fda-and-biotech News
Relay Therapeutics jumps 7% on FDA Breakthrough Therapy designation for breast cancer drug
Zovegalisib targets 40% of HR+/HER2- patients with PIK3CA mutations in underserved post-CDK4/6 market
AstraZeneca faces FDA rejection on Saphnelo lupus injection
Regulator issues Complete Response Letter for subcutaneous formulation as resubmission targets H1 2026 decision
Pharming shares plunge 16% after FDA rejects pediatric Joenja expansion
Regulators flagged dosing concerns and analytical issues, but existing approval for patients 12 and older remains intact
Aquestive shares fall on FDA Complete Response Letter for Anaphylm
Packaging and administration issues cited; resubmission expected Q3 2026
MannKind shares rise after FDA clears Afrezza label update
New dose conversion guidance for switching from injectable insulin could simplify prescribing and boost adoption of inhaled therapy
Guardant Health Stock Hits 52-Week High on Key FDA Approval
The regulator cleared Guardant's liquid biopsy as a companion diagnostic for a Pfizer colorectal cancer therapy, cementing a critical link between the test and treatment.
Janux Surges on $850M Cancer Therapy Deal with Bristol Myers Squibb
The collaboration to develop a next-generation solid tumor treatment provides major validation for Janux's TRACTr technology platform, sending shares soaring.
Erasca Shares Fall After Upsized $225 Million Stock Offering
The clinical-stage oncology company is capitalizing on a recent share price surge to fund its drug pipeline, a move that dilutes existing shareholders.