Drug Approval | December 21, 2021
U.S. FDA approves ANI’s rifabutin capsules, launch soon
The capsules are the generic version of the reference listed drug Mycobutin
The capsules are the generic version of the reference listed drug Mycobutin
First Emergency Use Listing granted by WHO for a protein-based Covid-19 vaccine
2022 is going to be the year of opportunities and innovations from the medical industry in India
The company will collaborate with U.S.-based colleagues to help life sciences companies improve commercial effectiveness
Authorized booster increases Omicron neutralizing antibody levels approximately 37-fold
The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research
The company is now ready to offer clinical testing anywhere in the world after early case studies conducted in Israel have demonstrated recovery within 48 hours
EMA’s CHMP advice states that Paxlovid can be used for treatment of adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease
The deepCDR engine combines deep sequencing and deep learning methods with a proprietary mammalian display process to select from a wide range of antibodies and rapidly identify candidates with the highest possible affinity and developability profiles
It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity
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