Regulation

Filter

Current filters:

None

Popular Filters

2276 to 2300 of 2738 results

Amgen's Prolia gets FDA nod for men with osteoporosis

24-09-2012

The US Food and Drug Administration last week approved a new indication for world biotech leader Amgen's…

AmgenAnti-Arthritics/RheumaticsBiotechnologyMen's HealthNorth AmericaProliaRegulation

Boehringer Ingelheim files first oncology compound, afatinib, for EU approval

21-09-2012

German family-owned drug major Boehringer Ingelheim said yesterday that it has submitted a Marketing…

afatinibBoehringer IngelheimEuropeOncologyPharmaceuticalRegulation

Chugai pushed into filing for Avastin glioblastoma indication in Japan

21-09-2012

Japanese drugmaker Chugai Pharmaceutical (TYO: 4519), which is majority-owned by Swiss drug major Roche…

Asia-PacificAvastinChugai PharmaceuticalOncologyPharmaceuticalRegulationRoche

Bayer files for EU approval of low-dose contraceptive patch

21-09-2012

German drug major Bayer (BAYN: DE) yesterday submitted an application for marketing authorization in…

BayerethinylestradiolEuropegestodenePharmaceuticalRegulationReproductiveWomen's Health

Legislative fix would allow FDA to collect GDUFA user fees

20-09-2012

Legislation allowing the US Food and Drug Administration to collect several user fees under the Generic…

FinancialGenericsNorth AmericaRegulation

Red tape delaying access to new TB drug in South Africa

20-09-2012

South Africa's drug regulatory authority is placing unreasonable hurdles in the way of desperately ill…

Antibiotics and Infectious diseasesbedaquilineJohnson & JohnsonPharmaceuticalRegulationRest of the World

EMA now has more than 1,000 registered SMEs

18-09-2012

The European Medicines Agency revealed yesterday that there are, for the first time since the launch…

BiotechnologyEuropePharmaceuticalRegulation

Pharmacovigilance fees unjustifiably high, says EGA; MiEF, HAI and ISDM present alternatives

18-09-2012

The fees to be charged by the European Medicines Agency for pharmacovigilance activities as described…

EuropeFinancialGenericsPharmaceuticalRegulation

AMA backs drug labeling improvement act

17-09-2012

The American Medical Association has recently written to Representative Chris Van Hollen (Democrat, Maryland)…

GenericsNorth AmericaPharmaceuticalRegulation

FDA advisory negative on Cornerstone's lixivaptan

17-09-2012

The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) last…

BiotechnologyCardio-vascularChiesi FarmaceuticiCornerstone TherapeuticslixivaptanNorth AmericaPharmaceuticalRegulation

Alzheimer's disease: From setbacks to stepping stones

16-09-2012

The Pharmaceutical Research and Manufacturers of America (PhRMA) last week released two new reports at…

BiotechnologyNeurologicalNorth AmericaPharmaceuticalRegulationResearch

Small biotech and pharma companies struggling with regulatory submission timeline

13-09-2012

Some 69% of small biotech and drug companies are experiencing longer regulatory submission timelines,…

BiotechnologyNorth AmericaPharmaceuticalRegulation

FDA thumbs up for Sanofi's MS drug Aubagio

13-09-2012

As has been largely expected, the US Food and Drug Administration yesterday approved marketing of French…

AubagioBiotechnologyGenzymeNeurologicalNorth AmericaPharmaceuticalRegulationSanofi

Bayer's regorafenib gets priority review for CRC in Japan

13-09-2012

Germany's Bayer (BAYN: DE) say that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted…

Asia-PacificBayerOncologyPharmaceuticalregorafenibRegulation

US and Indian biotech industry find common ground on key issues

13-09-2012

The third annual BIO India conference kicked off yesterday in Mumbai with significant agreement among…

Asia-PacificBiotechnologyNorth AmericaPatentsRegulationResearch

FDA accepts Shire's sNDA for Vyvanse as maintenance treatment

12-09-2012

Ireland-headquartered drugmaker Shire (LSE: SHP) that the US Food and Drug Administration has accepted…

NeurologicalNorth AmericaPharmaceuticalRegulationShireVyvanse

2276 to 2300 of 2738 results

COMPANY SPOTLIGHT

Menarini

Back to top