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US FDA

Showing 15 posts of 44 posts found.

sobi

Sobi says US FDA approves higher dose of Orfadin to treat rare genetic disorder

June 15, 2016
Research and Development, Sales and Marketing US FDA, genetic disorder, regulation, sobi

Swedish Orphan Biovitrum AB (Sobi) on Wednesday said the US Food and Drug Administration (FDA) has approved a higher strength …

News
shire_image_4

Shire gets FDA breakthrough therapy designation for two rare disease drugs

June 13, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Breakthrough Therapy Designation, Shire, US FDA, rare disease, rare disease drugs

Ireland headquartered Shire (LSE: SHP) on Monday said the US Food and Drug Administration (FDA) has granted breakthrough therapy designation …

News
teva_copy

FDA asks Teva for further study on Huntington drug candidate

June 1, 2016
Medical Communications, Research and Development Huntington disease, Teva, US FDA, regulation

Israel-based Teva Pharmaceutical Industries (NYSE: TEVA) said the US regulators have put on hold the approval for its drug to …

News

AstraZeneca says NDA for drug to treat hyperkalaemia gets observations from the US FDA

May 27, 2016
Medical Communications, Research and Development AstraZeneca, NDA, US FDA, regulation

UK pharma firm AstraZeneca (LSE: AZN) on Friday said the US Food and Drug Administration (FDA) has issued a complete …

News

US FDA advisors question usefulness of Sanofi’s combination diabetes therapy

May 24, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Sanofi, US FDA, diabetes, drug trial, regulation

US Food and Drug Administration staff questioned the benefits of French drugmaker Sanofi’s (Euronext: SAN) diabetes drug candidate as well …

News
azhqlondonweb

AstraZeneca says its trial drug for thyroid cancer granted US FDA orphan drug designation

May 12, 2016
Research and Development, Sales and Marketing AstraZeneca, Orphan Drug Designation, US FDA, drug trial, regulation

AstraZeneca (LSE: AZN) on Thursday said the US Food and Drug Administration (FDA) has granted Orphan Drug Designation its trial …

News
2174264_eisai_logo-web

Eisai says European Commission backs Halaven to treat of advanced Liposarcoma in Europe

May 5, 2016
Research and Development, Sales and Marketing EC, Eisai, US FDA, oncology, regulation, soft tissue sarcoma

The European Commission has backed marketing for the Japanese drug major Eisai’s (TYO: 4523) Halaven (eribulin) to treat advanced soft …

News
headquarters_3_web

Eli Lilly’s cancer drug candidate scores FDA priority review

May 5, 2016
Eli Lilly, US FDA, oncology, regulation

US drugmaker Eli Lilly (NYSE: LLY) said the US Food and Drug Administration (FDA) has granted priority review for its …

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novartis_outside_1

Novartis’ Ilaris gets US FDA breakthrough therapy designation to treat fever syndromes

April 27, 2016
Business Services, Research and Development Breakthrough Therapy Designation, Novartis, US FDA, periodic fever syndromes

Novartis (VTX: NOVN) on Wednesday said its drug to treat three rare types of periodic fever syndromes has been granted …

News
clinicaltrial1

US panel says Sarepta’s trial DMD drug not proven effective

April 26, 2016
Manufacturing and Production, Research and Development DMD, US FDA, drug trial, sarepta

A US advisory committee has concluded Sarepta Therapeutics’ (Nasdaq: SRPT) trial drug to treat muscle wasting condition has not proved …

News
astrazeneca_building_white

AstraZeneca’s COPD therapy gets US FDA approval

April 26, 2016
Research and Development, Sales and Marketing AstraZeneca, COPD, US FDA, drug approval

UK drug firm AstraZeneca (LSE: AZN) said the US Food and Drug Administration has approved its therapy to treat chronic …

News
clinicaltrial

FDA rejects Chiasma’s new drug application for therapy to treat rare growth disorder

April 18, 2016
Research and Development, Sales and Marketing Chiasma Inc, US FDA, drug trial, rare disease

Shares in Chiasma Inc (Nasdaq: CHMA) plunged to more than halve on the Nasdaq Monday as the company reported the …

News
gilead-sciences

Gilead Sciences says Phase III trials for chronic HBV drug meet primary endpoints

April 15, 2016
Gilead Sciences, US FDA, chronic hepatitis B, drug trial

Biotech firm Gilead Sciences (NYSE: GILD) on Friday announced positive results from late-stage trials for its drug to treat chronic …

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hospital

Repros Therapeutics says positive results from Phase II trial of uterine fibroids drug; shares jump

April 15, 2016
Medical Communications, Research and Development Repros Therapeutics, Shares, US FDA, drug trial, uterine fibroids

Shares in Repros Therapeutics (Nasdaq: RPRX) surged to close over 18% Thursday after the company announced positive mid-stage trial results …

News

Merck says US FDA to review its Keytruda for head & neck cancer

April 14, 2016
Research and Development, Sales and Marketing Cancer Immunotherapy, Merck & Co, US FDA, keytruda

The US Food and Drug Administration has accepted Merck & Co’s (NYSE: MRK) supplemental biologics license application (sBLA) for its immunotherapy cancer …

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