September 16, 2023

Mul­ti­ple myelo­ma drug Blenrep and Duchenne mus­cu­lar dy­s­tro­phy ther­a­peu­tic Translar­na did not make the Eu­ro­pean Med­i­cines Agency’s cut for full mar­ket­ing au­tho­riza­tion, the agency an­nounced

Sev­er­al man­u­fac­tur­ers of over-the-counter cold med­i­cines have been named in a string of class ac­tion law­suits fol­low­ing an FDA ad­vi­so­ry com­mit­tee’s vote ear­li­er this week

What if the Mona Lisa or the Girl with a Pearl Ear­ring had dry, scaly patch­es on their skin? They do in Almi­rall’s “Atopic Mu­se­um,” cre­at­ed

Phar­ma is not ready for the fu­ture. On­ly 10% say they’re “fu­ture ready,” ac­cord­ing to a re­cent sur­vey of phar­ma­ceu­ti­cal lead­ers by In­de­gene. That’s a

Bris­tol My­ers Squibb and 2sev­en­ty bio said this week that a man­u­fac­tur­ing shut­down will trans­late to low­er-than-ex­pect­ed sales for their CAR-T cell ther­a­py Abec­ma in

The FDA on Fri­day re­leased new draft guid­ance that re­vers­es pri­or guid­ance and says that in­ter­change­able biosim­i­lars should no longer in­clude a de­scrip­tion of their

Nek­tar Ther­a­peu­tics has un­veiled up­dat­ed re­sults from a Phase Ib tri­al of its atopic der­mati­tis (AD) can­di­date, rezpe­galdesleukin, in the midst of a case against

Ab­cam founder Jonathan Mil­ner said he’d vote against Dana­her’s pro­posed buy­out of the bio­phar­ma tools sup­pli­er on Thurs­day, and the UK com­pa­ny ap­peared dumb­found­ed by

As Am­gen catch­es up with lead­ers in the bur­geon­ing obe­si­ty space, it’s un­der­scor­ing a “plat­form ap­proach” and shoot­ing for “broad op­tion­al­i­ty” in the de­sign of

Io­vance Bio­ther­a­peu­tics’ bid for ap­proval of its melanoma ther­a­py has been hit with its fourth year of de­lay, as FDA re­source con­straints forced the agency