Drug to treat rare pediatric disease accepted for FDA review
A subsidiary of a Miami-based company is inching closer to FDA approval for a drug that treats a rare pediatric disease.
JD Supra28m
Transparency Is the Best Medicine: Device Parts Don’t Justify Orange Book Listing
The US Court of Appeals for the Federal Circuit affirmed a district court’s delisting of patents from the Orange Book because the patent claims ...
The Norman Transcript1h
New drug development tool could revolutionize industry
A University of Oklahoma professor and his team have discovered a new way to put atoms into drug molecules that could ...
Targeted Oncology2d
FDA Clears Investigational New Drug Application for REC-4539 in SCLC
The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small ...
JD Supra2d
Balancing Safety and Accessibility: FDA Broadens Approval Pathway for Nonprescription Drugs by Finalizing the ‘ACNU’ Rule
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...
IPWatchdog1h
Novartis’ Entresto Patent Claims Revived by CAFC
The U.S. Court of Appeals for the Federal Circuit (CAFC) today issued a precedential decision reversing a district court’s ...
Solid Biosciences Gains FDA Clearance for New Drug Application
Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.
Cure Today6d
FDA Accepts New Drug Application For Taletrectinib in ROS1+ NSCLC
The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell ...
Zacks.com on MSN10d
Corcept Submits Application for Another Cushing's Syndrome Drug
Corcept Therapeutics Incorporated CORT recently announced the submission of a new drug application (NDA) to the FDA for its ...
Healio1h
Brimochol PF achieves endpoints in second phase 3 presbyopia trial
Patients with presbyopia experienced improvements in near vision after treatment with Brimochol PF in a second phase 3 ...
Business Wire10d
Verastem Oncology Announces FDA Acceptance and Priority Review of New Drug Application for Avutometinib in Combination with Defactinib for the Treatment of R…
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, ...
Shanghai Junshi’s JS212 Drug Application Accepted, Boosting Cancer Therapy Pipeline
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