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GlobeNewswire | September 12, 2023
Aquestive Therapeutics, Inc. a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced acceptance by the U.S. Food and Drug Administration (FDA) of the Company’s NDA for Libervant™ (diazepam) Buccal Film in pediatric patients between two and ...
Research
eDeviation | April 21, 2021
Ethical GmbH, a Swiss organization that provides personalized software solutions for clinical research committee management, has created a new software solution to help with protocol deviation (PD) evaluation and management. The new eDeviation® solution will allow clinical trial sponsors, CROs, and EC/IRBs to handle all protocol deviations in a single repository, assess them electronically in a blinded or unblinded manner, and track all operations. Protocol devi...
MedCity News | April 14, 2020
Interim results from a Phase III clinical trial have shown that patients receiving a cancer immunotherapy drug for a form of lung cancer on top of chemotherapy were more likely than those receiving chemotherapy alone to survive without their disease worsening, the company developing the drug said Monday. Beijing-based BeiGene reported an improvement in progression-free survival (PFS) among first-line patients with non-squamous non-small-cell lung cancer (NSCLC) receiving tislelizumab along with ...
Mayne Pharma, Mithra | June 24, 2020
Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the New Drug Application (NDA) for E4/DRSP to prevent pregnancy has been accepted for review by the US Food and Drug Administration (FDA). The FDA is expected to complete its review in the first half of calendar 2021. Developed by Mithra Pharmaceuticals SA (Mithra), E4/DRSP is a novel combined oral contraceptive pill containing 15 mg estetrol (E4) and 3 mg drospirenone (DRSP). E4 is a naturally occurring estrogen that is...
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