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2201 to 2225 of 2738 results

Amgen's Prolia gets FDA nod for men with osteoporosis


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


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


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


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


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


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


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


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


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


AMA backs drug labeling improvement act


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

GenericsNorth AmericaPharmaceuticalRegulation

FDA advisory negative on Cornerstone's lixivaptan


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


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


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


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


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


US and Indian biotech industry find common ground on key issues


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


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

NeurologicalNorth AmericaPharmaceuticalRegulationShireVyvanse

2201 to 2225 of 2738 results

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