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Showing 15 posts of 1442 posts found.

novartis_building

FDA approves Novartis Enbrel biosimilar

August 31, 2016
Research and Development, Sales and Marketing Enbrel, FDA, Novartis, Sandoz, biosimilar, erzeli

Novartis, through its Sandoz division, has announced that the FDA has approved Erelzi (etanercept-szzs), a biosimilar of Amgen’s blockbuster drug …

News

Cipla receives FDA approval for generic version of Valeant antidepressant

August 30, 2016
Manufacturing and Production, Sales and Marketing Cipla, FDA, Valeant, Wellbutrin

Indian multinational pharma and biotech company Cipla has announced that its US arm InvaGen Pharmaceuticals has received approval from the …

News
chemo-web

Boost for Clovis as FDA grants priority review for rucaparib in ovarian cancer

August 25, 2016
Research and Development, Sales and Marketing FDA, clovis, ovarian cancer, rucaparib

Clovis Oncology has announced that the US Food and Drug Administration has accepted its new drug application for rucaparib, and …

News
amgen_flag

FDA says no to Amgen’s Parsabiv

August 25, 2016
Research and Development, Sales and Marketing Amgen, FDA, par

Amgen has announced that the US Food and Drug Administration (FDA) has issued a complete response letter rejecting Parsabiv (etelcalcetide) …

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fdaoutsideweb

Medical device user fees to increase 68% for 2018 to 2022

August 25, 2016
Research and Development, Sales and Marketing FDA, Medical device

The Food and Drug Administration has reached an agreement with the medical device industry and laboratory community on proposed recommendations …

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

FDA finds drug class at centre of French trial tragedy do not pose similar safety risks

August 15, 2016
Manufacturing and Production, Research and Development Bial, Biotrial, FDA, faah, rennes

The US Food and Drug Administration (FDA) has issued a statement following the results of their investigation into the recent …

News

FDA accepts Marathon’s Duchenne drug for priority review

August 11, 2016
Research and Development, Sales and Marketing Duchenne Muscular Dystrophy, FDA, deflazacort, marathon, marathon pharmaceuticals

Marathon Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted and granted a priority review for …

News
chemo-web

Heron Therapeutics gets FDA approval for chemotherapy-induced nausea drug

August 11, 2016
Research and Development, Sales and Marketing FDA, chemotherapy-induced nausea, granisetron, heron therapeutics, sustol

Heron Therapeutics has announced that it has received US Food and Drug Administration (FDA) approval for Sustol (granisetron) for the …

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merckincweb2

FDA approves MSD’s Keytruda for head and neck cancer treatment

August 8, 2016
Manufacturing and Production, Research and Development Cancer, FDA, MSD, keytruda

The US Food and Drug Administration (FDA) has approved MSD’s Keytruda (pembrolizumab) for treatment of recurrent or metastatic head and …

News
humira_abbott_

AbbVie files lawsuit against Amgen over Humira copy

August 8, 2016
Research and Development, Sales and Marketing AbbVie, Amgen, FDA, Humira, rheumatoid arthritis

Abbvie has filed a patent infringement lawsuit against Amgen over the latter firm’s copy of its Humira (adalimumab) rheumatoid arthritis …

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merck_and_co

MSD files Lantus biosimilar with FDA

August 8, 2016
Sales and Marketing FDA, Lantus, MK-1293, MSD, application, biosimilar

MSD, known as Merck in the US and Canada, has filed a new drug application with the US Food and …

News
fda2outsideweb

FDA determines Xiamen Origin Biotech wilfully lied to inspectors and customers

August 4, 2016
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Xiamen Origin Biotech

The US Food and Drug Administration (FDA) carried out an inspection of Chinese drug manufacturer  Xiamen Origin Biotech, finding the …

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novartis_building

Breakthrough therapy designation for Novartis in advanced breast cancer treatment

August 3, 2016
Research and Development, Sales and Marketing Breakthrough Therapy Designation, FDA, LEE011, Novartis, ribociclib

Novartis has announced that the US Food and Drug Administration (FDA) has granted a breakthrough therapy designation to LEE011 (ribociclib) …

News

FDA approves Shire’s haemophilia A treatment system

August 1, 2016
Manufacturing and Production, Research and Development FDA, Shire, adynovate, baxject, haemophilia

Shire has announced that the Food and Drug Administration (FDA) has approved the baxject III reconstitution system for adynovate [antihemophilic …

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