FDA warns Azusa, CA-based Woodward Laboratories about CGMP violations in its production of finished drugs.
United Therapeutics asks FDA not to approve a Liquidia NDA for Yutrepia because the sole supplier of active pharmaceutical ingredients to Liquidia is ...
A California federal court tosses a shareholder class action suit claiming that AcelRx deliberately used marketing materials for its Dsuvia opioid pai...
FDA approves Baxters expanded indication for parenteral (intravenous) nutritient Clinolipid (lipid injectable emulsion) for use in pediatric patients,...
Philips Respironics recalls (Class 1) its Trilogy Evo continuous ventilator devices due to a software issue that may cause a power malfunction.
Novo Nordisk says it will seek FDA approval by the end of the year for Mim8, its next-generation Factor 8a mimetic bispecific antibody for once-weekly...
FDA grants Merus a breakthrough therapy designation for petosemtamab for treating certain patients with recurrent or metastatic head and neck squamous...
FDA issues a warning for healthcare providers and consumers not to use Cue Healths Covid-19 tests due to the increased risk of false results.
