News

After delay, FDA approves Novavax’s Covid-19 vaccine, but only for older people and those at high risk
After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter ...
FDA approves Novavax COVID vaccine with new conditions
The U.S. Food and Drug Administration on Friday approved Novavax's COVID-19 vaccine, but placed additional conditions on ...
FDA approves Novavax COVID-19 shot but with unusual restrictions
The Food and Drug Administration has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual ...
The Pharma Letter2d
FDA Approves AbbVie’s Emrelis
Emrelis (telisotuzumab vedotin-tllv) has been granted accelerated approval by the US Food and Drug Administration (FDA), said ...
Nyxoah outlines U.S. Genio launch plan with 50-member team as FDA approval expected Q2 2025
Q1 2025 Management View CEO Olivier Taelman emphasized the pivotal progress toward full PMA approval in the United States, ...
FDA says ‘dangerous’ substance known as ‘gas station heroin’ poses major risk to young people
FDA Commissioner Martin Makary sounded the alarm on tianeptine, also known as "gas station heroin," and its growing adverse ...
FDA issues warning about ‘gas station heroin’
According to the FDA, tianeptine has a high potential for abuse with serious harmful effects by itself or with other drugs, ...
WVXU4d
FDA orders pharmacies to cease production of compounded weight-loss drugs
Ohio Attorney General Dave Yost sent letters to 14 medical spas warning them to stop making false or misleading claims about ...
BioWorld1d
Incyte adds more FDA approvals for Zynyz in cancer
Incyte Corp.’s Zynyz (retifanlimab-dlwr) has received another U.S. FDA approval and put some distance between it and a 2021 ...
The Pharma Letter2d
Incyte granted FDA approval of Zynyz for SCAC
The US Food and Drug Administration (FDA) has approved Incyte’s (Nasdaq: INCY) Zynyz (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination ...