Current Headlines

  1. Digital Submission Of Adverse Event Reports For Investigational New Drug Applications Reflects FDA’s Ongoing Modernization Efforts

    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).

  2. Terns Pharmaceuticals Receives Fast Track Designation From The FDA For TERN-101, An FXR Agonist For The Treatment Of NASH

    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.

  3. Bayer Submits Supplemental New Drug Application To FDA For Intrauterine Device (IUD) Mirena® (Levonorgestrel-Releasing Intrauterine System) 52 mg

    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

  4. AVROBIO Receives Orphan-Drug Designation From The U.S. FDA For AVR RD 02 For The Treatment Of Gaucher Disease

    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

  5. Oblique Therapeutics Will Be Presenting At The Inaugural RAS- Targeted Drug Discovery Europe Summit In Vienna In February 2020

    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

  6. Melinta Therapeutics Announces U.S. FDA Approval Of Supplemental New Drug Application For BAXDELA® (Delafloxacin) For The Treatment Of Community-Acquired Bacterial Pneumonia (CABP)

    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

  7. New Nonprofit Organization Formed To Accelerate Drug Development In Autism-Associated Genetic Conditions

    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

  8. Evotec, Integra Holdings And Yissum Establish LAB555 To Fast Track Early-Stage Drug Development

    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

  9. Aptar’s Activ-Blister Packaging Solution Approved By U.S. FDA For Oral Solid Dose HIV Prevention Medicine

    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

  10. Bicycle Therapeutics Expands Neuroscience Collaborations To Include Oxford University’s Oxford Drug Discovery Institute

    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