The U.S. Food and Drug Administration is taking steps towards requiring electronic submission of certain safety reports for products being evaluated by the FDA under an investigational new drug (IND) application into the FDA's Adverse Event Reporting System (FAERS).
Terns Pharmaceuticals, Inc., a global biopharmaceutical company focused on discovering and developing innovative therapies to treat non-alcoholic steatohepatitis (NASH) and cancer, recently announced that TERN-101, an investigational farnesoid X receptor (FXR) agonist, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of NASH.
Bayer, a leader in women's healthcare, announced today the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) to potentially extend the duration of use for its market leading1 intrauterine device (IUD) Mirena® (levonorgestrel-releasing intrauterine system) 52 mg
AVROBIO, Inc. (the “Company”), recently announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation for the Company’s investigational gene therapy, AVR-RD-02, for the treatment of Gaucher disease
Oblique Therapeutics AB announces that Sreesha P Srinivasa is on the list of invited speakers who will be presenting at the RAS- Targeted Drug Discovery Europe Summit in Vienna in February 2020
Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company focused on the development and commercialization of novel antibiotics to treat serious bacterial infections, today announced the U.S. Food and Drug Administration (FDA) has approved BAXDELA® (delafloxacin) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria
Parents of children affected by Phelan-McDermid syndrome (PMS) announce the formation of CureSHANK, a nonprofit organization to accelerate drug development in PMS and other diseases related to the SHANK genes
Evotec SE recently announced the inauguration of LAB555, an academic BRIDGE partnership with Integra Holdings and Yissum, the Technology Transfer Company of the Hebrew University of Jerusalem
AptarGroup, Inc., a global leader in consumer dispensing, active packaging and drug delivery solutions, recently announced that its Activ-Blister packaging solution for oral solid dose drug delivery was recently approved by the U.S. Food and Drug Administration (FDA) for a HIV prevention medicine
Bicycle Therapeutics plc, a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, recently announced that it will collaborate with Oxford University’s Oxford Drug Discovery Institute (ODDI) to use Bicycle technology for the development of novel therapeutics for dementia
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