Pfizer said it will wait until after the US election to file its COVID-19 vaccine with the US regulator, as it awaits important safety data to become available.
Scynexis has filed for FDA approval of its novel drug ibrexafungerp which – if approved – would be the first broad-spectrum antifungal to reach the US market for vaginal yeast infections in
Harmony Biosciences has scored an expanded use for its Wakix narcolepsy drug to include cataplexy – a symptom of the sleep disorder that can cause total body collapse.
Eli Lilly has put a clinical trial of its COVID-19 antibody therapy on hold after FDA inspectors found serious quality control problems at the plant, according to press reports.
The FDA may have been blocked from issuing stricter guidelines for emergency approval of COVID-19 vaccines by the Trump administration, but it has still managed to make its new approach pub
The EU regulator is poised to start a review of AstraZeneca and Oxford University’s COVID-19 vaccine, but the FDA is widening its investigation into the shot’s safety, according to reports