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 Care2h
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 ...
Healio3h
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 ...
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 ...
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 ...
SCOTUSblog10d
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 ...
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 ...
FDA pauses updates on foodborne outbreak probes as health agencies regroup on communications
The Trump administration's "short pause" on communications, expected to end on Feb. 1, has affected FDA updates on food ...
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-of-its-kind nasal spray for severe depression
Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the ...
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.
HealthDay on MSN11d
FDA Approves Spravato Nasal Spray for Treatment-Resistant Depression
Approval of Spravato, granted following FDA priority review, was based on the results of a randomized, double-blind, ...