FDA

Showing 15 posts of 1442 posts found.

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Three drugs put forward for EMA authorisation

March 2, 2015
Research and Development, Sales and Marketing Amgen, EMA, FDA, Novartis, Otsuka, jinarc, ristempa, zykadia

Novartis’ lung cancer drug Zykadia has been recommended for EU approval in patients previously treated with Pfizer’s Xalkori – the …

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Actavis and AZ see FDA approval for ‘superbug’ drug

February 27, 2015
Research and Development, Sales and Marketing Actavis, AstraZeneca, Avycaz, FDA, US, ceftazidime/avibactam

Actavis and AstraZeneca’s combo ‘superbug’ drug Avycaz has been shown the green light to treat patients with complicated intra-abdominal infections …

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Sanofi sees FDA approval for diabetes drug

February 26, 2015
Sales and Marketing Afrezza, FDA, Q2, Sanofi, Twitter, diabetes, insulin glargine, q4

US regulators have approved Sanofi’s diabetes treatment Toujeo which is said to be a follow-up to the French firms key …

FDA in Novartis cancer drug U-turn

February 24, 2015
Research and Development, Sales and Marketing Cancer, FDA, Farydak, Novartis, Revlimid, Velcade, myeloma

The FDA has overturned an earlier advisory committee recommendation and decided to approve Novartis’ blood cancer drug Farydak. In November …

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Priority review for Pfizer’s lung drug

February 23, 2015
Sales and Marketing FDA, Pfizer, Rapamune, lung, lymphangioleiomyomatosis, sirolimus

The US Food and Drug Administration FDA has accepted Pfizer’s lung drug Rapamune for priority review. Rapamune (sirolimus) prevents organ …

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Celgene gets FDA licence extension for myeloma drug

February 19, 2015
Sales and Marketing Celgene, FDA, Revlimid, lenalidomide, myeloma

The FDA has given Celgene an extended licence for its multiple myeloma drug Revlimid (lenalidomid), to include people who are …

fda

FDA approves Eisai thyroid drug, fast-tracks Novartis heart pill

February 16, 2015
Sales and Marketing Eisai, FDA, LCZ696, Lenvima, Novartis, heart, lenvatinib, thyroid

The FDA has approved Eisai’s thyroid cancer drug Lenvima and also granted Novartis heart pill LCZ696 a priority review.  Lenvima …

Apple watch

Apple hails health benefits of new watch

February 12, 2015
Medical Communications, Sales and Marketing Apple, FDA, cook, healthkit, watch, wearables

Users of the upcoming Apple Watch will be prompted to be more active because ‘sitting is the new cancer’ according …

US measles outbreak worst for 15 years

February 11, 2015
Sales and Marketing FDA, cdcp, hamburg, measles, priorix, trimovax, vaccines

The worst measles outbreak in 15 years has reached a startling 121 cases in the US alone according to the …

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FDA clears Roche eye drug

February 9, 2015
Sales and Marketing AMD, DME, FDA, Lucentis, Retina, Roche, eyes, ranibizumab

The US Food and Drug Administration has shown Roche’s eye-condition drug Lucentis the green light to treat patients with diabetic …

FDA commissioner steps down in March

February 5, 2015
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Andrew von Eschenbach, FDA, Margaret Hamburg, Obama, Stephen Ostroff, US

The commissioner of the US Food and Drug Administration Dr Margaret Hamburg is to resign from her post at the …

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Pharma adverse event FDA reports are inadequate

February 5, 2015
Sales and Marketing FDA, Gilead, Solvaldi, US Institute for Safe Medication Practices, pharma, sofosbuvir

Reports of adverse drug events submitted to the FDA by pharma firms are often incomplete and lacking in detail, a …

Pfizer gets early approval for breast cancer drug

February 4, 2015
Sales and Marketing FDA, Pfizer, Xalkori (crizotinib), axitinib, bosulif, bosutinib, femara, ibrance, inlyta, letrozole, palbociclib

The FDA has shown Pfizer’s breast cancer drug Ibrance an early green light to treat patients who are at the …

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Merck releases insomnia drug in US

February 4, 2015
Sales and Marketing FDA, Merck, belsomra, insomnia, orexin, suvorexant

Merck’s insomnia drug Belsomra is now available in the US to treat patients who have difficulty falling asleep or staying …

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Mylan buys into women’s health

February 3, 2015
Sales and Marketing Abbott, FDA, India, Mylan, famy care, female, women

Mylan is to acquire a number of women’s healthcare companies from Indian-based Famy Care that will build upon its 2008 …

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