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FDA

Showing 15 posts of 1442 posts found.

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FDA approves single monthly injection of Amgen’s Repatha

July 12, 2016
Manufacturing and Production, Sales and Marketing Amgen, FDA, Repatha, pushtronex

Amgen (NASDAQ: AMGN) has announced that the US Food and Drug Administration (FDA) has approved a new, monthly single-dose administration …

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shire_image_4

Shire dry eye treatment gets FDA approval

July 12, 2016
Manufacturing and Production, Sales and Marketing FDA, Shire, dry eye, xiidra

Shire (LSE: SHP) has announced that the US Food and Drug Administration has approved its twice-daily eye drop solution, Xiidra …

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amgen_hq

Amgen’s Humira biosimilar candidate “highly similar” to originator, says FDA

July 8, 2016
Research and Development, Sales and Marketing ABP-501, AbbVie, Amgen, FDA, Humira, abp 501, biosimilar

A report from a meeting of the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee has concluded that Amgen’s …

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chemo-web

FDA suspends Juno Therapeutics cancer drug trial after patient deaths

July 8, 2016
Medical Communications, Research and Development FDA, juno therapeutics, patient deaths

Juno Therapeutics (NASDAQ: JUNO) has had its Phase II trial investigating JCAR015 in adult patients with relapsed or refractory B …

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fda_sign_web

FDA issues new guidance on next generation sequencing

July 7, 2016
Medical Communications, Research and Development FDA, next generation sequencing, precision medicines initiative

The US Food and Drug Administration (FDA) has issued new draft guidance, as part of the Precision Medicine Initiative, on …

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pfizer_enbrel

New data shows Sandoz’s Enbrel biosimilar has equivalent efficacy profile

July 7, 2016
Research and Development, Sales and Marketing Amgen, EMA, Enbrel, FDA, Novartis, Sandoz, biosimilars

Sandoz has announced new data confirming the equivalent safety and efficacy profile of their biosimilar version of Enbrel (etanercept) in …

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Bristol-Myers Squibb’s Opdivo gets US FDA breakthrough therapy designation for advanced bladder cancer

June 28, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Breakthrough Therapy Designation, Bristol-Myers Squibb, FDA, bladder cancer, opdivo, regulation

Bristol-Myers Squibb (NYSE:BMY) said the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to its immunotherapy Opdivo for the …

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allergan

FDA approves expanded label for Allergan’s Avycaz

June 24, 2016
Medical Communications, Research and Development, Sales and Marketing Allergan, Avycaz, FDA, expanded label

Allergan (NYSE: FDA) has announced that the US Food and Drug Administration (FDA) has approved its supplemental new drug application …

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clinical_trial_3

Wave Life Sciences granted FDA orphan drug designation for Huntington’s disease drug

June 22, 2016
Research and Development FDA, drug, huntington's disease, wave life sciences

Wave Life Sciences (NASDAQ: WVE) has announced that it has received orphan drug designation for the US Food and Drug …

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Chiasma cuts staff by 33% after FDA rejects rare disease drug, Mycapssa

June 16, 2016
Research and Development, Sales and Marketing FDA, chiasma, cutbacks, failure, workforce cuts

US-based biopharmaceutical company, Chiasma (NASDAQ: CHMA), has announced substantial job cuts as it attempts to restructure following the US Food …

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trials

Marathon Pharma submits application for Duchenne muscular dystrophy drug to FDA

June 15, 2016
Research and Development, Sales and Marketing FDA, duchenne, marathon pharmaceuticals

Marathon Pharmaceuticals has announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration …

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FDA issues warnings on Janssen, AstraZeneca diabetes drugs

June 15, 2016
Research and Development, Sales and Marketing AstraZeneca, FDA, Janssen, farxiga, invokana

The US Food and Drug Administration has issued a warning of the risk of acute kidney injury for the type-2 …

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amgen_flag

FDA to review data on Amgen’s Humira biosimilar

June 14, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Amgen, FDA, Humira, biosimilar

Amgen (NASDAQ: AMGN) has announced the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee will review data supporting the …

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FDA committee recommends MSD’s c. diff prevention drug

June 10, 2016
Medical Communications, Research and Development, Sales and Marketing FDA, MSD, Merck, bezlotoxumab, committee, zinplava

The US Food and Drug Administration’s (FDA) antimicrobial drugs advisory committee has voted by 10 to 5, with one abstention, …

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FDA targets online illegal prescription drugs sellers

June 10, 2016
Medical Communications, Sales and Marketing FDA, Ireland, illegal drug sales

The US Food and Drug Administration (FDA), in partnership with an INTERPOL-led global collaborative effort, has announced that it has …

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