Gilead’s total revenue for Q2 increased 1% to $6.3 billion compared to Q2 in 2021. Overall, the company exceeded both its own expectations and the predictions of market analysts for the second quarter.
Pfizer said it submitted a New Drug Application for Paxlovid to the FDA for the treatment of COVID-19 in vaccinated and unvaccinated people at high risk for progression to severe illness.
For years, PTC Therapeutics has attempted to win regulatory approval for its Duchenne Muscular Dystrophy drug, Translarna (ataluren), but time and time again, the U.S. Food and Drug Administration has rejected the attempts. Now, the company believes it has data that will support another filing for possible approval.
The U.S. Food and Drug Administration has a handful of PDUFA dates over the next two weeks.
Mallinckrodt plc today announced the company has resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration for the investigational agent terlipressin to treat adults with hepatorenal syndrome (HRS) involving rapid reduction in kidney function.
Bristol Myers Squibb (BMS) announced late-breaking data Wednesday showing that deucravacitinib, an allosteric tyrosine kinase 2 inhibitor, met the primary endpoint in the treatment of systemic lupus erythematosus.
Verrica Pharmaceuticals has received the company’s third Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its New Drug Application for the molluscum contagiosum treatment candidate VP-102.
AbbVie submitted a New Drug Application to the U.S. Food and Drug Administration for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.