The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US
Previously, the use of the drug was limited to patients requiring hospitalization
UCB plans to submit regulatory applications in Q3 2022
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
It is the first CAR T Therapy approved for the treatment of multiple myeloma in Japan
However, these won’t be available at the nearest chemist store soon
The company will receive an upfront payment as well as regulatory and sales based milestone payments from Lotus
They will commercialize molnupiravir in the international markets
The hospital will be operated under the name and style of Max Super Speciality Hospital, Dwarka
This is the company’s first partnership arrangement in China
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