Food and Drug Administration (FDA)
NEWS
Auris Medical Holding AG today announced the results of its pre-Investigational New Drug (pre-IND) meeting with the United States Food & Drug Administration (FDA), where the FDA addressed the Company’s questions and provided guidance on its AM-201 program with intranasal betahistine for the prevention of olanzapine-induced weight gain.
The U.S. Food and Drug Administration will update its review process for the approval of medical devices in the wake of a report that showed more than 80,000 injuries have been associated with medical devices for pain management since 2008.
Shares of Boston-based Zafgen, Inc. plunged more than 32 percent in pre-market trading after the company announced the U.S. Food and Drug Administration has slapped a clinical hold on its plans to launch a clinical trial in the United States for an experimental diabetes medicine due to safety concerns.
AbbVie could be eyeing another potential billion dollars of annual revenue following the accelerated approval of Venclexta for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older or who cannot tolerate intensive chemotherapy.
The company and the agency discussed the development of SYN-004 (ribaxamase) to prevent antibiotic-mediated Clostridium difficile infection (CDI).
The report, which was issued by the Council of Economic Advisors, pointed to changes in the approval process at the FDA in the approval process of generic drugs has led to greater competition in the marketplace, which has lowered the costs of the medications.
Ultragenyx Pharmaceutical Inc. today announced that it has completed a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) and plans to submit a New Drug Application (NDA) to the FDA for UX007 for the treatment of patients with long-chain fatty acid oxidation disorders (LC-FAOD) in mid-2019.
Sweden-based Sobi and Swiss-based Novimmune announced the U.S. approval of Gamifant (emapalumab-lzsg) to treat an ultra-rare disease in adults and children. Sobi’s U.S. offices are in Waltham, Mass.
YUPELRI (revefenacin) is the first and only once-daily, nebulized bronchodilator approved for the treatment of COPD in the US
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