Complete Response Letter

An envelope with rejected mark Vector illustration
Manufacturing

Manufacturing issues prompt FDA rejection of Hyloris antiviral

The FDA has rejected Hyloris' antiviral valacyclovir, an oral suspension for infections caused by herpes simplex, because of manufacturing issues.
Kevin Dunleavy Mar 13, 2026 8:40am
Zynyz

Novo's Indiana plant claims another victim in Incyte's PD-1

Mar 9, 2026 10:45am
Alert

FDA rejection letters flag data concerns for AZ, GSK biologics

Mar 3, 2026 11:30am
big wave over ship in storm
Favicon Fierce Biotech

Disc lays off 20% of workforce in wake of FDA rejection

Mar 3, 2026 10:45am
Saphnelo

FDA rejects AZ's subcutaneous version of lupus drug Saphnelo

Feb 3, 2026 9:55am
two red lights

FDA rejects new drug from Aquestive, expansion for Pharming

Feb 2, 2026 11:30am