fda-and-biotech News
DBV Technologies Surges After Positive Peanut Allergy Patch Data
Shares jumped after the company's Phase 3 trial for its Viaskin Peanut patch met its primary endpoint, marking a crucial step toward regulatory submission.
Hologic Hits 52-Week High on Promising AI Cancer Detection Data
New clinical studies show Hologic's AI-powered mammography technology improves detection accuracy and streamlines radiologist workflows, boosting investor confidence.
AstraZeneca, Daiichi Sankyo Drug Wins Landmark US Approval
Enhertu, a potent antibody-drug conjugate, receives FDA nod as a first-line treatment for metastatic HER2-positive breast cancer, poised to become a new standard of care.
AstraZeneca Rises on Expanded FDA Approval for Cancer Drug Enhertu
The drug, developed with Daiichi Sankyo, is now approved as a first-line treatment for a form of metastatic breast cancer, opening a significant new market.
Aldeyra Stock Slides as FDA Extends Review of Key Dry Eye Drug
A three-month delay for lead candidate Reproxalap introduces new uncertainty for the pre-revenue biotech, threatening its entry into a competitive market.
Allogene Soars on Arbitration Win for Key Cancer Therapy
Shares jumped over 9% after a ruling solidified control over its pivotal Cema-Cel program, removing a critical legal overhang and boosting investor confidence in the biotech's CAR T pipeline.
Organogenesis Climbs on Clear FDA Path for Knee Osteoarthritis Drug
The regenerative medicine firm plans to file for approval of its ReNu therapy by the end of 2025, clarifying the regulatory path for a key asset targeting a multi-billion dollar market.
Milestone Pharma Soars 21% on Landmark FDA Drug Approval
The U.S. regulator approved the company's etripamil nasal spray, the first self-administered treatment for a common heart rhythm disorder, paving the way for commercialization.