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Indivior secures FDA approval for Perseris to treat schizophrenia pharmaceutical-technology
August 01, 2018
Specialty pharmaceutical company Indivior has secured the US Food and Drug Administration (FDA) approval for the use of its Perseris (risperidone) to treat adults suffering from schizophrenia.
FDA rejects Insys’ opioid spray Buvaya pharmaceutical-technology
August 01, 2018
The US Food and Drug Administration (FDA) has sent a complete response letter to Insys Therapeutics rejecting its new drug application for Buvaya, a sublingual spray form of buprenorphine, an opioid analgesic.
FDA finds drugmaker using filthy kitchen utensils to produce cervical biopsy solution fiercepharma
August 01, 2018
A California drugmaker has been eviscerated in an FDA warning letter after inspectors found it using “kitchen cooking pots and household power tools” to manufacture a drug for vaginal use to stop bleeding after cervical biopsies.
FDA Warns of the Dangers of 'Vaginal Rejuvenation' drugs
August 01, 2018
Despite their growing popularity, there's no evidence that so-called "vaginal rejuvenation" procedures are either safe or effective, according to a statement released by the U.S. Food and Drug Administration.
FDA Approves Azedra for Rare Adrenal Tumors drugs
August 01, 2018
Azedra (iobenguane) has been approved by the U.S. Food and Drug Administration to treat people 12 and older with rare adrenal gland tumors (pheochromocytoma or paraganglioma) that can't be surgically removed and have spread beyond the original site.
United Therapeutics Announces FDA Approval of the Implantable System for Remodulin drugs
August 01, 2018
United Therapeutics Corporation (NASDAQ: UTHR) today announced approval by the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for the use of Remodulin (treprostinil) Injection in the Implantable System for Remodulin® (ISR).
FDA Approves Mulpleta (lusutrombopag) for Thrombocytopenia in Adults with Chronic Liver Disease drugs
August 01, 2018
The Food and Drug Administration approved lusutrombopag (Mulpleta, Shionogi Inc.) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.
Don't Believe the Hype on 'Vaginal Rejuvenation,' FDA Says drugs
July 31, 2018
Despite their growing popularity, there's no evidence that so-called "vaginal rejuvenation" procedures are either safe or effective, the U.S. Food and Drug Administration warns.
FDA finalizes guidance on integrating EHRs into clinical trials fiercebiotech
July 31, 2018
The FDA recently finalized an eagerly awaited guidance on the incorporation of electronic health records and real-world data into clinical trials and product submissions, including the use of patient medical histories.....
FDA Approves Azedra (iobenguane I 131) for Rare Adrenal Tumors drugs
July 31, 2018
The U.S. Food and Drug Administration today approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that cannot

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