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approval

Showing 15 posts of 40 posts found.

AbbVie and Janssen announce failure of cancer drug Imbruvica in Phase 3 trial

July 12, 2018
Research and Development AbbVie, Cancer, FDA, Janssen, approval

AbbVie and Janssen have announced that Imbruvica (ibrutinib) failed to achieve the primary endpoint in a late-stage study assessing its …

News
nice_reception_small_size

Insider interview: NICE discusses its planned ‘fast-track’ appraisal process

December 19, 2016
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing NHS, NICE, UK, approval

Jenniffer Prescott, associate director of planning, operations and topic selection, answers questions on NICE’s recent plans for a ‘fast-track’ appraisal …

Feature
bms

European Commission approves new RA treatment from BMS

September 6, 2016
Research and Development, Sales and Marketing BMS, Bristol-Myers Squibb, EMA, EU, Orencia, RA, abatacept, approval, rheumatoid arthritis

Bristol-Myers Squibb has received approval from the European Commission for rheumatoid arthritis (RA) treatment Orencia (abatacept), making it the first …

News

NICE recommends Bayer’s Xofigo for prostate cancer treatment

September 2, 2016
Medical Communications, Sales and Marketing Bayer, NICE, approval, prostate cancer, recommendation, xofigo

NICE has issued final draft guidance recommending Bayer’s Xofigo (radium-223 dichloride) for the treatment of prostate cancer. Previously, the drug …

News

FDA approves Pfizer’s abuse-deterrent opioid painkiller

August 22, 2016
Sales and Marketing FDA, Pfizer, abuse deterrent, abuse-deterrent, approval, opioid, troxyca

Pfizer has announced that the US FDA has approved Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules for the …

News
teva_copy

EU grants marketing authorisation for Teva’s asthma drug Cinqaero

August 19, 2016
Medical Communications, Sales and Marketing EU, Teva, approval, asthma, cinqaero, eosinophilic

The European Commission has granted marketing authorisation for Teva’s Cinqaero (reslizumab), as an odd-on therapy in adult patients with severe …

News
merck_incweb

MSD scores EU approval for Keytruda in lung cancer

August 3, 2016
Research and Development, Sales and Marketing EU, MSD, Merck, approval, keytruda, lung cancer

MSD, called Merck in the US and Canada, has announced that the European Commission has approved Keytruda (pembrolizumab) for patients …

News
sanofi_hq__boetie_hall

Sanofi gets FDA approval for type-2 diabetes treatment Adlyxin

July 28, 2016
Research and Development, Sales and Marketing FDA, Lixisenatide, Lyxumia, Sanofi, adlyxin, approval, diabetes, type 2, type-2, zealand

Sanofi has announced that the US Food and Drug Administration (FDA) has approved Adlyxin (lixisenatide), which is a once-daily mealtime …

News

Pfizer gets approval expansion from FDA for pneumonia vaccine

July 13, 2016
Research and Development, Sales and Marketing FDA, Pfizer, Prevnar 13, adults, approval

The US Food and Drug Administration (FDA) has issued an expanded approval for Pfizer’s pneumococcal pneumonia vaccine Prevnar 13 to …

News
allergan

FDA approves Allergan hypertension fixed-dose combo, Byvalson

June 7, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Allergan, FDA, US, angiotensin ii, approval, beta blocker, byvalson, hypertension, nebivolol, valsartan

Allergan has announced that the US Food and Drug Administration (FDA) has approved its fixed-dose combination, Byvalson (nebivolol and valsartan), …

News
lab

Shares at Sarepta Therapeutics jump after FDA delay in drug approval review

May 26, 2016
Research and Development, Sales and Marketing Duchenne Muscular Dystrophy, FDA, Sarepta Therapeutics, approval, delay, delayed announcement, muscular dystrophy, sarepta, treatment

Sarepta Therapeutics (NASDAQ: SRPT) has witnessed a sharp rise in the price of its shares after the US Food and …

News

NICE recommends Jevtana for advanced prostate cancer

May 25, 2016
Sales and Marketing Jevtana, NICE, approval, prostate cancer, recommendation

The National Institute for Health and Care Excellence (NICE) has recommended Sanofi Genzyme’s Jevtana (cabazitaxel), in combination with prednisone or …

News
lab

EU approves Idelvion for haemophilia B treatment

May 13, 2016
Medical Communications, Research and Development CSL, EU, Idelvion, approval, haemophilia B

The European Commission has approved Idelvion, coagulation Factor IX (recombinant) for the treatment and prophylaxis of bleeding in patients with …

News

Multiple myeloma treatment from BMS and AbbVie scores EU approval

May 12, 2016
Research and Development, Sales and Marketing AbbVie, BMS, EMA, EU, Empliciti, approval, bristl-myers squibb, elotuzumab, multiple myeloma

Bristol-Myers Squibb (NYSE: BMY) and AbbVie (NYSE: ABBV) have announced that the European Commission has approved Empliciti (elotuzumab) for the …

News
gilead-sciences

EU grants approval for Gilead’s HIV treatment Descovy

April 26, 2016
Manufacturing and Production, Research and Development EU, HIV, approval, descovy, taf

Gilead Sciences (NASDAQ: GILD) has announced that the fixed-dose combination HIV treatment, Descovy (emtricitabine, tenofovir alafenamide), has been granted marketing …

News
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