An­throp­ic up­end­ed soft­ware pro­gram­ming with the run­away suc­cess of the cod­ing agent Claude Code. For its next act, the AI lab is turn­ing its at­ten­tion...

Ab­b­Vie and Gen­mab’s bis­pe­cif­ic an­ti­body Ep­kin­ly suc­ceed­ed in com­bi­na­tion with a wide­ly used can­cer drug, bring­ing it one step clos­er to a po­ten­tial la­bel ex­pan­sion...

Vi­jay Ku­mar is leav­ing his role as act­ing di­rec­tor of CBER's Of­fice of Ther­a­peu­tic Prod­ucts and will soon con­sid­er op­tions both in­side and out­side the...

Ahead of an FDA ad­vi­so­ry com­mit­tee meet­ing to dis­cuss lift­ing re­stric­tions on sev­en pop­u­lar pep­tides, agency re­view­ers have rec­om­mend­ed against in­clud­ing the pep­tides on a...

The FDA has cho­sen the first sev­en com­pa­nies to par­tic­i­pate in its pi­lot PreCheck pro­gram, a group that in­cludes large drug­mak­ers Eli Lil­ly and Re­gen­eron...

A con­gres­sion­al com­mit­tee has opened an in­quiry in­to Bris­tol My­ers Squibb and Pfiz­er's use of clin­i­cal tri­al sites in Chi­na, in­clud­ing fa­cil­i­ties that the com­mit­tee's...