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approval

Showing 10 posts of 40 posts found.

opdivo_1

Bristol-Myers Squibb cancer immunotherapy Opdivo approved in EU

April 13, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Bristol-Myers Squibb, Cancer, EU, NICE, approval, immunotherapy, opdivo

Bristol-Myers Squibb has announced that its potentially life-extending cancer immunotherapy, Opdivo (nivolumab), has been approved by the European Commission to …

News

Novartis receives EU approval for blood disorder treatment in children

April 7, 2016
Research and Development, Sales and Marketing EMA, EU, ITP, Novartis, Revolade, approval, blood disorder, children, chronic itp

Novartis (NYSE: NVS) has announced that Revolade (eltrombopag) has been approved in the EU for use in paediatric patients aged …

News

EMA to review Pfizer’s Xeljanz for patients with rheumatoid arthritis

March 24, 2016
Research and Development, Sales and Marketing EMA, Pfizer, Xeljanz, approval, authorisation, marketing, review, rheumatoid arthritis

Pfizer (NYSE: PFE) has announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application (MAA) …

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teva_copy

Teva announces FDA approval for asthma injection, Cinqair

March 24, 2016
Research and Development, Sales and Marketing FDA, Teva, approval, asthma, cinqair

The US Food and Drug Administration has approved Cinqair (reslizumab), an injection for patients with severe asthma developed by Teva …

News
novartissunlight_copy

Novartis’s heart failure drug given final recommendation by NICE

March 21, 2016
Manufacturing and Production, Research and Development Entresto, NICE, Novartis, approval, draft, guidance, heart failure, heart failure drug

The National Institute for Health and Care Excellence (NICE) has issued its final guidance on Entresto (sacubritil/valsartan), a heart failure …

News
abraxane0058

Wales approve pancreatic cancer drug for use despite NICE rejection in England

March 18, 2016
Medical Communications, Research and Development Abraxane, Celgene, England, NHS, NICE, Wales, approval

Celgene (Nasdaq: CELG) has announced that Abraxane, in combination with gemcitabine, will continue to be an available treatment option for …

News
breckenridge_pharma

FDA approves Breckenridge’s generic of Pfizer’s anti-epilepsy drug

March 18, 2016
Research and Development, Sales and Marketing FDA, Neurontin, Pfizer, anti-epilepsy, approval, breckenridge, gabapentin, tris pharma

Breckenridge Pharmaceutical Inc. has announced that their generic of Pfizer’s anti-epilepsy drug Neurontin (gabapentin) has been approved by the US …

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bayercross3

FDA approves Bayer haemophilia A drug Kovaltry

March 17, 2016
Research and Development, Sales and Marketing Bayer, FDA, approval, drug, drug approval, haemophilia, haemophilia a, kovaltry, viii compound

Bayer (ETR:BAYN) has received approval from the US Food and Drug Administration (FDA) for Kovaltry (octocog alfa), an unmodified, full-length …

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teva_copy

Teva suffers EpiPen generic setback after FDA rejection

March 4, 2016
Medical Communications, Research and Development FDA, Teva, analphylaxis, approval, auto injector, auto-injector, rejection

The release of Teva Pharmaceuticals generic for the anaphylaxis treatment, EpiPen (epinephrine), is now expected to be severely delayed after …

News
Lucentis image

Lucentis gains new licence in the US

August 13, 2012
Sales and Marketing Eylea, FDA, Lucentis, approval, avastin, wet AMD

Roche’s eye drug Lucentis has gained a new licence in the US to treat diabetic macular oedema. The FDA has …

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