A key Re­pub­li­can con­gress­man asked the Trump ad­min­is­tra­tion to re­strict the stream of mon­ey in­to Chi­na’s biotech sec­tor, threat­en­ing to squelch the deal­mak­ing that’s be­come big busi­ness for some US in­vest­ment com­pa­nies and large phar­ma.

Rep. John Moole­naar (R-MI) told Trea­sury Sec­re­tary Scott Bessent in a let­ter Thurs­day that the de­part­ment should add biotech­nol­o­gy to one of the sec­tors pro­hib­it­ed from re­ceiv­ing out­bound US in­vest­ment un­der the COINS Act. Signed in De­cem­ber 2025, the law re­stricts cer­tain tech­nolo­gies in Chi­na, and oth­er se­lect coun­tries, from re­ceiv­ing US dol­lars.

Moole­naar, who chairs the Se­lect Sub­com­mit­tee on Chi­na, wrote that the US and the Asian na­tion are “en­gaged in a fierce biotech­nol­o­gy com­pe­ti­tion" that has “cru­cial im­pli­ca­tions for our na­tion­al and eco­nom­ic se­cu­ri­ty as well as for the fu­ture of health­care and the se­cu­ri­ty of Amer­i­can med­ical da­ta.”

Bio­haven CEO Vlad Coric fi­nal­ly had the at­ten­tion of the FDA, and most im­por­tant­ly, Com­mis­sion­er Mar­ty Makary.

In late April, af­ter the com­pa­ny’s spin­ocere­bel­lar atax­ia drug had been re­ject­ed last year, Coric had won a meet­ing with the com­mis­sion­er’s of­fice to talk about a path for­ward for the rare dis­ease drug. But it didn’t go as planned.

Coric pitched sev­er­al op­tions as a way for­ward, in­clud­ing the FDA’s new plau­si­ble mech­a­nism. He al­so of­fered up a new analy­sis us­ing Bayesian sta­tis­tics, which Makary had ad­vo­cat­ed for at the be­gin­ning of the year.

But noth­ing seemed to steer Makary to­ward flex­i­bil­i­ty, ac­cord­ing to the sources, who spoke to End­points News on con­di­tion of anonymi­ty. Makary’s in­ten­tion was nev­er to pro­vide guid­ance, on­ly to lis­ten to the com­pa­ny’s con­cerns, a dif­fer­ent source said.

Bio­phar­ma's mood is­n't just run­ning on hope any­more.

The Bio­phar­ma Sen­ti­ment In­dex took an­oth­er step for­ward in Q2. The head­line sen­ti­ment score climbed to 96, up from 90 in Q1 and 78 in Q4 2025. In­dus­try sen­ti­ment is now with­in strik­ing dis­tance of the neu­tral (100) line for the first time since the four-year down­turn that fol­lowed the pan­dem­ic.

Pre­vi­ous im­prove­ments in sen­ti­ment were led by growth in ex­pec­ta­tions for the fu­ture. This quar­ter, cur­rent con­di­tions surged while the 12-month out­look bare­ly budged. It's a sign the re­cov­ery is show­ing up in the day-to-day.

Af­ter three FDA re­jec­tions dat­ing back to 2023, Out­look Ther­a­peu­tics said the agency has re­versed course re­gard­ing its re­for­mu­lat­ed ver­sion of Avastin for the eye con­di­tion known as wet AMD.

"The FDA con­clud­ed that sub­stan­tial ev­i­dence of ef­fec­tive­ness has been es­tab­lished" for the oph­thalmic re­for­mu­la­tion — to be known as Lyte­na­va — if ap­proved in the US, the com­pa­ny said in a state­ment Tues­day. Out­look held meet­ings with the agency in March and April, and said the FDA grant­ed the ap­peal as part of a for­mal dis­pute-res­o­lu­tion process through its Of­fice of New Drugs.

Out­look's stock OTLK rose more than 50% Tues­day morn­ing as the com­pa­ny said it plans to for­mal­ly re­sub­mit its ap­pli­ca­tion for Lyte­na­va next month. The FDA did­n't im­me­di­ate­ly re­spond to ques­tions on Out­look's com­ments.

Gilead has at long last won US ap­proval of its he­pati­tis D treat­ment Hep­cludex, which the FDA pre­vi­ous­ly re­ject­ed over is­sues with its man­u­fac­tur­ing and dis­tri­b­u­tion.

The drug, known gener­i­cal­ly as bule­vir­tide, treats chron­ic he­pati­tis D in­fec­tions in pa­tients who aren't yet in the lat­er stages of liv­er dam­age. Un­til now, there were no US-ap­proved treat­ments for the con­di­tion, the FDA said in an an­nounce­ment Fri­day.

Hep­cludex has been avail­able in Eu­rope for sev­er­al years. But the FDA re­ject­ed the drug in 2022 over is­sues with "man­u­fac­ture and de­liv­ery." It's un­usu­al for a drug­mak­er of Gilead­'s size to take this long to rem­e­dy those sorts of prob­lems, and Gilead has said lit­tle since then about what ex­act­ly the is­sues were.

The FDA has ap­proved the TROP2-di­rect­ed an­ti­body-drug con­ju­gate Da­troway as a first-line op­tion for triple-neg­a­tive breast can­cer, giv­ing Dai­ichi Sankyo and As­traZeneca a leg up over their com­peti­tor Gilead.

The ap­proval marks Da­troway’s third, af­ter it se­cured pri­or ap­provals in cer­tain HR-pos­i­tive, HER2-neg­a­tive breast can­cer and lung can­cer pa­tients. The lat­est ap­proval is for metasta­t­ic triple-neg­a­tive breast can­cer pa­tients who aren’t can­di­dates for check­point in­hibitors.

The de­ci­sion was based on re­sults from the TRO­PI­ON-Breast02 study, which showed that Da­troway helped ex­tend pa­tient lives by a m