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Dermira Receives FDA Approval for Qbrexza americanpharmaceuticalreview
July 11, 2018
Dermira announced the U.S. Food and Drug Administration (FDA) has approved Qbrexza (glycopyrronium) cloth, an anticholinergic indicated for the topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.
FDA Approves Xeomin americanpharmaceuticalreview
July 11, 2018
Merz North America announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea
FDA to Encourage More Informative Drug Labeling americanpharmaceuticalreview
July 11, 2018
The U.S. Food and Drug Administration (FDA) issued a draft guidance to provide recommendations for consideration when drafting the Indications and Usage section of human drug and biological product labeling.
Statement by FDA Commissioner on Balancing Access to Pain Treatment with Opioid Misuse americanpharmaceuticalreview
July 11, 2018
The opioid epidemic continues to take an emotional, physical and financial toll on Americans. The U.S. Food and Drug Administration is committed to taking every possible step to address the many facets of this complex public health crisis.
FDA approves Pfizer's Xeljanz for ulcerative colitis pharmatimes
July 11, 2018
The FDA has approved Pfizer's Xeljanz (tofacitinib) for the treatment of moderately to severely active ulcerative colitis.
FDA Approves IND for ADG-106 Study americanpharmaceuticalreview
July 11, 2018
Adagene has received notification from the FDA to proceed on its Investigational New Drug (IND) application to study its lead product (ADG-106) in patients with advanced solid tumors and non-Hodgkin lymphoma.
Recursion Receives FDA Clearance for REC-994 Clinical Trial americanpharmaceuticalreview
July 11, 2018
Recursion announced the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for a Phase 1 clinical trial of REC-994 in the treatment of cerebral cavernous malformation (CCM).
Pfizer files PARP inhibitor for breast cancer in US, EU pharmatimes
July 10, 2018
Regulators on both sides of the Atlantic have accepted for review Pfizer’s PARP inhibitor talazoparib as a treatment for women with a hereditary BRCA mutation.
FDA OKs MSD’s Keytruda for advanced cervical cancer pharmatimes
July 10, 2018
US regulators have given MSD’s Keytruda its first regulatory approval for a gynaecological cancer.
FDA Drops Zika Testing for Blood Donors drugs
July 10, 2018
Individual blood donations will no longer need to be tested for the Zika virus, according to the U.S. Food and Drug Administration.

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