Drug Approval | December 04, 2025
Zydus receives EIR for the injectable facility located at Jarod
This inspection was conducted following the warning letter issued by the USFDA
This inspection was conducted following the warning letter issued by the USFDA
The PCR-based test, delivered via Roche’s cobas liat system, allows results to be obtained during a patient consultation in GP practices and Emergency Rooms
The company is excluding data from the affected sites to maintain the study's integrity
FDA's withholding of the PRV was contrary to law because no drug product containing phenobarbital sodium was 'previously approved'
LYMPHIR addresses a clear clinical need in a disease with limited treatment options
The company also revealed that MK-2214 has received Fast Track Designation from the U.S. Food and Drug Administration
Patients can now get the starting 2.5 mg dose for $299 per month
This relates to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States
The fresh capital will propel Cordance into its first-in-human clinical trial
The deliveries bring the innovative medicine to communities heavily impacted by HIV just five months after U.S. FDA approval
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