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RSS FeedPosted 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 08 Oct 2018
Akcea announces its access and distribution strategy for Tegsedi (inotersen)
5 October 2018 - Express Scripts’ Accredo selected as specialty pharmacy for its expertise in providing timely access and support services ...
Posted by Michael Wonder on 06 Oct 2018
U.S. FDA accepts Karyopharm’s new drug application for selinexor and grants priority review
5 October 2018 - Application seeks accelerated approval for selinexor as a treatment for patients with penta-refractory multiple myeloma. ...
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
Evaluating progression-free survival as a surrogate outcome for health-related quality of life in oncology
1 October 2018 - Progression-free survival has become a commonly used outcome to assess the efficacy of new cancer drugs. However, ...
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 04 Oct 2018
VistaGen Therapeutics receives FDA fast track designation for development of AV-101 as a non-opioid treatment for neuropathic pain
3 October 2018 - Second FDA fast track designation for AV-101 since December 2017 marks another milestone for VistaGen's R&D pipeline. ...
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 03 Oct 2018
ADMA Biologics resubmits biologics license application for RI-002
1 October 2018 - ADMA Biologics announces that the Company has responded to the July 2016 complete response letter and ...
Posted by Michael Wonder on 02 Oct 2018
Clovis Oncology receives breakthrough therapy designation for Rubraca (rucaparib) for treatment of BRCA1/2-mutated metastatic castration resistant prostate cancer
2 October 2018 - Breakthrough therapy designation granted to Rubraca based on initial data from on-going TRITON2 Phase 2 study in ...
Posted by Michael Wonder on 02 Oct 2018
Statement from FDA Commissioner on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions
2 October 2018 - When I announced the Drug Competition Action Plan, or DCAP, in June 2017, I committed the ...
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. ...