FDA/CDC
FDA/CDC
FDA grants emergency use authorization to Johnson & Johnson COVID-19 vaccine
“The advantages of having a third vaccine, especially one that is a single shot and can be stored without special refrigeration requirements, will...
FDA/CDC
FDA approves cemiplimab-rwlc for NSCLC with PD-L1 expression
This approval “means physicians and patients have a potent new treatment option against this deadly disease.”
FDA/CDC
FDA clears novel daytime device for obstructive sleep apnea
The mouthpiece has electrodes located above and below the tongue.
News
FDA approves first drug that protects against chemo-induced myelosuppression
FDA/CDC
FDA approves orphan drug evinacumab-dgnb for homozygous FH
Indicated for homozygous familial hypercholesterolemia on top of other lipid-modifying therapy, Evkeeza (Regeneron) is a first-in-class inhibitor...
FDA/CDC
2021 ACIP adult schedule released
FDA/CDC
Mask mandates reduced COVID-19 hospitalizations
FDA/CDC
FDA okays new CAR T-cell treatment for large B-cell lymphomas
FDA/CDC
FDA curbs use of COVID-19 convalescent plasma, citing new data
FDA/CDC
FDA extends review period for anticipated Alzheimer’s drug
The PDUFA action date has been pushed forward from March 7 to June 7.