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FDA issues new guidelines for opioid use disorders meds biospectrumasia
August 08, 2018
The draft guidelines could make it easier for new treatments to be developed, as clinical trials can be based on other patient outcomes beyond reduction in drug use.
FDA Encourages Development of Treatments for Opioid Use Disorder americanpharmaceuticalreview
August 07, 2018
The U.S. Food and Drug Administration (FDA) has issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment (MAT) drugs for the treatment of opioid use disorder (OUD).
FDA Takes New Steps to Encourage the Development of Novel Medicines for the Treatment of Opioid Use Disorder drugs
August 07, 2018
The U.S. Food and Drug Administration today issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment (MAT) drugs for the treatment of opioid use disorder (OUD).
FDA chief Scott Gottlieb churns out statements by the dozen fiercepharma
August 07, 2018
When the FDA talks, pharma listens. But what happens when the FDA talks way more than usual? We're finding out now, thanks to FDA Commissioner Scott Gottlieb and his torrent of public statements.
Epizyme shuts down failing lymphoma trial as FDA imposes clinical hold pharmafile
August 06, 2018
Epizyme’s Q2 financial results have been derailed by the company’s decision to terminate further Phase 2 development of its lead drug tazemetostat in the treatment of relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL), after an interim data
FDA approves Shionogi’s Mulpleta for CLD-associated thrombocytopenia pharmaceutical-technology
August 06, 2018
The US Food and Drug Administration (FDA) has approved Japanese pharmaceutical company Shionogi’s drug Mulpleta (lusutrombopag) indicated for thrombocytopenia in adult patients with chronic liver disease (CLD) scheduled to undergo a medical procedure.
Progenics' Azedra becomes first FDA-approved treatment for adrenal tumours pharmafile
August 02, 2018
The FDA has approved its first-ever drug for rare, unresectable tumours of the adrenal gland with its decision to authorise Progenics Pharmaceuticals’ radiotherapeutic product Azedra (iobenguane I 131) in the treatment of pheochromocytoma or paraganglioma
FDA Grants Breakthrough Therapy Designation to Quizartinib fiercepharma
August 02, 2018
Daiichi Sankyo announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to quizartinib, an investigational FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukem
FDA hits Japanese API maker with warning letter over lab data fiercepharma
August 02, 2018
The FDA slapped Japanese API maker Yuki Gosei Kogyo with a warning letter, citing the Tokyo-based company for failing to report lab testing data on released lots.
FDA rejects Insys Therapeutics sublingual opioid spray pharmafile
August 01, 2018
The FDA has rejected Insys Therapeutics buprenorphine sublingual spray due to concerns about the safety of the Arizona-based company’s opioid painkiller.

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