US FDA
Roche’s Venclexta gets accelerated approval from US FDA for chronic lymphocytic leukemia
April 12, 2016Manufacturing 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 …
FDA staff raises doubts on efficacy, safety of Clovis’ trial drug for lung cancer, shares plunge
April 11, 2016AstraZeneca, 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 …
Roche’s cancer immunotherapy for lung cancer gets US FDA priority review
April 11, 2016Business 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 …
US panel supports accelerated approval for Intercept’s trial drug for rare liver condition
April 8, 2016Medical 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 …
US lawmakers demand price cut for Astellas, Medivation’s prostate cancer drug Xtandi
March 30, 2016Business 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 …
Lupin drops on FDA observations; company reassures of no disruption at facility
March 29, 2016Business 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 …
GSK’s Nucala gets regulatory approval in Japan to treat bronchial asthma
March 29, 2016Manufacturing 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 …
US FDA rejects application for Eagle Pharma’s blood thinner; shares plunge
March 21, 2016Research 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 …
Celator’s shares jump on positive late-stage trials for leukaemia drug
March 16, 2016Business 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 …
GW Pharma shares more than double after positive Phase III trials for epilepsy drug
March 15, 2016Manufacturing 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 …
US FDA sets April 25 date to review Sarepta’s DMD drug, shares jump
March 11, 2016Medical 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 …
Merck says US FDA accepts its sBLA for Keytruda
March 8, 2016Manufacturing 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 …
AstraZeneca’s Faslodex gets US FDA nod in combination treatment for breast cancer
March 8, 2016Manufacturing 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 …
AbbVie’s Imbruvica gets US FDA okay as first-line treatment for CLL
March 7, 2016Sales 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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