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RSS FeedPosted by Michael Wonder on 11 Oct 2018
FDA approves new DNA-based test to determine blood compatibility
11 October 2018 - Test is first approved to report genotypes as final results. ...
Posted by Michael Wonder on 11 Oct 2018
FDA again approves record-breaking number of generic drugs
11 October 2018 - The FDA approved or tentatively approved a record-setting 971 generic drugs in fiscal year 2018 that ...
Posted by Michael Wonder on 08 Oct 2018
Bausch Health's Bryhali (halobetasol propionate) 0.01% lotion receives tentative FDA approval for plaque psoriasis in adults
8 October 2018 - Company plans to launch Bryhali lotion in November 2018 upon final FDA approval. ...
Posted by Michael Wonder on 08 Oct 2018
Acacia Pharma provides update on FDA regulatory review of Barhemsys
8 October 2018 - FDA issued a complete response letter to Acacia Pharma on Friday 5 October. ...
Posted by Michael Wonder on 08 Oct 2018
FDA allows marketing of first self-fitting hearing aid controlled by the user
5 October 2018 - The U.S. FDA today allowed marketing of a new device, the Bose Hearing Aid, intended to amplify ...
Posted by Michael Wonder on 08 Oct 2018
Valneva announces FDA approval of accelerated Ixiario vaccination schedule
5 October 2018 - Valneva announced today that the U.S. FDA has approved an alternate Ixiaro immunisation schedule of two doses ...
Posted by Michael Wonder on 06 Oct 2018
FDA approves Revcovi, a new enzyme replacement therapy developed by Leadiant Biosciences, for the treatment of ADA-SCID in paediatric and adult patients
5 October 2018 - Leadiant Biosciences today announced that the FDA has granted approval to Revcovi (elapegademase-lvlr) injection in the ...
Posted by Michael Wonder on 05 Oct 2018
Akcea and Ionis receive FDA approval of Tegsedi (inotersen) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
5 October 2018 - Tegsedi provides powerful knockdown of TTR protein, delivering significant and sustained benefits in neuropathy and quality of ...
Posted by Michael Wonder on 05 Oct 2018
FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old
5 October 2018 - The U.S. FDA today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) ...
Posted by Michael Wonder on 04 Oct 2018
FDA approves new prophylactic treatment for haemophilia A without factor VIII inhibitors
4 October 2018 - First medicine to significantly reduce treated bleeds compared to prior factor VIII prophylaxis based on an intra-patient ...
Posted by Michael Wonder on 03 Oct 2018
FDA approves Seysara (sarecycline) for the treatment of moderate to severe acne
2 October 2018 - To be launched in U.S. by Almirall SA. ...
Posted by Michael Wonder on 03 Oct 2018
Paratek announces FDA approval of Nuzyra (omadacycline)
2 October 2018 - First and only once-daily IV and oral antibiotic approved to treat both CABP and ABSSSI patients in ...
Posted by Michael Wonder on 02 Oct 2018
FDA approves Kyprolis (carfilzomib) once weekly 70 mg/m2 in combination with dexamethasone for patients with relapsed or refractory multiple myeloma
1 October 2018 - Application reviewed and approved under FDA's real-time oncology review and assessment aid pilot programs. ...
Posted by Michael Wonder on 01 Oct 2018
Antares receives FDA approval of Xyosted (testosterone enanthate) injection for testosterone replacement therapy in adult males
1 October 2018 - A novel subcutaneous auto-injector product approved for once weekly at-home therapy. ...
Posted by Michael Wonder on 01 Oct 2018
Adamis Pharmaceuticals receives FDA approval for its lower dose Symjepi product
27 September 2018 - Adamis Pharmaceuticals Corporation today announced that the U.S. FDA has approved Adamis’ lower dose version (0.15 ...