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RSS FeedPosted 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 ...
Posted by Michael Wonder on 14 Mar 2018
FDA chief becomes point man on drug prices
14 March 2018 - Scott Gottlieb, head of the FDA, has emerged as a key figure in the Trump administration’s ...
Posted by Michael Wonder on 14 Mar 2018
NovaBiotics’ Lynovex receives fast track designation for cystic fibrosis exacerbations
12 March 2018 - NovaBiotics announces receipt of fast track designation for its cystic fibrosis therapy, Lynovex, from the United States ...
Posted by Michael Wonder on 14 Mar 2018
FDA grants priority review to Merck’s supplemental biologics license application for Keytuda (pembrolizumab) for treatment of advanced cervical cancer
13 March 2018 - First filing acceptance for an anti-PD-1 therapy in cervical cancer. ...
Posted by Michael Wonder on 13 Mar 2018
Lumasiran granted breakthrough therapy designation by the United States FDA
12 March 2018 - Alnylam Pharmaceuticals announced today that Sanofi Genzyme has declined its opt-in for the development and commercialisation ...
Posted by Michael Wonder on 13 Mar 2018
Proteostasis Therapeutics announces FDA grants breakthrough therapy designation for PTI-428 in cystic fibrosis
12 March 2018 - Designation granted for PTI-428 for the treatment of CF patients based on the results from a recent ...
Posted by Michael Wonder on 13 Mar 2018
AmnioFix injectable granted regenerative medicine advanced therapy designation by the FDA for the treatment of osteoarthritis of the knee
9 March 2018 - MiMedx Group today announced that the U.S. FDA has granted MiMedx's micronized amniotic tissue, AmnioFix Injectable, ...
Posted by Michael Wonder on 12 Mar 2018
Hikma provides an update on the status of its ANDA for generic Advair Diskus
12 March 2018 - Hikma Pharmaceuticals announces that it is has received a response from the United States FDA in ...