FDA-approved AVLAYAH, BBB TransportVehicle platform, $1.17B liquidity & runway—assess valuation, pipeline upside now.
The FDA rejected the promising skin cancer drug RP1 twice, leaving many puzzled and worried about what this means for other ...
Biosimilar formulation development requires navigating around scientific, regulatory, and legal challenges, according to Sung ...
Learn how host cell protein (HCP) testing methods are used to detect impurities and ensure quality in biologics manufacturing.
2d
FDA approval, fundraising, and the reality of building in healthcare according to BioticsAI founder
BioticsAI CEO Robhy Bustami joined Isabelle Johannessen on Build Mode to discuss how the company has navigated a highly ...
Regulatory approval is a major milestone in the drug development process, but it is not the final chapter in the journey.
After the approval and rescinding of one company's designation, experts examine why sponsors might still leverage the program and what might give them pause.
An FDA initiative to implement real-world clinical trials could dramatically accelerate the pace at which new treatments ...
Emergent BioSolutions Inc. (NYSE: EBS) today announced a multi-year agreement with SAB Biotherapeutics, Inc. (Nasdaq: SABS, SAB BIO) to support the process development and manufacturing of SAB-142, ...
Discover how quality-driven drug development and AI accelerate safer medicines, reduce risk, and improve patient outcomes.
The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
The U.S. Food and Drug Administration today announced two major steps as part of an initiative to advance the implementation of real-time clinical trials (RTCT). First, the agency unveiled the ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results