Legal questions swirl around FDA’s new expedited drug program, including who should sign off

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...

Exclusive: US FDA delays two drug reviews in new voucher program after safety, efficacy concerns

The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track ...

Takeaways from the AP's report on turmoil surrounding the FDA's new fast-track drug program

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...

Fast-tracked drug approvals pose safety risks, study shows

A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...

Emergent BioSolutions Receives U.S. FDA Approval on Supplemental New Drug Application for NARCAN® Nasal Spray to be Packaged in a New Carrying Case, Making Life-Saving ...

Since the U.S. prescription launch of NARCAN® Nasal Spray in 2016, the medicine has been trusted as a safe, effective way to reverse opioid ...
CURE

FDA Accepts Besremi Application for Essential Thrombocythemia

The FDA accepted Besremi's application for essential thrombocythemia, supported by SURPASS-ET and EXCEED-ET trial results, with a review target date of August 30, 2026. Essential thrombocythemia is a ...
Precision Medicine Online

Stoke Eyes 2027 New Drug Application for Dravet ASO After Fast Phase III Enrollment

The firm said at the JP Morgan Healthcare Conference that it wants zorevunersen to be approved as a disease-modifying ...
Rheumatology Advisor

FDA Drug Approval Decisions Expected in February 2026

Treatments for are allergic fungal rhinosinusitis, bipolar I disorder, Hunter syndrome, Leber hereditary optic neuropathy, ovarian cancer, and schizophrenia under review.