Browsing Tag
U.S. Food and Drug Administration
117 posts
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.
Harbour BioMed FDA IND clearance puts HBM7004 into the clinical spotlight as bispecific oncology race intensifies
Harbour BioMed has FDA clearance, but HBM7004 must now prove whether its B7H4xCD3 design can translate platform science into clinical value.
The a2 Milk Company recalls U.S. infant formula batches as cereulide detection sparks market sell-off
The a2 Milk Company faces investor scrutiny after a U.S. infant formula recall. Read how the risk could affect brand trust and strategy.
The a2 Milk Company recalls U.S. infant formula batches as cereulide risk raises supply-chain questions
Infant formula trust is fragile. The a2 Milk Company recall shows how one ingredient risk can become a wider supply-chain test.
Why Arcutis Biotherapeutics, Inc. is targeting infant eczema with ZORYVE cream
Can ZORYVE cream unlock infant eczema markets? Discover how Arcutis Biotherapeutics, Inc. is reshaping dermatology strategy today.
BeOne Medicines wins FDA Priority Review for TEVIMBRA in HER2-positive GEA as ONC stock faces trial-to-approval test
BeOne has survival data and FDA momentum. The bigger question is whether TEVIMBRA can change first-line HER2-positive GEA care.
Medtronic expands cardiac ablation ambitions as Sphere-9 gains FDA Breakthrough Device pathway for VT
Medtronic’s Affera push is no longer just an AFib story. VT data may decide whether Sphere-9 becomes a broader ablation platform.