Cialis Back Pain May Be Due To Greater PDE11 Affinity Than Viagra, Levitra

Cialis’ greater affinity for PDE11 than other PDE5 inhibitors is the likely explanation for the greater incidence of back pain and myalgia seen with the Lilly/Icos erectile dysfunction agent, FDA speculates in review documents.

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Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
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While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Chikungunya At US CDC: Bavarian Nordic’s Vimkunya Recommended, Valneva’s Ixchiq Adjusted

 

Bavarian Nordic's Vimkunya added the US CDC immunization committee's recommendation to its FDA approval, while Valneva's Ixchiq faces a precaution for use in people aged 65 and older.

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.