FDA Archives - PharmaDeviceNews

Why Hansa Biopharma’s ConfIdeS trial could reshape kidney transplant desensitization

Hansa Biopharma’s imlifidase faces a decisive FDA year as Phase 3 transplant data test whether desensitization can unlock donor access.

Datroway challenges chemotherapy in first-line TNBC. AstraZeneca and Daiichi Sankyo now face the real test: adoption, safety and access.

EP-NEC has no approved drug worldwide. Leads Biolabs now has to prove Opamtistomig can turn rare-tumor urgency into regulatory momentum.

BPH care needs options beyond pills and surgery. Butterfly Medical’s $21m raise puts its reversible prostate implant in the spotlight.

Insulin dosing is moving to the cloud. Glooko’s FDA clearance raises bigger questions on hospital workflow, safety, and scale.

FDA-grade evidence is getting bigger and harder to collect. OM1’s Hologic study shows how AI may change medtech submissions.

Alzheimer’s drugs need easier delivery. Eisai and Biogen now face an FDA timing test that could shape Leqembi’s access story.

Novo Nordisk has the first-mover pill. Eli Lilly has the growth aura. Oral obesity drugs are turning access into the next GLP-1 battleground.

TRUQAP has ODAC support, but toxicity and survival maturity still matter. AstraZeneca’s prostate cancer expansion now faces FDA’s final test.

Digital therapeutics struggled alone. Remepy and Merck KGaA are testing whether software works better when built into the drug itself.