Vabysmo is the only injectable eye medicine approved simultaneously in the US for wet AMD and DME, with flexible dosing regimens based on patient need
The audit is a PAI for two of its product applications filed from this facility
It would be the first protein-based alternative available in Israel
Evrysdi is approved in 70 countries and submitted in a further 31 with more than 4,500 patients treated to date
Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant
Studies show significant reduction in pain and improved quality of life for patients treated with spinal cord stimulation compared to medication management alone
APS03118 is a novel innovative drug developed by APS with global independent intellectual property rights for unlimited cancer types
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
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
Previously, the use of the drug was limited to patients requiring hospitalization
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