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US FDA

Showing 14 posts of 44 posts found.

roche

Roche’s Venclexta gets accelerated approval from US FDA for chronic lymphocytic leukemia

April 12, 2016
Manufacturing and Production, Research and Development, Sales and Marketing AbbVie, Roche, US FDA, Venclexta, chronic lymphocytic leukemia

Swiss drug firm Roche (SIX: ROG) on Tuesday said the US Food and Drug Administration (FDA) has granted accelerated approval …

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cancerstudy

FDA staff raises doubts on efficacy, safety of Clovis’ trial drug for lung cancer, shares plunge

April 11, 2016
AstraZeneca, Clovis Oncology, US FDA, drug trial, lung cancer, regulation, rociletinib

Shares in Clovis Oncology Inc (Nasdaq: CLVS) plunged to close down nearly 18% after the US regulators expressed doubts if …

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roche__tree

Roche’s cancer immunotherapy for lung cancer gets US FDA priority review

April 11, 2016
Business Services, Research and Development, Sales and Marketing Roche, US FDA, atezolizumab, lung cancer

Swiss drug firm Roche (SIX: ROG) on Monday said the US Food and Drug Administration (FDA) has accepted its Biologics …

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fda2outsideweb

US panel supports accelerated approval for Intercept’s trial drug for rare liver condition

April 8, 2016
Medical Communications, Research and Development, Sales and Marketing Intercept Pharmaceuticals, PDUFA, US FDA, liver disorder, rare disease

Intercept Pharmaceuticals (Nasdaq: ICPT) said a US Food and Drug Administration (FDA) advisory committee has recommended accelerated approval for its …

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US lawmakers demand price cut for Astellas, Medivation’s prostate cancer drug Xtandi

March 30, 2016
Business Services, Manufacturing and Production, Research and Development, Sales and Marketing Astellas, Japan, Medivation, US FDA, Xtandi, drug price

US lawmakers have asked the National Institutes of Health and the Department of Health and Human Services to ‘use its …

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Lupin drops on FDA observations; company reassures of no disruption at facility

March 29, 2016
Business Services, Manufacturing and Production, Sales and Marketing Lupin, US FDA, regulation

Shares of India’s Lupin dropped over 14% Tuesday following news the US Food and Drug Administration (FDA) has made observations …

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gsk_corp_hq_brentford_2

GSK’s Nucala gets regulatory approval in Japan to treat bronchial asthma

March 29, 2016
Manufacturing and Production, Research and Development GlaxoSmithKline, Japan, Nucala, US FDA, bronchial asthma

GlaxoSmithKline (LSE: GSK) on Tuesday said the Japanese regulators have approved its drug to treat bronchial asthma.  The Japanese Ministry …

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US FDA rejects application for Eagle Pharma’s blood thinner; shares plunge

March 21, 2016
Research and Development, Sales and Marketing Eagle Pharmaceuticals, Kangio, US FDA, blood thinner

Shares in Eagle Pharmaceuticals (Nasdaq: EGRX) closed down almost 19% Friday after the US Food and Drug Administration rejected the …

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celatorpharmalogo

Celator’s shares jump on positive late-stage trials for leukaemia drug

March 16, 2016
Business Services, Research and Development, Sales and Marketing Celator Pharmaceuticals, EMA, US FDA, Vyxeos, drug trials, phase III

Shares in trial-stage Celator Pharmaceuticals (Nasdaq: CPXX) soared gaining over four times in value as the company announced late-stage trials …

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gwpharma

GW Pharma shares more than double after positive Phase III trials for epilepsy drug

March 15, 2016
Manufacturing and Production, Research and Development Epidiolex, GW Pharma, US FDA, epilepsy in children, phase III

Shares in UK-based GW Pharmaceuticals (Nasdaq: GWPH) more than doubled on the Nasdaq Monday after the company announced positive results …

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shutterstock_38078521

US FDA sets April 25 date to review Sarepta’s DMD drug, shares jump

March 11, 2016
Medical Communications, Research and Development Duchenne Muscular Dystrophy, Eteplirsen, Sarepta Therapeutics, US FDA

Shares in US-based Sarepta Therapeutics (Nasdaq: SRPT) jumped nearly 15% Thursday after the US Food and Drug Administration (FDA) said it …

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msd

Merck says US FDA accepts its sBLA for Keytruda

March 8, 2016
Manufacturing and Production, Research and Development Merck & Co, US FDA, keytruda, melanoma

US pharma giant Merck & Co said the US Food and Drug Administration (FDA) has accepted for review a new …

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astrazeneca_plaque

AstraZeneca’s Faslodex gets US FDA nod in combination treatment for breast cancer

March 8, 2016
Manufacturing and Production, Research and Development AstraZeneca, Faslodex, US FDA, palbociclib

UK drug-maker AstraZeneca said the US Food and Drug Administration (FDA) has approved a new indication expanding the use of …

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abbvie_0

AbbVie’s Imbruvica gets US FDA okay as first-line treatment for CLL

March 7, 2016
Sales and Marketing AbbVie, Janssen, Janssen Biotech, US FDA, imbruvica

Drug maker AbbVie said the US Food and Drug Administration (FDA) has approved its Imbruvica (ibrutinib) as a first-line treatment …

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