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RSS FeedPosted by Michael Wonder on 25 Oct 2018
FDA grants priority review for ruxolitinib (Jakafi) as a treatment for patients with acute graft-versus-host disease
25 October 2018 - Incyte today announced that the U.S. FDA has accepted for priority review its supplemental new drug ...
Posted by Michael Wonder on 25 Oct 2018
FDA permits marketing of a diagnostic test to aid in the determination of menopausal status
24 October 2018 - Today, the U.S. FDA permitted marketing of the PicoAMH Elisa diagnostic test as an aid in the ...
Posted by Michael Wonder on 25 Oct 2018
Duchesnay announces submission of supplemental new drug application for Osphena (ospemifene) to U.S. FDA seeking approval for the treatment of vaginal dryness, a symptom of vulvar and vaginal atrophy due to menopause
23 October 2018 - Duchesnay announced today that it has submitted a supplemental new drug application to the U.S. FDA ...
Posted by Michael Wonder on 24 Oct 2018
FDA approves new drug to treat influenza
24 October 2018 - Today, the U.S. FDA approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in ...
Posted by Michael Wonder on 24 Oct 2018
Seqirus receives FDA approval of Afluria Quadrivalent (influenza vaccine) for people six months of age and older in the U.S.
17 October 2018 - Seqirus today announced the U.S. FDA has approved Afluria Quadrivalent (influenza vaccine) for use in people ...
Posted by Michael Wonder on 23 Oct 2018
Compass Pathways receives FDA breakthrough therapy designation for psilocybin therapy for treatment-resistant depression
23 October 2018 - Compass Pathways has received breakthrough therapy designation from the US FDA for its psilocybin therapy for ...
Posted by Michael Wonder on 23 Oct 2018
MYR Pharma announces grant of breakthrough therapy designation by US FDA for Myrcludex, the first-in-class entry inhibitor for treatment of chronic hepatitis B and D infections
23 October 2018 - MYR Pharma today announced that US FDA has granted the breakthrough therapy designation for its lead compound ...
Posted by Michael Wonder on 23 Oct 2018
DBV Technologies announces submission of biologics license application for Viaskin Peanut to the U.S. FDA
22 October 2018 - DBV Technologies today announced the submission of a biologics license application to the U.S. FDA for Viaskin ...
Posted by Michael Wonder on 22 Oct 2018
Edge in U.S. cancer drug development spurred by regulatory and reimbursement policies
22 October 2018 - It is presumed that anticipated regulatory and reimbursement policies are important considerations in the research and development ...
Posted by Michael Wonder on 22 Oct 2018
Trump and his team fight for health consumers, starting with drug price transparency
22 October 2018 - Drugs like EpiPen have exorbitant prices due to price gouging. The Trump administration is taking steps to ...
Posted by Michael Wonder on 22 Oct 2018
Eiger BioPharmaceuticals receives FDA rare paediatric disease designation for lonafarnib for the treatment of progeria and progeroid laminopathies and plans NDA filing in 2019
22 October 2018 - Designation enables priority review voucher eligibility upon NDA approval. ...
Posted by Michael Wonder on 20 Oct 2018
Bristol-Myers Squibb provides update on the ongoing regulatory review of Opdivo plus low dose Yervoy in first-line lung cancer patients with tumour mutational burden ≥10 mut/Mb
19 October 2018 - New analysis submitted to U.S. FDA constitutes a major amendment to the Company’s supplemental biologics license application. ...
Posted by Michael Wonder on 20 Oct 2018
FDA approves label update for Genentech’s Rituxan (rituximab) in two rare forms of vasculitis
19 October 2018 - Rituxan label updated to include information for follow up treatment in adult patients with granulomatosis with polyangiitis ...
Posted by Michael Wonder on 20 Oct 2018
FDA approves asthma indication for Dupixent (dupilumab)
20 October 2018 - Only biologic approved for both moderate and severe asthma patients with eosinophilic phenotype. ...
Posted by Michael Wonder on 20 Oct 2018
FDA snubs Novartis bid to repurpose inflammation drug for heart attacks
19 October 2018 - The U.S. FDA has rejected Novartis’s bid to repurpose a drug now approved for rare inflammatory diseases ...