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FDA accepted Shionogi’s sNDA for cefiderocol for pediatric HABP/VABP and complicated UTI caused by certain Gram-negative bacteria.

The US FDA approved enlicitide (Lipfendra; Merck), the first oral PCSK9 inhibitor, to reduce LDL-C in adults with hypercholesterolemia, including HeFH.

FDA accepted Axsome’s NDA for AXS-12 for cataplexy in narcolepsy and set a PDUFA target action date of May 1, 2027.

Once-weekly subcutaneous lecanemab matched IV initiation exposure in early Alzheimer disease, but comparative clinical outcome data remain limited.

The 2026 global status report on cancer projects nearly 35 million new cases annually by 2050 and underscores urgent action on prevention and care access.

Phase 2 TRAPEDS-1 trial data show tralokinumab produced consistent pharmacokinetics and tolerability in children aged 6 to 11 years with moderate-to-severe atopic dermatitis.

Catch up on the 7 FDA drug approvals most relevant to primary care, including new options for hypertension, weight management, acne, and more.

FDA approval makes Differin Epiduo Acne Gel available OTC for patients aged 12 years or older with acne.

Clinicians discuss DKA risk, sick day plans, CGM use, and ketone testing in primary care.

The FDA recently approved the first generic baloxavir tablet for influenza treatment and postexposure prophylaxis in patients aged 5 years or older.

SLEEP 2026: A sleep expert discusses screening tools, referral pathways, and why sleep disorders matter for cardiometabolic health in primary care.

CGM prescribing in primary care was associated with lower HbA1c levels, fewer hospitalizations, and fewer ED visits among insulin-treated adults.

A primary care telehealth mindfulness program improved chronic low back pain and pain interference through 12 months in OPTIMUM.

FDA authorized a reduced-risk claim for 20 ZYN nicotine pouches for adults who switch completely from cigarettes.

A 10-week video-based cognitive rehabilitation program improved patient-set goals in adults with long COVID cognitive symptoms.

Recent FDA actions include updates on COVID-19 prophylaxis, ADHD, PTSD neuromodulation, and pediatric psoriasis and psoriatic arthritis care.

FDA approved roflumilast (Zoryve) cream 0.3% for plaque psoriasis in children as young as age 2, expanding the once-daily steroid-free topical indication.

A deep learning ECG model identified a high-risk group with a 7.0% annual sudden cardiac death rate in a new study.