Provention Bio will have to wait a little bit longer to see if the U.S. Food and Drug Administration will approve its diabetes prevention drug, teplizumab. On Thursday, the company announced the regulatory agency extended its review period by three months for the Biologics License Application (BLA) to Nov. 17.
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.
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.
United Therapeutics announced on Tuesday that the company received U.S. Food and Drug Administration approval for its therapeutic Tyvaso DPI. Tyvaso DPI marks the first approval of a dry powder inhaler for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).