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Showing 15 posts of 1442 posts found.

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FDA approves Teva’s Ajovy autoinjector for treatment of migraine

January 29, 2020
Research and Development, Sales and Marketing FDA, Teva, ajovy, migraine, pharma

Israeli pharma firm Teva has revealed that the FDA has chosen to award approval to its autoinjector device for the …

News

FDA greenlights its first therapy for advanced epithelioid sarcoma population

January 27, 2020
Sales and Marketing Cancer, Epizyme, FDA, Tazverik, pharma

The FDA has revealed the approval of its first therapy for the treatment of metastatic or locally advanced epithelioid sarcoma, …

News
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FDA fast-tracks GSK’s multiple myeloma drug after priority review

January 22, 2020
Research and Development BCMA, FDA, GSK, Phase 2 Trials, Phase Trials, multiple myeloma, myeloma

The FDA has fast tracked GlaxoSmithKline (GSK) antibody drug conjugate (ADC) belantamab mafodotin, for the treatment of patients with refractory …

News
fda2outsideweb

Horizon’s Tepezza becomes first and only FDA-approved drug for thyroid eye disorder

January 22, 2020
Research and Development FDA, Horizon Therapeutics, Tepezza, pharma

Horizon Therapeutics has announced that its IGF-1R inhibitor Tepezza (teprotumumab-trbw) has become the first and only therapy approved by the …

News
fda2outsideweb

Lynparza secures accelerated FDA review for metastatic castration-resistant prostate cancer

January 20, 2020
Sales and Marketing Cancer, FDA, lynparza, pharma

Following the recommendation of the tablet formulation of the drug for use on the NHS in England and Wales, news …

News
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Top Ten most popular articles on Pharmafile.com this week

January 17, 2020
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Big Pharma, European Commission, FDA, Pakistan, Sanofi, Teva

Pakistan is cracking down on corruption and has registered cases against 200 pharmaceutical companies, while in the US the FDA …

News
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Novo’s semaglutide injection and tablets get expanded FDA approval for type 2 diabetes with established CVD

January 17, 2020
Medical Communications, Sales and Marketing FDA, Novo Nordisk, Ozempic, cardiovascular disease, diabetes, pharma

Novo Nordisk has seen label expansions approved from the FDA for both its glucagon-like peptide-1 (GLP-1) analogue injection Ozempic (once-weekly …

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FDA approves Lannett’s cocaine-based nasal spray

January 15, 2020
Research and Development FDA, Lannett, Numbrino, cocaine

It has been announced that the FDA has moved to approve Lannett Company’s Numbrino (cocaine hydrochloride) nasal solution for “the …

News

FDA approves Astellas injectable antifungal drug for newborns

January 13, 2020
Sales and Marketing Astellas, Atellas Pharma, FDA, fungal virsus

The FDA has approved the first antifungal drug to specifically treat invasive candidiasis in newborns. From Astellas, the new drug …

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Idorsia reveals it is working with Neurocrine on new epilepsy drug deal

January 10, 2020
Medical Communications FDA, Idorsia, Neurocrine, drugs, epilepsy, pharma

Idorsia revealed its 2019 deal for its investigational epilepsy medicine was with Neurocrine Biosciences, and it is potentially worth more …

News
abbottweb

FDA approves alternative approach for Abbot HeartMate 3 heart pump

January 8, 2020
Research and Development Abbott, FDA, Heart Pump, US Pharma, heart disease

The FDA announced today that it has approved a new alternative surgical technique for Abbot’s HeartMate 3 heart pump. The …

News

AstraZeneca’s drug Lokelma approved in China

January 6, 2020
Sales and Marketing AstraZeneca, China, FDA, eu commission, kidney failure, potassium

AstraZeneca’s Lokelma has been approved by the National Medical Products Administration in China. This is due to positive results based …

News
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FDA approves artificial pancreas developed by the University of Virginia

January 2, 2020
Business Services, Medical Communications FDA, Pancreas, Type 1 diabetes, diabetes, insulin, type 2 diabetes

The FDA has approved an artificial pancreas system based on technology from the University of Virginia’s Center for Diabetes Technology. …

News
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FDA fuelled opioid crisis by failing to police pharmaceutical companies, new study shows

January 2, 2020
Business Services FDA, Opioids Crisis, Opioids Trump, OxyContin, Trump Administration, opioids

The FDA’s Risk Evaluation and Mitigation Strategy (REMS), which began in 2012, failed to successfully police the companies creating opioids …

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LSD treatment for Alzheimer’s patients proves safe in recent trial

December 19, 2019
Business Services Alzheimer's, FDA, LSD, Magic mushrooms, psilocybin

The results of a Phase 1 clinical trial shows that Lysergic Acid Diethylamide (LSD) can be microdosed safely, and potentially …

News
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