Drug Approval | July 08, 2022
Dr. Reddy's Laboratories updates on PAI of formulations facility
The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.
The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.
The vaccine is under FDA review
Sanofi will begin to ship their vaccines helping to ensure more people will be immunized
Companies finalize termination with an agreed-upon settlement fee of $55M to be paid to Akebia
Analysis of Post-Marketing Safety Data Shows Consistent Findings with Safety Profile Reported in Clinical Trials of Edaravone
105 million 30 µg, 10 µg and 3 µg doses to be delivered into Q4 2022, with an option for the U.S. Government to purchase up to 195 million additional doses
The over-the-counter market has long been an important segment of Glenmark’s portfolio around the world
The FDA informed Astellas that it did not have sufficient information to assess the risks to subjects
By applying digital technologies, pharma companies can significantly improve their operational and decision-making capabilities
Both vaccine candidates demonstrated a favorable safety and tolerability profile similar to the Pfizer-BioNTech COVID-19 Vaccine
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