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Allergan Receives Response Letter from FDA for Ulipristal Acetate americanpharmaceuticalreview
August 23, 2018
Allergan announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to the New Drug Application (NDA) for ulipristal acetate (UPA) for the treatment of abnormal uterine bleeding in women with uterin
COMPASS Pathways Receives FDA Approval for Psilocybin Trial americanpharmaceuticalreview
August 23, 2018
COMPASS Pathways has received approval from the US Food and Drug Administration (FDA) for a clinical trial in psilocybin therapy for treatment-resistant depression. Regulatory approvals for the trial have already been given in the UK, the Netherlands and
FDA Grants RMAT Designation to AT132 americanpharmaceuticalreview
August 22, 2018
Audentes announced the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to AT132 for the treatment of X-linked Myotubular Myopathy (XLMTM).
FDA grants orphan drug status to ASLAN’s treatment for AML biospectrumasia
August 21, 2018
ASLAN003 is an orally active, potent inhibitor of human dihydroorotate dehydrogenase (DHODH) that has the potential to be first-in-class in AML.
US FDA accepts the NDA for Motif Bio’s iclaprim for ABSSSI treatment pharmaceutical-technology
August 17, 2018
The US Food & Drug Administration (FDA) has accepted the filing of the New Drug Application (NDA) by Motif Bio for iclaprim, which is a targeted, Gram-positive investigational antibiotic, indicated for the treatment of acute bacterial skin and skin struct
FDA Approves 1st Generic EpiPen drugs
August 17, 2018
The first generic version of the EpiPen was approved by the U.S. Food and Drug Administration on Thursday, paving the way for more affordable versions of the lifesaving allergy emergency medication.
Sirnaomics Oncology IND Receives Approval from FDA americanpharmaceuticalreview
August 17, 2018
Sirnaomics announces the U.S. Food and Drug Administration (FDA) has approved the company's first oncology IND application. The IND approval will allow for the study of the company's lead product candidate, STP705, in patients with advanced cholangiocarci
FDA Approves First Generic Version of EpiPen drugs
August 17, 2018
The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pe
FDA allows use of Vertex’ Kalydeco in children aged under two pharmatimes
August 17, 2018
Use of Vertex Pharmaceuticals’ cystic fibrosis drug Kalydeco has been expanded in the US to include some children under the age of two.
FDA approves first generic EpiPen autoinjector fiercebiotech
August 17, 2018
The FDA approved the first generic versions of Mylan’s EpiPen and EpiPen Jr epinephrine autoinjectors, in a move the agency said would help increase access to the emergency treatment for allergic reactions—and is part of a broader federal mandate to help

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