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The sNDA for amikacin liposome inhalation suspension is supported by phase 3b ENCORE trial data, with a PDUFA date of January 28, 2027.

Aquestive has resubmitted its needle-free epinephrine film after an FDA rejection over usability, not efficacy. This FAQ covers what changed.

Stay updated with the latest healthcare breakthroughs, including Bayer's finerenone expanding to type 1 diabetes-associated CKD.

Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the FDA's recent approval of Bayer's finerenone in concomitant CKD and T1D.

The FDA has granted Priority Review to dersimelagon for EPP and XLP, setting a PDUFA date for late February 2027 as LEO Pharma completes its acquisition from Tanabe Pharma.

What lonvo-z is, how it works, and what a Priority Review designation means for the HAE gene-editing therapy.

Neal Bhatia, MD, weighs the newly approved Ameluz PDT regimen for sBCC against Mohs surgery, citing its 66% composite response rate.

Read 6 late-breaking updates from ERS Congress 2026 that clinicians managing respiratory disease should know.

The resubmission follows an FDA Complete Response Letter and cites human factors data showing pouch-opening time fell from 17 to 3 seconds.

The approval, backed by FINE-ONE data showing a 28% UACR reduction at 6 months, is the first new CKD treatment for this group in 3 decades.

In this Q&A, Armand explains why eczema visits spike during wildfire smoke events and how allergic patients can protect themselves.

In this Q&A, Leon Kircik, MD, discusses challenging watch-and-wait for molluscum contagiosum with berdazimer gel, 10.3%, at LEADderm 2026.

New ASH guidelines recommend higher ferritin thresholds to improve the diagnosis of iron deficiency across key populations.

In this Q&A, Alysse Wurcel, MD, translates qualitative barriers into 8 concrete tactics healthcare practices can use to expand penicillin allergy delabeling.

In this feature, several leaders in the dermatology space were asked how far we have come and where the field is headed in precision medicine.

Boehringer Ingelheim halted EASi-KIDNEY after a DMC found data did not support a meaningful clinical benefit on the trial's primary endpoint.

Wuyts, of University Hospitals Leuven discusses interim FIBRONEER-ON open-label extension data showing nerandomilast's favorable safety profile.

BEACON-HCC offers a new approach to HCC treatment allocation, with key differences from the updated BCLC framework.

Jim Blando, PhD, of Old Dominion University, explains why allergic patients' lung function dropped most 1 year after wildfire smoke exposure.

Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss Beta Bionics' new insulin patch pump, expected to be commercialized in Q1 2027.

Atacicept also stabilized eGFR and matched placebo on safety, with a full FDA approval filing planned for Q4 2026.

A multi-site qualitative study identifies communication, language, and access barriers standing in the way of removing incorrect penicillin allergy labels.

However, Connect Biopharma's phase 2 Seabreeze STAT Asthma trial's primary treatment-failure end point missed statistical significance.

Arrowhead's ARO-DIMER-PA cut PCSK9 by 72% and APOC3 by 88% with single doses, driving LDL-C and triglyceride reductions in mixed hyperlipidemia.

FDA accepts Cogent's bezuclastinib NDA for advanced systemic mastocytosis, backed by APEX trial data showing durable, high-rate responses.




















































































