The FDA is hoping to repurpose GSK’s Wellcovorin for cerebral folate deficiency; Pfizer acquired fast-moving weight-loss ...
While last week’s recommended changes by CDC advisors to the MMRV vaccine schedule are unlikely to have a tangible effect on ...
In its rejection letter, the FDA flagged problems at a third-party fill-finish site owned by Novo Nordisk. Issues at this ...
The agency also pointed to the use of Tylenol and other acetaminophen products during pregnancy as being potentially linked ...
An advisory committee last year found that Zynquista’s benefit-risk profile in type 1 diabetes was unfavorable due to cases ...
By improving gait stability, Ionis’ zilganersen could be “potentially disease modifying,” according to analysts at William ...
Small and large drugmakers alike have made big, proactive moves to secure the production capacity that will be vital to ...
The company was expecting a decision from the FDA by Sept. 28 for its oral drug tolebrutinib, but an update to the drug’s ...
In an interview with German-language outlet Neue Zuercher Zeitung, Novartis CEO Vas Narasimhan said the company is exploring ...
For the last two years, Keytruda has reigned as the world’s top-selling drug—a distinction under threat with key patent ...
MapLight Therapeutics, the second biotech to launch a Nasdaq bid this month, is a neuro-focused company advancing treatments ...
Building and scaling biopharma workforces can go beyond recruiting permanent employees to include fractional workers and ...
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