The FDA has fi­nal­ized clin­i­cal guid­ance for psy­che­del­ic drug de­vel­op­ers and has sched­uled a pub­lic hear­ing on fu­ture ther­a­peu­tic use, adding reg­u­la­to­ry mo­men­tum to a...

The em­bat­tled ven­ture firm Ap­ple Tree Part­ners has suf­fered a loss in a Cay­man Is­lands court case against its main lim­it­ed part­ner.

A judge in...

The FDA is propos­ing a rule to change how fac­to­ries are reg­is­tered with the agency if they are mak­ing prod­ucts for the US mar­ket, as...

With the first half of 2026 of­fi­cial­ly in the books and an­oth­er earn­ings sea­son about to be­gin, a key ques­tion hangs over the bio­phar­ma in­dus­try...

Plus, news about In­sil­i­co, Ipsen, Q32 Bio, GSK’s Jem­per­li, Drug Farm and Pad­cev.

❌ FDA re­jects Tris Phar­ma’s nar­colep­sy drug: Its re­jec­tion let­tersaid that...