Browsing Tag
U.S. Food and Drug Administration
133 posts
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.
Genentech secures first ctDNA MRD-guided therapy approval for Tecentriq in MIBC
A cancer drug win is only half the story. Roche and Natera are testing whether ctDNA can decide who truly needs treatment.
Atrium Therapeutics (Nasdaq: RNA) Q1 results show cash runway and clinical urgency behind precision cardiology bet
Atrium has cash and RNA ambition. The harder test is whether heart-targeted delivery can turn rare cardiomyopathy science into clinical proof.
Rznomics gets FDA RMAT status for RZ-001, but can one liver cancer signal carry a platform story?
RNA editing has a regulatory opening in liver cancer. Rznomics now must prove RZ-001 can turn FDA momentum into durable clinical value.