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Showing 15 posts of 1442 posts found.

roche

FDA grants breast cancer approval to Roche’s Perjeta/Herceptin combo therapy

December 21, 2017
Sales and Marketing Cancer, FDA, Herceptin, Perjeta, Roche, breast cancer, pharma

Roche has announced that the FDA has granted approval to Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and a (Perjeta-based) …

News

Pfizer’s Bosulif scores US green light in leukaemia sub-type

December 21, 2017
Sales and Marketing FDA, Pfizer, bosulif, leukaemia, leukemia, pharma

Pfizer has revealed that its tyrosine kinase inhibitor Bosulif (bosutinib) has been awarded marketing authorisation from the FDA in the …

News

FDA approves Pfizer’s Xeljanz for psoriatic arthritis

December 18, 2017
Sales and Marketing FDA, Pfizer, Xeljanz, pharma, psoriatic arthritis

Pfizer has revealed that the FDA has passed marketing approval for Xeljanz (tofacitinib) for the treatment of active psoriatic arthritis …

News
shutterstock_159488225

Blood cancer patients over 75 are significantly underrepresented in clinical trials, study finds

December 13, 2017
Research and Development FDA, blood cancer, leukaemia, lymphoma, myeloid leukaemia, pharma

The FDA’s first comprehensive analysis of clinical trial enrolment in older patients with blood cancers has revealed that the population …

News
cocoa-174872_960_720

FDA cracks down on snortable chocolate powder

December 13, 2017
Medical Communications, Research and Development FDA, biotech, drugs, pharma, pharmaceutical

The FDA has taken action on Coco Loko and Legal Lean Syrup, both made by Arco Globus Trading LLC, after …

News
fdaoutsideweb

FDA approves first short-acting, follow-on biologic of Lilly’s Humalog insulin product

December 12, 2017
Manufacturing and Production, Sales and Marketing Admelog, FDA, Humalog, Sanofi, diabetes, insulin, pharma

The FDA has announced its approval of Sanofi’s Admelog (insulin lispro), the first follow-on biologic version of Eli Lilly’s Humalog …

News

FDA issued the fewest warnings over pharma advertising this year since 1997

December 11, 2017
Sales and Marketing Amherst, FDA, advertising, cipher, orexigen, pharma

Throughout 2017, it has emerged that the FDA has issued a record low number of warning letters to pharmaceutical firms …

News

FDA access programmes shaved up to a year off drug approval times, new study shows

December 7, 2017
Research and Development, Sales and Marketing FDA, market access, pharma

A research letter published this week has suggested that the FDA initiatives to accelerate drug approvals in the US could …

News

Akili’s video game digital treatment shows promise in ADHD, eyes FDA approval

December 4, 2017
Research and Development, Sales and Marketing ADHD, AKL-T01, Akili, FDA, pharma, video game

Akili, an unlisted affiliate of London-listed PureTech Health, has unveiled top-line results of AKL-T01, a novel digital medicine which takes …

News
fdaoutsideweb

Mylan’s Ogivri becomes first and only FDA-approved Herceptin biosimilar

December 4, 2017
Sales and Marketing Biocon, Cancer, FDA, Herceptin, Mylan, Roche, biosimilar, pharma

The FDA has announced the approval of Mylan’s Ogivri (trastuzumab-dkst), the first biosimilar version of Roche’s Herceptin to be authorised …

News
fda_building_web

Gottlieb looking to approve cancer treatments on earlier evidence

December 1, 2017
Medical Communications FDA, Scott Gottlieb, biotech, drugs, pharma, pharmaceutical

Scott Gottlieb, FDA commissioner, was speaking in front of the House Committee on Energy and Commerce, regarding the 21st Century …

News
opioid_crisis

FDA approves first and only therapy of its kind for opioid addiction

December 1, 2017
Medical Communications, Sales and Marketing FDA, Invidior, Sublocade, US, opioid crisis, opioids, pharma

Image Credit:  Marco VerchAs the US languishes in the midst of an opioid crisis which President Trump declared national emergency …

News
kardia_band

ECG Kardia Band becomes first-ever FDA-approved medical device accessory for Apple Watch

November 30, 2017
Sales and Marketing Electrocardiogram, FDA, Kardia Band, apple watch, pharma

The FDA has announced its approval of AliveCor’s Kardia Band, an electrocardiogram for use with the Apple Watch, marking the …

News
scott_gottlieb

FDA unveils guidelines to help generic medical device versions reach the market

November 28, 2017
Research and Development, Sales and Marketing FDA, Mylan, Scott Gottlieb, auto injector, auto-injector, epipen, pharma

The scandal surrounding Mylan’s price-hiking of its flagship EpiPen epinephrine auto-injector was the news of last summer, continuing to grab …

News
shutterstock_138095450

Proposed cuts to National Institutes of Health could delay up to 90% of US drug approvals

November 27, 2017
Research and Development, Sales and Marketing Donald Trump, FDA, NIH, National Institutes of Health, Trump, pharma

President Donald Trump’s budget proposes to cut funding to the National Institutes of Health by $7.2 billion or 21%. Researchers …

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