The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.
Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.
Alopecia areata usually presents as a few small bald patches in the head
Risk management plans can serve as a safeguard, helping manufacturers prepare for and respond to hazards that could lead to drug supply disruptions and shortages
In clinical trials, treatment proved more effective than other therapies evaluated
This action makes Veklury the first approved Covid-19 treatment for children less than 12 years of age
This drug-device combination product is a metered-dose inhaler (MDI), which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing)
The NMPA Breakthrough Therapy Designation was based on results from the Phase 2 TRUST trial of ROS1 fusion-positive NSCLC patients treated with taletrectinib, a new generation of potent ROS1 inhibitors
Restasis has been approved for use in the U.S. for nearly 20 years, but until today, there was no approved generic product of this drug
Previously, the use of the drug was limited to patients requiring hospitalization
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