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RSS FeedPosted by Michael Wonder on 20 Mar 2018
FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy
20 March 2018 - The U.S. FDA today approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage ...
Posted by Michael Wonder on 20 Mar 2018
Amplyx Pharmaceuticals receives fourth “Qualified Infectious Disease Product” designation from the FDA for APX001
12 March 2018 - Designation granted for treatment of cryptococcosis provides priority review, fast-track status and five additional years of ...
Posted by Michael Wonder on 20 Mar 2018
U.S. FDA grants priority review for a supplemental new drug application for Xtandi (enzalutamide) in non-metastatic castration-resistant prostate cancer
19 March 2018 - Application seeks to expand the indication of Xtandi to include men with non-metastatic castration-resistant prostate cancer. ...
Posted by Michael Wonder on 19 Mar 2018
FDA’s new pilot program aims for more transparency about new drug approvals
19 March 2018 - When FDA approves a new drug, it has been found safe and effective when used under the ...
Posted by Michael Wonder on 19 Mar 2018
pSivida announces FDA acceptance for filing of new drug application for Durasert three-year treatment for posterior segment uveitis
19 March 2018 - pSivida today announced that its new drug application for Durasert three-year treatment for posterior segment uveitis ...
Posted by Michael Wonder on 19 Mar 2018
FDA grants fast track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease
19 March 2018 - The designation is based on the investigational new drug application for SSc-ILD and the anticipated efficacy and ...
Posted by Michael Wonder on 18 Mar 2018
Former FDA commissioners say right-to-try bills could endanger ‘vulnerable patients’
18 March 2018 - Four former commissioners of the FDA are expressing opposition to congressional “right to try” legislation, just ...
Posted by Michael Wonder on 18 Mar 2018
FDA approves Hizentra (immune globulin subcutaneous [human] 20% liquid) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy
16 March 2018 - First and only subcutaneous immunoglobulin approved for the treatment of CIDP based on the largest controlled clinical ...
Posted by Michael Wonder on 16 Mar 2018
Abeona Therapeutics receives FDA rare paediatric disease designation for ABO-202 gene therapy program in CLN1 disease
15 March 2018 - Company’s fourth gene therapy program to receive rare paediatric disease designation, enabling priority review voucher. ...
Posted by Michael Wonder on 16 Mar 2018
Exelixis submits U.S. supplemental new drug application for Cabometyx (cabozantinib) for previously treated advanced hepatocellular carcinoma
15 March 2018 - In the pivotal phase 3 CELESTIAL trial, Cabometyx provided a statistically significant and clinically meaningful improvement ...
Posted by Michael Wonder on 15 Mar 2018
Destiny Pharma announces FDA fast track designation for lead clinical candidate, exeporfinium chloride
15 March 2018 - Destiny Pharma today announces that its lead clinical candidate exeporfinium chloride (XF-73) has been granted Fast ...
Posted by Michael Wonder on 15 Mar 2018
Ovid Therapeutics announces OV101 granted fast track designation by U.S. FDA for treatment of Fragile X syndrome
15 March 2018 - Second fast track designation for OV101 within three months. ...
Posted by Michael Wonder on 15 Mar 2018
Janssen announces U.S. FDA breakthrough therapy designation for erdafitinib in the treatment of metastatic urothelial cancer
15 March 2018 - Erdafitinib, an oral pan-fibroblast growth factor receptor tyrosine kinase inhibitor, shows promise as the first targeted agent ...
Posted by Michael Wonder on 15 Mar 2018
FDA accepts for filing supplemental biologics license application for Xeomin (incobotulinumtoxinA) in adult patients with sialorrhoea
14 March 2018 - Merz North America announced today that the U.S. FDA has accepted for filing a supplemental biologics license ...
Posted by Michael Wonder on 14 Mar 2018
House defeats ‘right-to-try’ legislation to allow expanded use of experimental drugs
13 March 2018 - In a major setback for Republicans, the House rejected “right-to-try” legislation Tuesday evening that would have ...