Rune Labs on Monday said the San Francisco-based startup has received clearance from the U.S. Food and Drug Administration to use the Apple Watch to monitor tremors and other common symptoms in patients with Parkinson’s disease.
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.
A federal agency will start a review if the U.S. Food and Drug Administration properly conducted the health regulator’s inspection of Abbott’s Michigan plant and oversaw baby formula recalls that led to severe shortages in the United States.
Pfizer Inc. and partner BioNTech completed the filing with the U.S. drugs regulator seeking authorization for their COVID-19 vaccine in children under 5 years of age.
The U.S. Food and Drug Administration said on Wednesday it has withdrawn the health regulator’s approval for TG Therapeutics Inc.’s lymphatic cancer treatment Ukoniq over concerns of higher risk of death in patients receiving the drug.
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).
Danone SA has been doubling shipments to the United States of Neocate formula for infants allergic to cow’s milk while Enfamil maker Reckitt is also working to boost supplies amid a nationwide shortage, company executives said on Wednesday.
White House COVID-19 response coordinator Dr. Ashish Jha said on May 22 he expects a U.S. Food and Drug Administration decision on authorizing Moderna’s vaccine for children under age five within the next few weeks.
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.