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RSS FeedPosted by Michael Wonder on 07 Oct 2019
Pfenex receives U.S. FDA approval for PF708 to treat osteoporosis
7 October 2019 - Comparative human factors study report expected to be submitted to FDA as early as the second half ...
Posted by Michael Wonder on 05 Oct 2019
FDA grants breakthrough therapy designation to cobimetinib for MEK inhibition in histiocytic neoplasms, research led by MSK
2 October 2019 - Memorial Sloan Kettering Cancer Center announced today that the US FDA has granted a breakthrough therapy designation ...
Posted by Michael Wonder on 05 Oct 2019
Fasenra approved in the US for self-administration in a new pre-filled auto-injector, the Fasenra Pen
4 October 2019 - Fasenra is now the only respiratory biologic that offers the choice of administration at home or ...
Posted by Michael Wonder on 05 Oct 2019
Galderma receives FDA approval for Aklief (trifarotene) 0.005% cream, the first new retinoid molecule for the treatment of acne in over 20 years
4 October 2019 - Next-generation treatment is first option studied and proven effective in both facial and truncal acne. ...
Posted by Michael Wonder on 05 Oct 2019
DBV Technologies announces FDA acceptance of BLA filing for Viaskin Peanut for the treatment of peanut allergy
4 October 2019 - If approved, Viaskin Peanut would be the first and only epicutaneous immunotherapy indicated for this potentially life-threatening ...
Posted by Michael Wonder on 04 Oct 2019
Janssen announces U.S. FDA breakthrough therapy designation granted for niraparib for the treatment of metastatic castration-resistant prostate cancer
3 October 2019 - Niraparib, an orally-administered PARP inhibitor, is currently being investigated for the treatment of patients with metastatic castration-resistant ...
Posted by Michael Wonder on 03 Oct 2019
FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic
3 October 2019 - The U.S. FDA today approved Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) in at-risk ...
Posted by Michael Wonder on 03 Oct 2019
Novartis Entresto receives FDA approval for paediatric heart failure, helping to address critical unmet need for treatment options
1 October 2019 - Entresto is now approved for the treatment of paediatric patients aged 1 year and older with symptomatic ...
Posted by Michael Wonder on 03 Oct 2019
Janssen submits supplemental new drug application to U.S. FDA for Spravato (esketamine) CIII nasal spray for the rapid reduction of depressive symptoms in adults with major depressive disorder who have active suicidal ideation with intent
2 October 2019 - If approved, Spravato would be the first treatment for this severely ill population who historically have been ...
Posted by Michael Wonder on 03 Oct 2019
FDA approves labeling supplement for Puma Biotechnology’s Nerlynx (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer
2 October 2019 - Interim data from the Phase II CONTROL Trial showed that the addition of prophylactic treatment with loperamide ...
Posted by Michael Wonder on 02 Oct 2019
Trump set to nominate Stephen Hahn as FDA commissioner, pending vetting process
1 October 2019 - President Trump is set to nominate Dr. Stephen Hahn to lead the Food and Drug Administration, ...
Posted by Michael Wonder on 02 Oct 2019
The real impact of drug price legislation on biopharmaceutical R&D
2 October 2019 - As outcry around drug prices rages, arguments continue to surface that limiting corporate revenues via price controls ...
Posted by Michael Wonder on 02 Oct 2019
U.S. FDA submission of new drug application for NS-065/NCNP-01 (viltolarsen)
2 October 2019 - Nippon Shinyaku announced that it has completed the submission of its rolling new drug application to the ...
Posted by Michael Wonder on 02 Oct 2019
GSK submits filing to FDA for Trelegy Ellipta use in patients with asthma
2 October 2019 - GSK and Innoviva today announced the filing of a supplemental new drug application to the US ...
Posted by Michael Wonder on 02 Oct 2019
FDA accepts two applications for Merck’s Dificid (fidaxomicin) to treat children aged six months up to 18 years with Clostridium difficile infections
2 October 2019 - Dificid paediatric filings receive priority review classification. ...