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Showing 15 posts of 1442 posts found.

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Regeneron’s Eylea wins FDA approval for wet age-related macular degeneration

August 20, 2018
Sales and Marketing Bayer, Eylea, FDA, Regeneron, US, pharma

Regeneron is celebrating the approval in the US of its vascular endothelial growth factor (VEGF) inhibitor Eylea (aflibercept) for the …

News

Thyroid medication recalled after Chinese supplier fails inspection

August 20, 2018
Sales and Marketing China, FDA, recall, thyroid, westminster

The Mississippi based manufacturer Westminster Pharmaceuticals is voluntarily recalling thyroid medications Levothyroxine and Liothyronine after the Chinese company Sichuan Friendly …

News
hero-plus

FDA approves first-ever generic EpiPen versions, courtesy of Teva

August 17, 2018
Medical Communications, Sales and Marketing FDA, Mylan, Teva, US, epipen, pharma

The FDA has announced the approval of the first generic versions of Mylan’s EpiPen and EpiPen Jr epinephrine auto-injectors as …

News
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FDA approves RNA therapy for rare genetic disease

August 13, 2018
Sales and Marketing FDA, Onpattro, Orphan Drugs, RNA, rare diseases

The US Food and Drug Administration has approved the RNA-based therapy Onpattro, for the treatment of the rare genetic disease …

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fdaoutsideweb

FDA approves first oral therapy for rare Fabry disease

August 13, 2018
Sales and Marketing FDA, Fabry disease, US, pharma

Amicus has revealed that its therapy Galafold (migalastat) has been awarded approval by the FDA in the treatment of adult …

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fda2outsideweb

FDA approved more generics in July than any previous month

August 10, 2018
Medical Communications FDA, generics, pharma

FDA Commissioner Scott Gottlieb took to Twitter to announce the news that the FDA smashed its previous record for number …

News
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FDA expands list of valsartan recalls

August 9, 2018
Medical Communications China, FDA, US, heart medication, recall, valsartan

The US Food and Drug Administration (FDA) has expanded a list of products containing valsartan that are to be recalled. …

News
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FDA announces policy shift to encourage new opioid addiction treatments

August 7, 2018
Manufacturing and Production FDA, deaths, opioid crisis, overdose, policy

The US Food and Drug Administration (FDA) have announced that it is altering the way it evaluates a drug’s ability …

News

Pain Therapeutics refocuses on Alzheimer’s after FDA turns down abuse-deterrent opioid painkiller

August 7, 2018
Manufacturing and Production, Research and Development, Sales and Marketing FDA, Remoxy, opioid crisis, opioids, pain therapeutics, pharma

The FDA has voted to reject Texas-based Pain Therapeutics’ abuse deterrent opioid painkiller Remoxy (oxycodone), leading the company to consider …

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Epizyme shuts down failing lymphoma trial as FDA imposes clinical hold

August 3, 2018
Medical Communications, Research and Development Epizyme, FDA, lymphoma, pharma, tazemetostat

Epizyme’s Q2 financial results have been derailed by the company’s decision to terminate further Phase 2 development of its lead …

News
US regulators FDA building

FDA rejects Insys Therapeutics sublingual opioid spray

July 31, 2018
Manufacturing and Production Crisis, FDA, insys, opioid, rejection, spray

The FDA has rejected Insys Therapeutics buprenorphine sublingual spray due to concerns about the safety of the Arizona-based company’s opioid …

News

Progenics’ Azedra becomes first FDA-approved treatment for adrenal tumours

July 31, 2018
Manufacturing and Production, Sales and Marketing Cancer, FDA, Progenics, adrenal cancer, pharma

The FDA has approved its first-ever drug for rare, unresectable tumours of the adrenal gland with its decision to authorise …

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Medicines in an automated pharmacy

EU Commission grants market authorisation for Sandoz’ Humira biosimilar

July 30, 2018
Sales and Marketing FDA, Sandoz, approval, biosimilar, european commision

The European Commission has granted marketing authorisation to Sandoz’ biosimilar Hyrimoz for use in all indications, including rheumatoid arthritis, plaque …

News

FDA approves first endometriosis pain management drug in a decade

July 25, 2018
Research and Development, Sales and Marketing AbbVie, FDA, Neurocrine Biosciences, endometriosis, pharma

The FDA has confirmed its approval of AbbVie and Neurocrine Biosciences’ Orilissa (elagolix), a nonpeptide small molecule gonadotropin-releasing hormone (GnRH) …

News
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First new treatment for reccurent malaria approved in over 60 years

July 23, 2018
Manufacturing and Production FDA, GSK, approval, malaria, p.vivax

The FDA has approved GSK’s Krintafel for the treatment of a recurring form of malaria in patients aged 16 and …

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