FDA extends review of Fortress Biotech's CUTX-101 drug
Fortress Biotech, Inc. (NASDAQ:FBIO), a biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has extended the target action date for the New Drug Application ...
FDA Unveils Grounds For Rejecting Vanda Pharmaceuticals Stomach Paralysis Candidate
FDA denies Vanda's Tradipitant application for gastroparesis, urging new trials for efficacy and safety. Vanda disputes the ...
manilatimes5d
Chimerix to Speak Today at The White House Cancer Moonshot Forum
Chimerix (NASDAQ: CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, announced today that Dr ...
SpringWorks: PDUFA Review Date Could Lead To Next Approved Pipeline Candidate
SpringWorks has shown strong revenue growth with OGSIVEO, achieving a 23% increase from Q2 of 2024 to Q3 of 2024. See why I ...
Vanda Pharmaceuticals Inc.: Vanda's Letter to FDA Commissioner Highlights Faulty Gastroparesis NDA Review
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) letter to FDA Commissioner highlights faulty gastroparesis NDA review. As ...
The National Law Review10d
Transparency Is the Best Medicine: Device Parts Don’t Justify Orange Book Listing
You are responsible for reading, understanding, and agreeing to the National Law Review's (NLR’s) and the National Law Forum ...
Pharmaceutical Technology11d
FDA accepts Sentynl’s Menkes disease therapy NDA for priority review
The FDA has accepted for filing and priority review Sentynl Therapeutics’ CUTX-101 NDA for the treatment of Menkes disease.
Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease
Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025Cyprium is eligible to receive royalties and up to $129 ...
The Indian Express15d
Yogi minister: ‘Dispute is with a few conspirators in UP govt … STF should be renamed shadyantrakari force’
When the principal secretary was involved in the process and the CMO too knew ... Is the conspirator from the NDA or the Opposition? Because the MLA you are referring to is from the SP. Did that MLA ...
Pharmaceutical Technology16d
China’s NMPA prioritises HUTCHMED’s lung cancer therapy review
China NMPA has granted acceptance and priority review for the NDA for HUTCHMED’s ORPATHYS (savolitinib) and TAGRISSO (osimertinib) combination ...