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FDA

Showing 15 posts of 1444 posts found.

Perjeta image

Perjeta becomes first approved drug for early breast cancer

October 1, 2013
Sales and Marketing FDA, Herceptin, Perjeta, Roche

Roche’s Perjeta has become the first preoperative breast cancer drug to be authorised by the FDA after it was granted …

News
EMA building

The future of data disclosure in Europe

September 30, 2013
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, FDA, GSK, transparency

The debate of clinical trial transparency has at times appeared a peculiarly British issue, but plans are afoot in Europe …

Feature
merck_entrance

MSD’s sugammadex knocked back by FDA – again

September 25, 2013
Research and Development, Sales and Marketing FDA, MSD, Merck, Sugammedex

News

FDA: we won’t regulate most apps

September 24, 2013
Medical Communications, Sales and Marketing FDA, apps, iphone

News
Twitter iPhone

FDA spends big on social media outlook

September 20, 2013
Medical Communications, Sales and Marketing FDA, Facebook, PMCPA, Psoriasis 360, Twitter

News

BI leukaemia drug gains FDA breakthrough status

September 18, 2013
Research and Development, Sales and Marketing Boehringer Ingelheim, FDA, acute myeloid leukaemia, breakthrough status

News
bowel_cancer_screening

FDA approves first generic Xeloda

September 17, 2013
Sales and Marketing FDA, Roche, Teva, Xeolda, breast cancer, colorectal cancer

News
Sanofi image

Sanofi withdraws lixisenatide US application

September 12, 2013
Sales and Marketing FDA, Lixisenatide, Sanofi, diabetes, elixa

In a blow to its diabetes pipeline, Sanofi has withdrawn a new drug application (NDA) for lixisenatide in the US …

News
EMA image

Regulators produce QbD report

August 28, 2013
Manufacturing and Production, Sales and Marketing EMA, FDA, QbD

European and US regulators have published the first fruits of their collaboration on assessing measures to ensure drugs are manufactured …

News

FDA warns Fresenius Kabi over plant problems

August 27, 2013
Manufacturing and Production FDA, Fresenius, kabi, recall

German drugmaker Fresenius has been sent another warning letter by the US Food and Drug Administration, this time for a …

News
fda_sign_web

Doctor questions FDA’s diet drug approvals

August 23, 2013
Research and Development, Sales and Marketing BMJ, Belviq, EMA, FDA, Vivus, diet pills, obesity

News
novartis_window

Novartis muscle drug granted ‘breakthrough’ FDA status

August 21, 2013
Research and Development, Sales and Marketing FDA, Novartis, bimagrumab, breakthrough status, sIBM

News
GSK image

HIV pill Tivicay gains FDA approval

August 14, 2013
Sales and Marketing FDA, GSK, Tivicay, ViiV

ViiV and partner GlaxoSmithKline’s new HIV drug Tivicay has been shown the FDA’s green light for distribution in the US. …

News
FDA image

FDA project will examine abuse-resistant formulations

August 13, 2013
Manufacturing and Production API, CDC, FDA

The FDA is seeking tenders for a research project to examine how effective tamper-resistant formulations of opioid analgesics really are …

News
GSK image

FDA makes GSK wait

August 6, 2013
Sales and Marketing FDA, GSK, albiglutide, diabetes

The FDA is making GlaxoSmithKline wait for a verdict on the manufacturer’s investigational type 2 diabetes treatment albiglutide, extending its …

News
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