Wegovy Approved to Treat MASH With Moderate to Advanced Fibrosis

The FDA has approved semaglutide in conjunction with diet and exercise for the treatment of MASH with moderate to ...

AUGUST 20, 2025

Low-Dose Aspirin During Pregnancy for Women With IBD, Guselkumab for Moderate to Severe UC

The first study in The Regueiro Report this month focuses on the intersection of pregnancy and inflammatory bowel ...

APRIL 24, 2025

FDA Approves Opdivo With Yervoy for Unresectable or Metastatic Hepatocellular Carcinoma

The FDA has approved nivolumab (Opdivo, Bristol Myers Squibb) with ipilimumab (Yervoy, Bristol Myers Squibb) for ...

APRIL 23, 2025

Vyloy With Chemotherapy Approved for Gastric or Gastroesophageal Junction Adenocarcinoma

The FDA has approved zolbetuximab for the first-line treatment of adults with advanced gastric or gastroesophageal ...

NOVEMBER 4, 2024

FDA Approves Next-Gen mt-sDNA test, Cologuard Plus

The FDA has approved the next-generation of the multitarget stool DNA test Cologuard (Exact Sciences).

OCTOBER 9, 2024

FDA Approves Fourth Ustekinumab Biosimilar, Otulfi

The FDA has approved ustekinumab-aauz (Otulfi, Fresenius Kabi/Formycon), a biosimilar to ustekinumab (Stelara, ...

OCTOBER 7, 2024

FDA Approves Guselkumab for UC

The FDA has approved guselkumab (Tremfya, Janssen) for patients with moderately to severely active ulcerative ...

SEPTEMBER 12, 2024

FDA Approves Amneal Propofol Injectable Emulsion Single-Dose Vials

Propofol, used for the induction and maintenance of anesthesia and sedation, is currently on the ASHP drug ...

AUGUST 26, 2024

MASH Therapy Pipeline Growing, With a Mix of Results

After years without drug treatments for metabolic dysfunction–associated steatohepatitis, recently data have ...

AUGUST 22, 2024

FDA Approves Seladelpar for Primary Biliary Cholangitis

The FDA has granted accelerated approval to seladelpar (Livdelzi, Gilead) in combination with ursodeoxycholic acid ...

AUGUST 21, 2024

FDA Approves Vonoprazan for NERD

The FDA has approved vonoprazan (Voquezna, Phathom) 10-mg tablets for use in patients with nonerosive reflux ...

JULY 19, 2024

FDA Approves Pyzchiva Biosimilar to Stelara

Pyzchiva was approved for all indications of its reference biologic; the FDA provisionally determined that ...

JULY 3, 2024