Reframe Daily: RSV approval, PCSK9 pill, semaglutide breakthrough

1

Merck’s RSV antibody Enflonsia wins FDA approval for infants

Full U.S. licensure means a simpler, single-dose option to protect newborns this coming RSV season.

😊😊😊😊😊 (FDA-approved/marketed)

2

Avidity, FDA strike accelerated-approval pathway for FSHD therapy del-brax

A clear regulatory route speeds first-in-class RNA therapy toward patients with a debilitating muscular dystrophy.

😊😊😊 (Phase 2 or agreed filing path)

3

Merck’s first-in-class oral PCSK9 inhibitor meets two Phase 3 endpoints

Successful late-stage trials set the stage for a convenient cholesterol-lowering pill that could rival injectable PCSK9 antibodies.

😊😊😊😊 (Late Phase 3 or NDA/BLA in sight)

4

Metsera’s once-monthly amylin analog shows “marked efficacy” in early obesity study

First human data hint at a durable, alternative mechanism to GLP-1s for weight loss.

😊😊 (Phase 1/early human)

1

Phase 3 Trial of Semaglutide in Metabolic Dysfunction–Associated Steatohepatitis

Weekly semaglutide cleared liver inflammation in 63 % of MASH patients and improved fibrosis in 37 %, the first large study to hit both targets — a big step toward the first approved drug for NASH/MASH. 

😊😊😊😊 (pivot-phase data; NDA likely in 6-12 mo)

2

Navigational Bronchoscopy vs. CT-guided Needle Biopsy for Peripheral Lung Nodules (VERITAS)

The bronchoscopic approach was non-inferior for diagnostic accuracy but cut pneumothorax rates from 28 % → 3 %, offering a safer option that most U.S. centers can adopt immediately. 

😊😊😊😊😊 (devices & know-how already on market)

3

Omitting Regional Nodal Irradiation after Response to Neoadjuvant Chemotherapy in Node-Positive Breast Cancer

In women whose lymph nodes convert to negative after chemo, skipping nodal irradiation did not worsen recurrence or survival, meaning thousands could avoid extra radiation toxicity right away. 

😊😊😊😊😊 (practice change implementable now)