It was a chaot­ic year at the Food and Drug Ad­min­is­tra­tion. Thou­sands of staff left the agency. Lead­er­ship was un­sta­ble. Rou­tine drug re­views were de­layed, Com­mis­sion­er Mar­ty Makary re­port­ed­ly at­tempt­ed to in­ter­vene in an ap­proval de­ci­sion, and bi­o­log­ics chief Vinay Prasad over­rode vac­cine re­view­ers at least three times.

It’s un­clear how much that up­heaval con­tributed to the over­all num­ber of drugs ap­proved this year, which dipped slight­ly com­pared to 2024 and 2023 — de­spite Makary's claim in Ju­ly that it would be a record year for new ap­provals.

Still, many of the nov­el drugs be­fore the agency had un­event­ful re­views, and al­most all were re­viewed on time, ac­cord­ing to an End­points News analy­sis of the 53 new drugs and bi­o­log­ics ap­proved last year.

Tessera Ther­a­peu­tics, one of the biggest and most heav­i­ly fund­ed gene edit­ing star­tups, is plan­ning sweep­ing lay­offs that will im­pact 90 em­ploy­ees just as it be­gins its first clin­i­cal study, ac­cord­ing to work­er no­tices post­ed in two states.

The start­up at one time boast­ed a work­force of well over 300. Tessera pre­vi­ous­ly laid off about 13% of its staff in April 2024 and 17% in Ju­ly 2025, but didn’t dis­close spe­cif­ic head­counts at the time. The new lay­off num­ber was dis­closed on Wednes­day in WARN no­tices post­ed in Col­orado and Wash­ing­ton. The vast ma­jor­i­ty of the com­pa­ny’s work­force is based in Somerville, MA.

An­oth­er obe­si­ty biotech has en­tered the fray as tirzepatide and semaglu­tide fly off phar­ma­cy shelves.

Alveus Ther­a­peu­tics dis­closed a $159.8 mil­lion Se­ries A on Thurs­day morn­ing to cre­ate med­i­cines that dri­ve bet­ter qual­i­ty of weight loss and help pa­tients stay on treat­ment for longer du­ra­tions than No­vo Nordisk's We­govy and Eli Lil­ly's Zep­bound megablock­busters.

The biotech's lead can­di­date, ALV-100, will en­ter Phase 1b/2 this quar­ter. The drug was li­censed from Chi­na-based biotech Gmax and is ex­pect­ed to be dosed quar­ter­ly; Sino Bio­pharm has the Greater Chi­na rights. ALV-100 an­tag­o­nizes GIPR and ag­o­nizes GLP-1, which is a sim­i­lar ap­proach to Am­gen's much-an­tic­i­pat­ed Mar­i­Tide.

The Copen­hagen and Philadel­phia start­up al­so has a pre­clin­i­cal pipeline of prospects in the amylin space, an­oth­er mech­a­nism that's gained ground with re­cent da­ta read­outs.