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RSS FeedPosted by Michael Wonder on 29 Sep 2019
FDA announces a new Sentinel System contract, affirming its commitment to harnessing real-world data to improve the safety and effectiveness of drugs
27 September 2019 - Today, the U.S. FDA is announcing an award granting a new five-year contract for the Sentinel ...
Posted by Michael Wonder on 28 Sep 2019
Intercept submits new drug application to the U.S. FDA for obeticholic acid in patients with fibrosis due to NASH
27 September 2019 - NDA supported by positive interim analysis results from REGENERATE Phase 3 study demonstrating OCA’s improvement of liver ...
Posted by Michael Wonder on 27 Sep 2019
FDA approves first treatment for children with rare diseases that cause inflammation of small blood vessels
27 September 2019 - The U.S. FDA today approved Rituxan (rituximab) injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis ...
Posted by Michael Wonder on 27 Sep 2019
FDA clarifies how it will regulate digital health and artificial intelligence
26 September 2019 - The FDA has issued new guidelines on how it will regulate mobile health software and products ...
Posted by Michael Wonder on 27 Sep 2019
IntelGenx announces resubmission of Rizaport new drug application
26 September 2019 - IntelGenx today announced that it has resubmitted its 505(b)(2) new drug application for Rizaport VersaFilm for the ...
Posted by Michael Wonder on 27 Sep 2019
Inventiva receives FDA fast track designation for lead asset lanifibranor in NASH
26 September 2019 - Designation is intended to facilitate the development and expedite the regulatory review of lanifibranor for the treatment ...
Posted by Michael Wonder on 26 Sep 2019
FDA begins reorganisation phase of modernisation efforts to increase efficiency and further support new drug development
26 September 2019 - Today, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) announced that the reorganization of certain ...
Posted by Michael Wonder on 26 Sep 2019
FDA approves daratumumab for transplant eligible multiple myeloma
26 September 2019 - The FDA has today approved daratumumab (Darzalex, Janssen) for adult patients with multiple myeloma in combination ...
Posted by Michael Wonder on 26 Sep 2019
FDA approves treatment for adults and children with all genotypes of hepatitis C and compensated cirrhosis that shortens duration of treatment to eight weeks
26 September 2019 - The U.S. FDA today expanded the approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight week ...
Posted by Michael Wonder on 26 Sep 2019
Ipsen announces FDA approval of Dysport (abobotulinumtoxinA) for the treatment of upper limb spasticity in children, excluding cerebral palsy
26 September 2019 - Dysport is the first and only FDA approved botulinum toxin for treatment of both paediatric upper and ...
Posted by Michael Wonder on 26 Sep 2019
Acacia Pharma announces new Barhemsys PDUFA target date of 26 February 2020
26 September 2019 - This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation ...
Posted by Michael Wonder on 25 Sep 2019
Achillion receives breakthrough therapy designation from FDA for danicopan for treatment of paroxysmal nocturnal hemoglobinuria
25 September 2019 - Achillion Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for danicopan (ACH-4471) for ...
Posted by Michael Wonder on 25 Sep 2019
FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox
24 September 2019 - The U.S. FDA announced today the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the ...
Posted by Michael Wonder on 24 Sep 2019
Aldeyra Therapeutics receives fast track designation for ADX-2191 for the prevention of proliferative vitreoretinopathy
24 September 2019 - Aldeyra Therapeutics today announced that the U.S. FDA has granted fast track designation to ADX-2191 for ...
Posted by Michael Wonder on 24 Sep 2019
Novartis unit says FDA wasn’t told of data manipulation sooner because it was ‘highly complex’
25 September 2019 - If you were wondering why Novartis waited more than three months to notify the Food and ...