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.
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 ...
The Norman Transcript2h
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 ...
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 ...
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.
Healio2h
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 ...
Shanghai Junshi’s JS212 Drug Application Accepted, Boosting Cancer Therapy Pipeline
Discover outperforming stocks and invest smarter with Top Smart Score StocksFilter, analyze, and streamline your ...
Vanda asserts FDA review of tradipitant was flawed
Vanda (VNDA) has written a letter to FDA Commissioner Robert Califf asserting that the review of the market application for ...
Healio2d
FDA grants priority review to oral non-small cell lung cancer drug
The FDA granted priority review to a new drug application for sunvozertinib as an oral treatment for certain patients with ...
JD Supra1h
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 ...
Drug Company to Share Revenues With Indigenous People Who Donated Their Genes
Variant Bio, a small biotech company based in Seattle, is using genetic information from Indigenous people to develop drugs ...