The inspection report contains no 'critical' observations and only one of the deficiencies is categorized as 'major' which is being addressed expeditiously in consultation with the regulatory agency
Bortezomib for injection is used to treat certain types of cancer such as multiple myeloma and mantle cell lymphoma
The companies expect to complete the submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression is anticipated in the first half of 2023
The announcement follows FDA 510(k) clearance of device
The inspection was triggered by Shilpa's submission of applications for four ANDA's to seek approval to use this site as an alternate testing laboratory
Blood test for early detection of Alzheimer's Disease (AD) risk will lead to better patient care, physicians say; US. adults call for earlier evaluation and more education
State Ministers of Health and Medical Education to Participate in the meeting from 5th to 7th May
Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks
Submission to regulators globally is based on phase 2/3 studies of mRNA-1273 in young children
Cysoni is a bionic device that paces the heart with real-time respiratory modulation
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