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RSS FeedPosted by Michael Wonder on 29 May 2019
Health advocate says FDA must walk a 'fine line' to ensure affordable drugs are safe
29 May 2019 - Public health advocate Dinesh Thakur said in an interview that aired Wednesday that the FDA is ...
Posted by Michael Wonder on 29 May 2019
U.S. FDA grants priority review for Vascepa (icosapent ethyl) supplemental new drug application seeking cardiovascular risk reduction indication
29 May 2019 - PDUFA date assigned is 28 September 2019, four months sooner than expected. ...
Posted by Michael Wonder on 29 May 2019
FDA approves Revlimid (lenalidomide) in combination with rituximab for the treatment of adult patients with previously treated follicular lymphoma or marginal zone lymphoma
28 May 2019 - Approval marks the first chemotherapy-free combination regimen for patients who have relapsed or did not respond to ...
Posted by Michael Wonder on 29 May 2019
Sermonix receives FDA fast track designation for investigational drug lasofoxifene
28 May 2019 - Designation allows for expedited development and review of lasofoxifene as a potential precision medicine treatment for women ...
Posted by Michael Wonder on 28 May 2019
Assessment of the clinical benefit of cancer drugs receiving accelerated approval
28 May 2019 - When a cancer drug that has received accelerated approval from the US FDA is claimed to have ...
Posted by Michael Wonder on 28 May 2019
Allergan and Gedeon Richter receive U.S. FDA approval for expanded use of Vraylar (cariprazine) in the treatment of bipolar depression
28 May 2019 - New indication makes Vraylar first and only dopamine and serotonin partial agonist to treat the full spectrum ...
Posted by Michael Wonder on 25 May 2019
RegenxBio announces first FDA approval of a gene therapy based on its proprietary NAV technology platform
24 May 2019 - FDA approval of Novartis' Zolgensma for the treatment of paediatric patients with SMA marks the first regulatory ...
Posted by Michael Wonder on 24 May 2019
FDA approves Jakafi (ruxolitinib) for the treatment of patients with acute graft-versus-host disease
24 May 2019 - Jakafi is the first and only FDA approved treatment for patientswith steroid-refractory acute graft-versus-host disease. ...
Posted by Michael Wonder on 24 May 2019
FDA approves first PI3K inhibitor for breast cancer
24 May 2019 - Today, the U.S. FDA approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved ...
Posted by Michael Wonder on 24 May 2019
AveXis announces innovative Zolgensma gene therapy access programs for US payers and families
24 May 2019 - Annualised cost of Zolgensma is USD 425,000 per year for 5 years; 50% less than multiple established ...
Posted by Michael Wonder on 24 May 2019
FDA approves innovative gene therapy to treat paediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality
24 May 2019 - The U.S. FDA today approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less ...
Posted by Michael Wonder on 23 May 2019
FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections
23 May 2019 - Today, the U.S. FDA permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for ...
Posted by Michael Wonder on 23 May 2019
Novartis CEO plans gene therapy price 'far lower' than $4 million to $5 million range
23 May 2019 - Novartis AG’s top executive said on Wednesday it expects to price its gene therapy for spinal ...
Posted by Michael Wonder on 23 May 2019
Iovance Biotherapeutics announces breakthrough therapy designation for LN-145 for treatment of advanced cervical cancer patients who have progressed on or after chemotherapy
22 May 2019 - Iovance Biotherapeutics today announced that the U.S. FDA has granted breakthrough therapy designation to Iovance TIL therapy ...
Posted by Michael Wonder on 23 May 2019
Avadel Pharmaceuticals announces FDA acceptance of new drug application for AV001
22 May 2019 - AV001 granted priority review. ...