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Showing 15 posts of 1442 posts found.

roche

FDA approves Roche skin cancer combination

November 11, 2015
Research and Development, Sales and Marketing Cotellic, FDA, Genentech, Roche, Zelboraf, cobimetinib, melanoma, skin cancer, vemurafenib

The FDA has approved the skin cancer drug Cotellic for certain forms of melanoma in combination with another Roche cancer …

News

FDA warnings create woe for Indian drugmakers

November 10, 2015
Manufacturing and Production CGMP, Dr Reddy's, Dr. Reddy's, FDA, India, Sun Pharma, manufacturing, production

Recent enforcement action has taken its toll on the fortunes of several Indian pharmaceutical manufacturers, with Sun Pharmaceuticals and Dr. …

News
China manufacturing

FDA alleges records cover-up at Chinese Pfizer plant

November 3, 2015
Manufacturing and Production FDA, Pfizer, compliance, inspection, manufacturing, production, regulations

The FDA has discovered violations at a Pfizer plant in China, including the use of out-of-date materials and record- keeping …

News
Phase III trial

FDA approves new therapy for pancreatic cancer

October 30, 2015
Medical Communications, Sales and Marketing FDA, Pancreatic cancer

The FDA has approved drug a pancreatic cancer drug, Onivyde, which has produced significant overall survival rates in an international …

News
Flemming Ornskov

Shire’s dry eye treatment gets a no – for now

October 19, 2015
Sales and Marketing Complete Response Letter, FDA, Flemming Ornskov, Shire, dry eye disease, lifitegrast

Shire has seen an application for its dry eye treatment lifitegrast rejected by the US regulator. The FDA says it …

News
BI building at night

FDA approves Boehringer’s Pradaxa reversal agent

October 19, 2015
Sales and Marketing Boehringer Ingelheim, FDA, Pradaxa, Praxbind, anticoagulant, idarucizumab

The FDA has approved Boehringer Ingelheim’s Praxbind, a reversal agent for its anticoagulant Pradaxa. The US regulator approved Praxbind (idarucizumab) …

News
onglyza

FDA rejects AstraZeneca diabetes combination

October 16, 2015
Research and Development, Sales and Marketing AstraZeneca, FDA, NDA, dapagliflozin, saxagliptin

The FDA has declined to approve AstraZeneca’s New Drug Application (NDA) for the investigational fixed-dose combination of Onglyza and and …

News
pfizer_logo

Pfizer’s Xeljanz denied plaque psoriasis indication by FDA

October 16, 2015
Research and Development, Sales and Marketing FDA, Pfizer, Xeljanj, tofacitinib

The FDA has rejected the indication expansion of Pfizer’s Xeljanz (tofacitinib) for treatment of moderate to severe cases of plaque psoriasis. …

News
cinryze_logo

Shire’s Cinryze gets FDA fast track designation

October 13, 2015
Research and Development AMR, FDA, Shire

Shire has announced that the United States Food and Drug Administration (FDA) has granted fast track designation for the investigation …

News
FDA sign

Obama’s FDA nominee criticised for big pharma ties

October 12, 2015
Sales and Marketing Bernie Sanders, Dr Robert Califf, FDA

Democratic presidential nomination candidate Senator Bernie Sanders has criticised President Obama’s choice for the next FDA commissioner, as a result …

News
akabia_logo

Akebia passes vadadustat for anaemia phase III study with FDA & EMA

October 7, 2015
Research and Development Akabia, FDA, anaemia

Akebia Therapeutics has announced the successful completion of the End-of-Phase II Meeting process with the FDA and the Scientific Advice …

News
aristada

FDA approves Alkermes schizophrenia treatment

October 6, 2015
Research and Development Alkermes, Aristada, FDA, schizophrenia

The US Food and Drug Administration (FDA) has approved Alkermes’s Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. Aristada …

News
sandoz_building

FDA accepts Sandoz submission for Amgen biosimilar

October 2, 2015
Medical Communications, Research and Development Amgen, FDA, Novartis, Sandoz, biosimilars

Sandoz, a Novartis company and a global leader in biosimilars, has announced today that the US Food and Drug Administration …

News
Sun Pharma logo

FDA withdraws approval for Sun Pharma’s epilepsy drug

September 29, 2015
Manufacturing and Production Elepsia, FDA, Sun Pharma, epilepsy, levetiracetam, manufacturing, productions, seizures

Manufacturing problems at Sun Pharma’s production site has led the FDA to revoke the company’s approval for Elepsia XR for …

News
Novo Nordisk building

FDA approves Novo Nordisk’s diabetes drugs

September 28, 2015
Sales and Marketing FDA, Novo Nordisk, Ryzodeg, Tresiba, diabetes, insulin

The FDA has approved two Novo Nordisk drugs, Tresiba and Ryzodeg, for the treatment of type 2 diabetes in adults.The …

News
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