The US FDA New Drug Approvals in May 2026

Shots: The US FDA approved eight therapies in May 2026 across oncology, cardiovascular disease, infectious diseases, anesthesia, and antimicrobial resistance, reflecting continued regulatory momentum in addressing both rare and prevalent diseases. Key approvals included Veppanu (breast cancer), Beqalzi (mantle cell lymphoma), Baxfendy (hypertension), Hepcludex (HDV infection), Decnupaz (BPDCN), Zaynich (cUTI), Cypsedo (general anesthesia), and Xocova (COVID-19 PEP). Overall, May 2026 underscored the FDA’s commitment to advancing innovative medicines, precision therapies, and expanded patient access,…

ByDipanshu Dixit1 day ago

NEWS

LIB Therapeutics Receives the FDA Approval for Lerochol (Lerodalcibep-liga) for Adults with Elevated LDL Cholesterol

Shots: The US FDA has approved Lerochol as an LDL-C lowering therapy for adults with hypercholesterolemia, including HeFH; US launch as a PFS is expected in spring 2026, with an autoinjector later in 2026, while EMA approval is anticipated in Jun 2026 alongside additional global regulatory filings Approval was supported by the global P-III (LIBerate) trial, enrolling over 2,900 CVD patients and without…

ByDipanshu DixitDecember 12, 2025

INSIGHTS+

Top Performing Drug – Ozempic (September Edition)

Shots: PharmaShots’ next episode on the top-performing drug of the month, based on 2021 revenue, focuses on Ozempic, a drug developed and marketed by Novo Nordisk Ozempic (semaglutide) is a human GLP-1 receptor agonist (or GLP-1 analog). It, when taken along with diet and exercise, is proven to improve blood sugar in adults with type 2…

BySenior EditorSeptember 27, 2023

VIEWPOINTS

Ruud Dobber Shares Insights from RWE Data from the REVEAL-CKD Presented at the ERA-EDTA’23

Shots: Ruud talked about the key findings from the new RWE data at ERA-EDTA'23 which demonstrated the staggeringly low rate of diagnosis in chronic kidney disease (CKD) He then discussed the risk factors of CKD and the urgent need to act on the growing global burden of CKD and how this disease is impacting the…

BySenior EditorSeptember 25, 2023

THOUGHTSPOT

Role of Wearables in Cardiovascular Domain

The heart is the muscular organ that pumps blood throughout the body. A group of diseases that affect the heart and blood vessels of the body comes under cardiovascular disease (CVD). Heart disease is globally the major cause of death (~17.3M). Irregular heart functions can lead to heart arrhythmia, heart attack, myocardial infarction, and other…

BySaurabh ChaubeyJuly 12, 2022

The US FDA New Drug Approvals in May 2026

LIB Therapeutics Receives the FDA Approval for Lerochol (Lerodalcibep-liga) for Adults with Elevated LDL Cholesterol

Top Performing Drug – Ozempic (September Edition)

Ruud Dobber Shares Insights from RWE Data from the REVEAL-CKD Presented at the ERA-EDTA’23

Role of Wearables in Cardiovascular Domain

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