The FDA has approved a label expansion for the interleukin-23 inhibitor guselkumab to include the inhibition of structural ...
Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to include evidence in the TREMFYA® ...
5don MSNOpinion
Treatment for millions of Americans at stake in ‘skinny label’ Supreme Court case
The Supreme Court will soon decide a case that could upend the balance built into a bipartisan law that has accelerated the ...
Morning Overview on MSN
The FDA just approved Auvelity for Alzheimer-related agitation — the first non-antipsychotic ever cleared for the hardest behavioral symptom families have to man…
Families caring for someone with Alzheimer’s disease now have a second FDA-cleared drug for agitation, and for the first time ...
Natco Pharma and Lupin gained FDA approval for bioequivalent generic eribulin mesylate injection, potentially reducing ...
The Food and Drug Administration (FDA) on May 22, 2026, approved Datroway (datopotamab deruxtecan-dlnk) for adult patients ...
A new guidance document published by the US Food and Drug Administration (FDA) is intended to clarify how drugs approved through the accelerated approval pathway should be labeled. FDA's accelerated ...
The FDA has approved an updated label for beremagene geperpavec-svdt (B-VEC), a topical gene therapy for dystrophic epidermolysis bullosa (DEB), which expands the indication from ages 6 months and ...
The US Food and Drug Administration (FDA) on Tuesday finalized guidance on labeling drugs and biologics approved under the accelerated approval pathway. FDA's accelerated approval program allows the ...
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