US FDA
Sobi says US FDA approves higher dose of Orfadin to treat rare genetic disorder
June 15, 2016Research 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 …
Shire gets FDA breakthrough therapy designation for two rare disease drugs
June 13, 2016Manufacturing 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 …
FDA asks Teva for further study on Huntington drug candidate
June 1, 2016Medical 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 …
AstraZeneca says NDA for drug to treat hyperkalaemia gets observations from the US FDA
May 27, 2016Medical 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 …
US FDA advisors question usefulness of Sanofi’s combination diabetes therapy
May 24, 2016Manufacturing 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 …
AstraZeneca says its trial drug for thyroid cancer granted US FDA orphan drug designation
May 12, 2016Research 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 …
Eisai says European Commission backs Halaven to treat of advanced Liposarcoma in Europe
May 5, 2016Research 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 …
Eli Lilly’s cancer drug candidate scores FDA priority review
May 5, 2016Eli 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 …
Novartis’ Ilaris gets US FDA breakthrough therapy designation to treat fever syndromes
April 27, 2016Business 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 …
US panel says Sarepta’s trial DMD drug not proven effective
April 26, 2016Manufacturing 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 …
AstraZeneca’s COPD therapy gets US FDA approval
April 26, 2016Research 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 …
FDA rejects Chiasma’s new drug application for therapy to treat rare growth disorder
April 18, 2016Research 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 …
Gilead Sciences says Phase III trials for chronic HBV drug meet primary endpoints
April 15, 2016Gilead 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 …
Repros Therapeutics says positive results from Phase II trial of uterine fibroids drug; shares jump
April 15, 2016Medical 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 …
Merck says US FDA to review its Keytruda for head & neck cancer
April 14, 2016Research 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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