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US FDA approves Mylan’s copy of Allergan’s vaginal cream expressbpd
January 03, 2018
Vaginal atrophy results in thinning and inflammation of the vaginal walls due to less estrogen
Some of FDA’s Major Policy Goals For 2018 americanpharmaceuticalreview
January 02, 2018
Twice a year the federal government publishes the “Unified Agenda of Federal Regulatory and Deregulatory Actions”, which provides the American public with insight into regulations under development or review throughout the federal government.
Surprise! FDA Clears Launch For Portola's Potential Multibillion-Dollar Drug Next Month biospace
December 22, 2017
FDA continues to hand out some early Christmas presents to pharma companies. This week, Portola Pharmaceuticals said the agency approved its Prior Approval Supplement (PAS) for Bevyxxa (betrixaban) ahead of its scheduled Jan. 30, 2018 action date.
Inventor of the First FDA-Approved Defibrillator to Give Keynote Address at 23rd Annual Medical Tech prnasia
December 07, 2017
Frost & Sullivan is pleased to announce that Mir Imran, Chairman and Chief Executive Officer, InCube Labs, Incorporated, will be the recipient of the Innovation Award at the 23rd Annual Medical Technologies: A Frost & Sullivan Executive MindXchange
US FDA grants fast-track status to Stealth’s elamipretide pharmaceutical-technology
November 30, 2017
The US Food and Drug Administration (FDA) has granted fast-track designation for Stealth BioTherapeutics’ lead candidate, elamipretide, to treat patients with Barth syndrome.
Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to address impact of IV fluid shortag fda
November 20, 2017
Update on the efforts by the FDA to address IV fluid shortages exacerbated by Hurricane Maria and advice for hospitals in managing the shortage
Allergan Receives FDA Approval for Use of VRAYLAR in Schizophrenia Treatment americanpharmaceuticacreview
November 14, 2017
Allergan announced the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for VRAYLAR (cariprazine) for the maintenance treatment of adults with schizophrenia.
Merck Receives FDA Approval for GONAL-f Prefilled Pen americanpharmaceuticacreview
November 14, 2017
Merck announced that the company received approval for a new version of GONAL-f (follitropin alfa injection) prefilled pen from the U.S.
Heron takes on Merck's Emend with FDA win for antinausea drug Cinvanti fiercepharma
November 13, 2017
Merck’s drug for chemo-induced nausea and vomiting has some new competition.
Sunovion Announces FDA Acceptance for NDA Review of Dasotraline americanpharmaceuticacreview
November 13, 2017
The NDA submission is supported by multiple placebo-controlled safety and efficacy studies, as well as two long-term studies that assessed the safety of dasotraline in people with ADHD for up to one year.

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