Browsing Tag
U.S. Food and Drug Administration
103 posts
Eli Lilly’s sofetabart mipitecan earns FDA Breakthrough Therapy status in platinum-resistant ovarian cancer
Eli Lilly's sofetabart mipitecan receives FDA Breakthrough Therapy designation in platinum-resistant ovarian cancer. Find out what this means for the ADC space.
Why Celcuity’s FDA priority review for gedatolisib could reset the breast cancer playbook
Celcuity earns FDA priority review for gedatolisib in advanced breast cancer. Find out what the July 2026 PDUFA date means for its market trajectory.
Why Philip Morris is betting big on the U.S. to drive its smoke-free future (NYSE: PM)
Explore how Philip Morris International’s $20B U.S. investment plan could reshape its smoke-free growth strategy, regulatory playbook, and industry leadership.
Camurus resubmits Oclaiz for FDA review as subcutaneous acromegaly therapy eyes June 2026 decision
Camurus's Oclaiz is back in FDA review for acromegaly. Find out what the June 2026 decision could mean for U.S. access and endocrine market disruption.
MoonLake Immunotherapeutics says FDA supports existing clinical data for sonelokimab, announces investor day amid strong market reaction
Find out how MoonLake Immunotherapeutics gained FDA support for its sonelokimab data and why investors are watching its 2026 regulatory path closely.
FDA green light fast-tracks Diamyd Medical’s type 1 diabetes verdict by nine months
Diamyd Medical accelerates its Phase 3 type 1 diabetes trial after FDA alignment. Find out what the earlier data readout means for approval prospects.
RevBio receives FDA approval to trial TETRANITE bone glue for dental ridge augmentation
RevBio gets FDA approval to trial TETRANITE in dental ridge augmentation. Find out how this adhesive could change implant workflows and cut surgery time.
What’s driving GH Research’s stock spike? FDA IND verdict looms for lead depression candidate
GH Research is set to update investors on its FDA IND filing and Phase 3 launch plans for GH001. Find out what this means for its future in depression treatment.
AstraZeneca, Daiichi Sankyo score tenth BTD for Enhertu in early HER2 disease
AstraZeneca and Daiichi Sankyo’s Enhertu earns FDA breakthrough tag in early breast cancer. Find out what this means for HER2 treatment strategy in 2025.
Corcept Therapeutics (NASDAQ: CORT) plunges as FDA rejects relacorilant for Cushing’s-related hypertension therapy
Corcept shares nosedive after FDA rejection of relacorilant for Cushing’s syndrome-related hypertension. Find out what this means for the company’s future.