter from the US Food and…

Aeterna ZentarisMacrilenMetabolicsPharmaceuticalRegulationUSA

Eisai “dismayed” by G-BA decision on Fycompa

06-11-2014

Japanese drug major Eisai has expressed “utmost disappointment” that the German Federal Joint Committee…

EisaiFycompaGermanyNeurologicalPharmaceuticalPricingRegulation

Sarepta will rebound strongly from eteplirsen US delay, says analyst

06-11-2014

US rare and infectious disease specialist Sarepta Therapeutics remains a strong contender in the Duchenne…

eteplirsenNeurologicalPharmaceuticalRare diseasesRegulationSarepta TherapeuticsUSA

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