On July 11th Dr. Mathew Winton went to Capitol Hill with senators and staff from both parties to discuss collaboration with the FDA regarding the pending termination of the Priority…
On December 13, 1996, Health Canada issued a policy statement called Priority Review of Drug Submissions which: provided for the "fast-tracking" of eligible New Drug Submissions (NDS) and Supplemental New…
Dupixent (dupilumab) is currently the first and only FDA-approved treatment for eosinophilic esophagitis (EoE) in people ages 12 or older who weigh at least 40 kg (88.18 pounds). The…
If gastric cancer is localized (has not yet spread), it carries a significantly higher 5-year survival rate of 72-75%. But once the cancer spreads, the rate falls lower: 35%…
According to a recent article from WFMZ+, the FDA has recently approved Regeneron's supplemental Biologics License Application (sBLA) for Dupixent, granting it priority review. Dupixent, also known by the generic…
According to Pharmacy Times, the FDA recently granted Priority Review status to luspatercept-aamt (Reblozyl). The therapy, for which its developer has submitted a supplemental biologics license application (sBLA), is designed…
In early June 2021, Epidermolysis Bullosa News reported that Filsuvez (Oleogel-S10), a topical gel for epidermolysis bullosa (EB), received Priority Review designation from the FDA. Filsuvez Developed by Amryt Pharma,…
Recently, the FDA granted Priority Review status to a supplemental New Drug Application (sNDA) for zanubrutinib, MPR reports. While the treatment, under the brand name Brukinsa, is currently indicated for…
In a news release from April 2021, biopharmaceutical company Jazz Pharmaceuticals, Inc. ("Jazz") shared that the FDA accepted its supplemental New Drug Application (sNDA) for review in relation to Xywav,…
According to a press release from the biopharmaceutical company Sanofi, the company's investigational treatment avalglucosidase alfa will have its Biologics License Application (BLA) evaluated by the US Food and Drug…
According to a press release from the biopharmaceutical company Sanofi, the Biologics License Application (BLA) for its drug avalglucosidase alfa has been accepted by the US Food and Drug Administration…
Earlier this week, the FDA granted Priority Review status to use a combination of Opdivo-Cabometyx as a treatment for patients with renal cell carcinoma (RCC). According to Healio, Opdivo (nivolumab)…
According to a drug filing and press release from Pharmaceutical Business Review, the FDA granted a priority review to GlaxoSmithKline for their humanized monoclonal antibody therapy, Nucala (mepolizumab). Currently,…
As reported in Cystic Fibrosis News Today, a new drug combination created for Cystic Fibrosis, a mix of Vertex's elexacaftor, tezacaftor, and Kalydeco has been granted priority review. The new…
© Copyright 2024 Patient Worthy
Sign Up With a Patient Worthy Account and Share Your Rare Story
- OR -
Make a difference, share your experiences and get paid. Opt-in and join Patient Worthy's panel for paid opportunities such as surveys, market research, patient advisory panels and more.
- OR -
Make a difference, share your experiences and get paid. Opt-in and join Patient Worthy's panel for paid opportunities such as surveys, market research, patient advisory panels and more.
