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FDA

Showing 15 posts of 1442 posts found.

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Melanoma breakthrough for Merck

April 26, 2013
Research and Development, Sales and Marketing FDA, Merck, lambrolizumab, melanoma

Merck’s pipeline has been given a boost by an FDA decision to designate early-stage investigational drug lambrolizumab as a breakthrough …

News
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US nod for Tecfidera

March 28, 2013
Sales and Marketing Biogen, FDA, tecfidera

The FDA has given Biogen Idec’s oral multiple sclerosis treatment Tecfidera the green light. Earlier this week Tecfidera (dimethyl fumarate) …

News
GSK image

FDA delays GSK flu vaccine

March 27, 2013
Research and Development, Sales and Marketing FDA, GSK, Vaccine

The FDA has cooled on GlaxoSmithKline’s latest vaccine for a bird flu pandemic, Q-Pan H5N1, despite a vote of confidence …

News

Two Apotex facilities cited by FDA

March 25, 2013
Manufacturing and Production Apotex, FDA

Canadian generic drugmaker Apotex has been sent another warning letter by the FDA after violations were uncovered at two manufacturing …

News
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New AF possibility for Xarelto

March 11, 2013
Sales and Marketing Bayer, FDA, Xarelto

Bayer HealthCare is to launch a new trial of its oral blood thinner Xarelto just days after the FDA knocked …

News
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Elan sceptical of Royalty

February 26, 2013
Sales and Marketing Elan, FDA, Tysabri, royalty pharma

Elan Corporation has poured tepid water on private equity firm Royalty Pharma’s putative offer this week for the Irish biotech …

News
GSK image

FDA accepts GSK’s Anoro

February 20, 2013
Research and Development, Sales and Marketing FDA, GSK, Theravance, anoro

The FDA has accepted a New Drug Application for GlaxoSmithKline and biopharma firm Theravance’s investigational COPD drug UMEC/VI. A decision …

News
Novo Nordisk image

FDA rejects Novo diabetes drugs

February 12, 2013
Sales and Marketing FDA, Novo Nordisk, Ryzodeg, Tresiba

The FDA has knocked back two of Novo Nordisk’s diabetes drugs – just weeks after they were approved for use …

News
FDA image

FDA offers Alzheimer’s guidance

February 11, 2013
Research and Development, Sales and Marketing Alzheimer's, FDA, Roche, lilly

The FDA has issued guidance to help companies developing new treatments for patients with early-stage Alzheimer’s disease. The US regulator’s …

News
teva image

Teva plans sale of troubled Irvine plant

February 11, 2013
Manufacturing and Production FDA, Teva

Teva has decided to sell off an injectable pharmaceutical production plant in Irvine, California, that was shut down temporarily for …

News

GSK slams Guardian article

January 31, 2013
Sales and Marketing Avandia, FDA, GSK, Guardian

GlaxoSmithKline has slammed an article about its controversial diabetes treatment Avandia in The Guardian newspaper, saying that some of it …

News
Takeda HQ image

Takeda gets US diabetes approval

January 28, 2013
Sales and Marketing FDA, Nesina, Takeda, diabetes

Takeda has been given US approval for its diabetes drug Nesina and two variations on it for the treatment of …

News
FDA image

Germany’s Hameln warned by FDA over GMP failings

January 22, 2013
Manufacturing and Production FDA, GMP, Hameln

German contract manufacturer Hameln Pharmaceuticals was sent a warning letter by the FDA last month detailing a number of Good …

News
Allergan image

Botox US bladder indication

January 22, 2013
Sales and Marketing Allergan, Botox, FDA, bladder

Allergan’s Botox has been given approval by the FDA for the treatment of overactive bladder (OAB) in adults.Botox (onabotulinumtoxinA) has …

News

CHMP nod for Pfizer CML drug

January 21, 2013
Sales and Marketing CHMP, CML, FDA, Pfizer

Pfizer’s cancer drug bosutinib has been given a positive opinion by the CHMP for patients with chronic myelogenous leukemia (CML). …

News
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