Regulation

Filter

Current filters:

None

Popular Filters

2357 to 2381 of 2712 results

1,000th designation of an orphan medicinal product in EU

10-06-2012

According to a European Commission statement, over 30 million European citizens suffer from a rare disease.…

BiotechnologyEuropePharmaceuticalRare diseasesRegulation

EMA framework for conflicts of interests completed

10-06-2012

The European Medicines Agency said on Friday that its management board adopted a new "breach of trust…

EuropePharmaceuticalRegulation

FDA clears GlaxoSmithKline's Horizant for PHN

08-06-2012

The US Food and Drug Administration (FDA) has approved UK Pharma giant GlaxoSmithKline's (LSE: GSK) Horizant…

GlaxoSmithKlineHorizantNeurologicalNorth AmericaPharmaceuticalRegulationXenoPort

US FDA delays approval of Novo Nordisk's ultra-long acting insulins

08-06-2012

The US Food and Drug Administration has extended the regulatory review period for the ultra-long-acting…

DegludecDegludecPlusDiabetesNorth AmericaNovo NordiskPharmaceuticalRegulation

Boehringer Ingelheim updates US labelling of Pradaxa for stroke

07-06-2012

Independent German drug major Boehringer Ingelheim has updated the US prescribing information for Pradaxa…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulation

Alimera's Iluvien approved in Portugal

06-06-2012

Portugal's National Authority of Medicines and Health Products (Autoridade Nacional do Medicamento e…

Alimera SciencesEuropeIluvienOphthalmicsPharmaceuticalRegulation

EMA agrees more time for Vivus to prepare for Qnexa oral hearings

05-06-2012

US drug developer Vivus (Nasdaq: VVUS) says that the European Medicines Agency's Committee for Medicinal…

EuropeMetabolicsPharmaceuticalQnexaRegulationVivus

Janssen files NDA with FDA for canagliflozin in type 2 diabetes

01-06-2012

Janssen Research & Development, a subsidiary of health care giant Johnson & Johnson (NYSE: JNJ) has submitted…

canagliflozinDermatologicalsJanssenJohnson & JohnsonMitsubishi TanabeNorth AmericaPharmaceuticalRegulation

US House of Reps Passes FDA Reform Act

01-06-2012

Just days after the US Senate overwhelming approved the Food and Drug Administration Safety and Innovation…

GenericsLegalNorth AmericaPharmaceuticalPoliticsRegulation

EMA boosts EU transparency with on-line publication of suspected side effect reports

31-05-2012

The European Medicines Agency yesterday began publishing suspected side effect reports for medicines…

BiotechnologyEuropePharmaceuticalRegulation

NZ's PHARMAC consults on funding for Iressa and Tarceva

31-05-2012

The Pharmaceutical Management Agency of New Zealand, PHARMAC, is seeking feedback on a proposal to:

Asia-PacificAstraZenecaIressaOncologyPharmaceuticalPricingRegulationRocheTarceva

BioAlliance's Sitavig NDA "receivable" by US FDA

30-05-2012

French biotech firm BioAlliance Pharma (Euronext Paris: BIO) has announced the receivability of its Sitavig…

Anti-viralsBioAlliance PharmaBiotechnologyNorth AmericaRegulationSitavigSitavir

Expanded Access Program for enzalutamide agreed with US FDA

30-05-2012

The US Food and Drug Administration agreed that Medivation (Nasdaq: MDVN) and Japanese drug major Astellas…

Astellas PharmaBiotechnologyenzalutamideMDV3100MedivationNorth AmericaOncologyPharmaceuticalRegulation

US legislation could block public access to drug safety information, claim consumer groups

30-05-2012

A provision in the Food and Drug Administration Reform Act that would block public access to potentially…

BiotechnologyNorth AmericaPharmaceuticalPoliticsRegulation

Ranbaxy gains US FDA approval for Absorica

29-05-2012

India's largest drugmaker Ranbaxy Laboratories (AB: BO) has received approval from the US Food and Drug…

AbsoricaCipher PharmaceuticalsDermatologicalsIsotretinoinNorth AmericaPharmaceuticalRanbaxy LaboratoriesRegulation

UK health and life sciences group agrees new clinical trials transparency principles

28-05-2012

The Ethical Standards in Health and Life Sciences Group (ESHLSG), a partnership including the Association…

BiotechnologyEuropePharmaceuticalRegulationResearch

EMA orphan drug committee makes 16 recommendations at May meeting

28-05-2012

The European Medicines Agency's Committee for Orphan Medicinal Products (COMP) adopted a total of 16…

Alexion PharmaceuticalsBiotechnologyeculizumabEuropePharmaceuticalRare diseasesRegulation

2357 to 2381 of 2712 results

Back to top