Vistagen announced topline results from a repeat dose study of fasedienol for acute treatment of social anxiety disorder, showing favorable safety and tolerability profiles along with efficacy signals across primary and secondary endpoints in both repeat and single dose administrations.
India's drug regulator has taken enforcement action against approximately 90% of inspected pharmaceutical facilities identified as high-risk under a nationwide quality initiative, as authorities intensify oversight amid increased global scrutiny of Indian-made drugs.
Lawsuits over vision loss risks from Saxenda (liraglutide) emerge as Medicare begins covering GLP-1 medications for seniors over 65, raising questions about proper usage and safety in older populations.
The New England Journal of Medicine retracted the main clinical trial used to approve Amgen's $500 million drug Tavneos, following allegations of data manipulation. The European Medicines Agency had previously recommended revoking the drug's approval over data integrity concerns.
ADC Therapeutics shares plunged 53% in premarket trading after a late-stage study of its blood cancer drug showed more deaths among treated patients, despite meeting its main goal. The safety signal represents a significant setback for the company's development program.
Swiss drugmaker Roche presented latest clinical trial data for its experimental multiple sclerosis drug at a major conference, setting the stage for regulatory approval submissions, though safety questions remain under scrutiny.
