On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it was embracing “radical transparency” by publishing more than 200 Complete Response Letters (CRLs) — letters the agency issues to a sponsor when...more
8/26/2025
/ Capital Markets ,
Disclosure Requirements ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Popular ,
Publicly-Traded Companies ,
Regulatory Authority ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management ,
Securities and Exchange Commission (SEC) ,
Securities Litigation
Following a recent decision from the U.S. Court of Appeals for the Ninth Circuit in Khoja v. Orexigen Therapeutics, Inc., plaintiffs alleging securities fraud against companies in the pharmaceutical and life sciences sector...more
6/18/2019
/ Adverse Events ,
Defense Strategies ,
Extrinsic Evidence ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Litigation Strategies ,
Motion to Dismiss ,
Pharmaceutical Industry ,
Pre-Trial Motions ,
Prescription Drugs ,
Securities Fraud ,
Securities Litigation ,
Stock Drop Litigation