Europe to review safety data for Eisai-Biogen Alzheimer's drug
The European medicines regulator said on Friday it will review safety information for Eisai and Biogen's Leqembi, nearly ...
The American Journal of Managed Care8h
OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
Healio9h
FDA receives biologics license application for apitegromab in spinal muscular atrophy
A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...
Monthly Prescribing Reference7d
Nasal Spray Formulation of Bumetanide Under FDA Review
The NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.
STAT3d
How to protect HHS, FDA, NIH, and other health agencies from political interference
When politicians subordinate scientific institutions to electoral interests, they undermine immediate public health efforts ...
Rolling Out5d
Why the FDA says menthol cigarettes must go now
The Food and Drug Administration has ignited a heated debate with its latest review of menthol cigarettes, revealing ...
SCOTUSblog11d
Menthol vapes and forum shopping, FDA tobacco control comes before justices
The Supreme Court will hear oral arguments on Tuesday in a clash over whether a North Carolina-based company can challenge the Food and Drug Administration’s denial of its application to market ...
Renal & Urology News4d
Nasal Spray Formulation of Bumetanide Under FDA Review
A Prescription Drug User Fee Act target date of September 14, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for review the New Drug Application ...
Monthly Prescribing Reference12d
FDA Extends Review of Elamipretide for Barth Syndrome
The new Prescription Drug User Fee Act target date is April 29, 2025. The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elamipretide for ...
Cure Today11d
The FDA Accepts a BLA for RP1 Plus Opdivo in Advanced Melanoma
The FDA has accepted a BLA for treatment with RP1 in combination with Opdivo for patients with advanced melanoma who have ...
FDA approves first new type of pain medication in 25 years
A new pain relief drug, suzetrigine, is a prescription pill that’s taken every 12 hours after a larger starter dose. It will ...
JD Supra3h
How New Executive Orders May Affect FDA’s Medical Device Operations
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...