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Showing 15 posts of 1442 posts found.

fdaoutsideweb

Sanofi and Novo to face off in diabetes sphere following FDA approvals

November 22, 2016
Manufacturing and Production, Sales and Marketing FDA, Novo Nordisk, Sanofi, Soliqua, Xultophy, diabetes

Sanofi and Novo are set to face off in the diabetes market after the FDA approved combination treatments from the …

News
astrazeneca_building_white

AstraZeneca allowed to recruit for drug trial again

November 22, 2016
Manufacturing and Production, Research and Development AstraZeneca, FDA, clinical trial

AstraZeneca’s clinical trial for head and neck cancer had previously been put on partial hold by the FDA due to …

News

Experimental Novartis leukaemia and mastocytosis drug gets FDA Priority Review

November 14, 2016
Research and Development, Sales and Marketing FDA, Novartis, acute myeloid leukaemia

The US FDA has granted Priority Review status to Novartis’ experimental drug PKC412 (midostaurin) as a treatment for advanced systemic …

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digital_pharma

FDA clears digital sensor for GSK inhaler

November 8, 2016
Manufacturing and Production, Sales and Marketing FDA, GSK, GlaxoSmithKline, Propeller Health, ellipta

The FDA has given 510(k) clearance to a smart inhaler sensor developed by Propeller Health for use with GlaxoSmithKline’s Ellipta …

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sicorbio

Teva antihypertensive generic duo gets FDA thumbs up

November 7, 2016
Manufacturing and Production, Sales and Marketing Azor, FDA, Teva, Tribenzor

Teva has received the approval from the US Food and Drug Administration (FDA) for its generic hypertension treatments Tribenzor (olmesartan …

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fda2outsideweb

FDA issues warning letter after Chinese firm impedes investigation

November 2, 2016
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing China, FDA

The US Food and Drugs Administration (FDA) has issued a Chinese firm with a warning letter after claims it intentionally …

News

FDA rejects Sarilumab due to production facility issues

October 31, 2016
Manufacturing and Production, Sales and Marketing FDA, Regeneron, Sanofi, sarilumab

The US Food and Drugs administration has decided to reject the application for Sarilumab, Regeneron and Sanofi’s rheumatoid arthritis treatment, …

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runners-888021_960_720

Backlash over testosterone replacement drugs builds with FDA warnings

October 26, 2016
Research and Development FDA, FDA Warning, low t, prescription testosterone

The backlash against the over-prescription of ‘testosterone boosters’ continues in the US, with the FDA taking action to add clear …

News
opdivo_1

FDA accepts another Opdivo indication for priority review

October 24, 2016
Sales and Marketing BMS, Bristol-Myers Squibb, FDA, opdivo

The FDA has accepted a supplemental Biologics License Application (sBLA) for Bristol-Myers Squibb’s Opdivo for treatment of locally advanced unresectable …

News
allergan

FDA advisory committee approves of Allergan’s night-time urination medicine

October 20, 2016
Medical Communications Allergan, FDA, Night-time urination, sleep, urination

The FDA’s advisory committee ruled, in a 14-4 vote, that Allergan’s experimental nocturnal urination medication, SER120, in favour of the …

News
lilly_scientists

Eli Lilly gains accelerated approval from FDA for soft tissue sarcoma drug

October 20, 2016
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Eli Lilly, FDA, US, soft tissue sarcoma

Eli Lilly received the positive news that their drug, Lartruvo, has been granted accelerated approval for use in conjunction with …

News

Roche’s immunotherapy cancer drug given FDA approval

October 19, 2016
Research and Development Cancer, FDA, Genentech, Roche, immunotherapy, lung cancer

Coming off the back of earlier positive news this month, Roche has revealed that their drug, Tecentriq, has been given …

News
fdaoutsideweb

FDA grants $23 million to boost research on rare diseases

October 19, 2016
Research and Development Cancer, FDA, clinical trials, oncology

The FDA has continued their push to provide funding for experimental clinical trials into treatments of rare diseases. The FDA, …

News
sunpharma

Sun Pharmaceuticals hit with recall of over 31 thousand bottles of anti-depressants

October 13, 2016
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, India, US, america, sun pharmaceutical

Sun Pharmaceuticals have been forced to recall 31,762 bottles of anti-depressants from the US market after the FDA issued a …

News

Gamida Cell receives Breakthrough Therapy Designation from FDA

October 12, 2016
Research and Development Breakthrough Therapy Designation, FDA, Gamida Cell, leukaemia, lymphoma

Gamida Cell have been granted a Breakthrough Therapy Designation for their NiCord drug. NiCord has already passed through Phase I …

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