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FDA

Showing 15 posts of 1445 posts found.

Xarelto image

FDA has Xarelto concerns

July 2, 2013
Sales and Marketing Bayer, Boehringer, FDA, Pradaxa, Xarelto

The FDA is unsure about an application to further extend the licence for Janssen and Bayer HealthCare’s blood thinner Xarelto …

News
Heparin image

FDA issues final guidance on heparin testing

June 27, 2013
Manufacturing and Production, Sales and Marketing FDA, heparin

Five years after the adulterated heparin scandal that claimed the lives of dozens of people in the US alone, the …

News

Xtandi gets EU approval

June 26, 2013
Sales and Marketing Astellas, FDA, Xtandi

Astellas Pharma’s Xtandi has been approved in the European Union for the treatment of adult men with advanced prostate cancer, …

News
Ranbaxy image

Ranbaxy facing another facility problem?

June 26, 2013
Manufacturing and Production FDA, Ranbaxy

Another facility operated by Ranbaxy Laboratories in India is reported to have failed an inspection by the FDA, potentially adding …

News
FDA Hamburg image

US gains exemption from EU requirements on API imports

June 25, 2013
Manufacturing and Production API, FDA, hamburg

The US has joined the short list of countries from which suppliers can ship active pharmaceutical ingredients into the EU …

News
Baxter image

Baxter warned by FDA over repeat failings at two plants

June 14, 2013
Manufacturing and Production FDA, baxter

Baxter has attracted the ire of the US Food and Drug Administration over quality failures at two sterile product manufacturing …

News
Impax labs image

Impax cuts staff at troubled California plant

June 11, 2013
Manufacturing and Production FDA, Impax, Rytary

US generic drugmaker Impax Laboratories has said it plans to axe a tenth of its workforce and transfer production away …

News
Novartis image

Novartis receives FDA warning

June 6, 2013
Manufacturing and Production, Sales and Marketing CGMP, FDA, GMP, Novartis

The FDA has castigated Novartis for what it calls ‘significant violations’ of current good manufacturing practice (CGMP) regulations for finished …

News

Aveo to cut workforce after FDA knock-back

June 6, 2013
Research and Development, Sales and Marketing Aveo, FDA, cuts, tivozanib

Aveo will make major jobs cuts this year after news that a kidney cancer licence for its oncology drug tivozanib …

News
fda image

FDA issues draft guidance on contract manufacturing

June 3, 2013
Manufacturing and Production FDA, GMP, Taylor

The US Food and Drug Administration FDA has published draft guidance on quality agreements between pharma companies and contract manufacturers. …

News
GSK image

FDA approves GSK cancer drugs

May 30, 2013
Sales and Marketing FDA, GSK

The FDA has approved two of GlaxoSmithKline’s cancer pills: BRAF-inhibitor Tafinlar and the first validated MEK-inhibitor, called Mekinist, both of …

News
FDA image

FDA rejects Valeant’s efinaconazole on packaging grounds

May 29, 2013
Manufacturing and Production FDA, Valeant

Valeant Pharmaceuticals has had its application to market antifungal candidate efinaconazole turned down by the FDA because of issues related …

News
Merck image

FDA experts recommend Merck sleep pill

May 24, 2013
Research and Development, Sales and Marketing FDA, Merck, insomnia, suvorexant

Merck received welcome news this week from the FDA after one of the US regulator’s expert groups voted to approve …

News

Boehringer held up by FDA for production violations

May 24, 2013
Manufacturing and Production API, Boehringer, FDA

Boehringer Ingelheim has pledged to resolve manufacturing compliance issues at a facility in Germany uncovered by the US Food and …

News
Ranbaxy image

Ranbaxy unit fined $500m for selling adulterated drugs

May 14, 2013
Manufacturing and Production FDA, GMP, Ranbaxy, fine, generics

Ranbaxy’s US subsidiary has agreed to pay fines and penalties totalling $500 million after pleading guilty to charges of manufacturing …

News
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