Approvals
If the attention generated by BioSpace’s coverage of this landmark approval is any indication, Americans are hungry for non-opioid pain treatments that could help quell the still raging opioid epidemic.
Before garnering approval on Tuesday, Onapgo had been rejected twice by the FDA.
Robert F. Kennedy Jr.’s HHS nomination moves to a full Senate vote; Donald Trump’s tariff war sparks China-related concerns for biopharma; Pfizer, Merck and more announce Q4 and 2024 earnings; and the non-opioid painkiller space heats up as FDA approves Vertex’s Jounavx.
Robert F. Kennedy, Jr.—Trump’s pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA, particularly financial links between the two, which could indicate trouble for the user-fee model.
The approval of Axsome Therapeutics’ Symbravo for migraine with or without aura came alongside the greenlight for Vertex’s non-opioid treatment Journavx.
The approval continues the trend of GLP-1s expanding into indications outside of diabetes and weight loss.
Enhertu’s label expansion comes on the heels of the FDA’s approval of the partners’ Datroway for a related type of breast cancer.
The monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule for patients with Alzheimer’s, could help with Leqembi’s thus far disappointing uptake and sales.
Spravato’s monotherapy nod on Tuesday comes after a series of setbacks in the depression space.
Datroway, formerly known as Dato-DXd, significantly improved median progression-free survival in a Phase III study but failed to do so for overall survival.
PRESS RELEASES