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 ...
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 ...
infectiousdiseaseadvisor.com9h
Prefilled Syringe Presentation of Shingrix Under FDA Review
The FDA will review a new prefilled syringe presentation of Shingrix (zoster vaccine recombinant, adjuvanted).
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 ...
thecardiologyadvisor.com9h
Nasal Spray Formulation of Bumetanide Under FDA Review
The FDA has accepted for review the NDA for bumetanide nasal spray for edema associated with CHF, as well as hepatic and renal disease.
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 ...
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 ...
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 ...
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 ...
Replimune stock soars on FDA priority review for melanoma treatment
Shares of Replimune Group, Inc. (NASDAQ: NASDAQ:REPL) surged 17% following the announcement that the U.S. Food and Drug ...
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, ...