Browsing Tag
U.S. Food and Drug Administration
166 posts
Could three FDA submissions turn bezuclastinib into a rare disease and oncology launch engine?
Cogent’s AdvSM NDA gives COGT a third bezuclastinib FDA submission, sharpening its KIT-driven disease franchise and late-2026 launch story.
Could nomlabofusp become the rare disease catalyst that revalues Larimar?
Larimar’s rolling BLA and nomlabofusp data sharpen LRMR’s rare disease biotech story around Friedreich’s ataxia, frataxin and accelerated approval.
Why CGTX stock could draw attention after FDA alignment on DLB psychosis
Cognition Therapeutics’ FDA alignment gives zervimesine a clearer DLB psychosis path, sharpening CGTX’s dementia drug development and stock story.
Otsuka Holdings expands neuropsychiatry strategy with $1.23bn Transcend deal structure
Find out how Otsuka’s Transcend Therapeutics acquisition could reshape PTSD drug development and investor sentiment around TSE: 4578.
How a first-in-class HDV approval could support Gilead Sciences’ long-term antiviral portfolio
Find out how Hepcludex approval could strengthen Gilead Sciences’ antiviral portfolio and reshape HDV care in the U.S.
Could engineered pig hearts become the next major frontier in biotechnology investing?
Find out how United Therapeutics’ FDA-cleared UHeart trial could reshape engineered organ transplants and investor expectations.
Aldeyra Therapeutics brings biotech CFO experience to board amid ALDX regulatory reset
Find out how Aldeyra Therapeutics’ new board appointment could shape ALDX stock sentiment, FDA strategy and reproxalap’s next chapter for investors now.
Why TEM stock sentiment could hinge on Tempus AI’s FDA-approved diagnostics expansion
Find out how Tempus AI’s xT CDx approval could strengthen TEM stock sentiment, oncology diagnostics growth, and ADLT pricing strategy.
Why Joenja’s pediatric expansion could strengthen Pharming Group’s long-term commercial runway
Find out how Pharming’s Joenja FDA review could affect PHAR stock sentiment, pediatric APDS access, and rare-disease revenue growth.
ImmunityBio targets U.S. BCG shortage with exclusive Tokyo-172 agreement and FDA pathway plan
BCG supply is still a U.S. bladder cancer bottleneck. ImmunityBio’s Tokyo deal could widen access, if regulators move with it.