U.S. NIAID-sponsored trial will evaluate heterologous booster regimens, including NVX-CoV2373, after primary series with current USFDA approved or emergency use authorized-vaccines
The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial
The company plans to launch the product immediately
The drug is indicated for use in combination with other drugs
The USFDA has granted a qualified infectious disease product (QIDP) designation to WCK 6777, which signifies its ability to meet unmet medical needs and facilitates a faster approval process
Nebivolol is used alone or together with other medicines to treat high blood pressure
This drug-device combination product is a metered-dose inhaler (MDI), which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing)
The facility registration, along with DMF registration and GMP certification provides peace of mind to clients looking to use our iPSCs for clinical and commercial use in the United States, Japan, and other global markets
Amit Jaju, Senior Managing Director, India in an interview with Thomas C Thottathil outlined the steps Indian pharma companies should follow to be compliant with global regulatory requirements
It signals Cordis' renewed investment in innovation
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