Lia DeGroot

The Supreme Court on Wednes­day heard oral ar­gu­ments in two cas­es hav­ing to do with fed­er­al over­sight of her­ring fish­ing — but the court’s de­ci­sions

Sen. Thom Tillis (R-NC) is push­ing back on the Biden ad­min­is­tra­tion’s plans for how it hy­po­thet­i­cal­ly would use its con­tro­ver­sial “march-in” au­thor­i­ty when drug prices be­come

The Eu­ro­pean Med­i­cines Agency gave its stamp of ap­proval for 77 new drugs in 2023, with on­col­o­gy med­ica­tions lead­ing the pack with the most pos­i­tive

Big Phar­ma is push­ing back on draft guid­ance pub­lished by the FDA this fall that aims to clar­i­fy how drug­mak­ers can com­mu­ni­cate with health­care providers about the

The FDA found that the use of GLP-1s to treat di­a­betes and obe­si­ty do not cause sui­ci­dal thoughts or ac­tions in a pre­lim­i­nary re­view of

The FDA is set­ting out to stream­line in­ter­na­tion­al reg­u­la­tions of gene ther­a­pies with a pi­lot pro­gram to re­view ap­pli­ca­tions along­side glob­al reg­u­la­to­ry part­ners, an agency

The FDA is clar­i­fy­ing in­stances where gener­ic drug ap­pli­cants can re­quest that the agency re­con­sid­er an ap­pli­ca­tion, ac­cord­ing to an up­dat­ed draft guid­ance pub­lished Wednes­day.

As Con­gress con­sid­ers whether to shift away from or­phan drug in­cen­tives that have pro­vid­ed a wind­fall for in­dus­try in some cas­es, a new FDA and

FDA Com­mis­sion­er Robert Califf has se­lect­ed Eliz­a­beth “EJ” Jung­man, who cur­rent­ly serves as the di­rec­tor of the Of­fice of Reg­u­la­to­ry Pol­i­cy in CDER, as his

Sen­ate De­moc­rats on the health com­mit­tee are press­ing in­haler man­u­fac­tur­ers over their high US prices and how they’ve used the patent sys­tem to main­tain ex­clu­siv­i­ty,