CVMP opinions on veterinary medicinal products The Committee adopted a positive opinion for a marketing authorisation for Bexatil for the reduction of hyperglycaemia in cats…

Original title: “Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 July 2026”

The speedy clearance of Lipfendra is an important milestone for Merck and the result of a controversial voucher program put in place by former FDA commissioner Marty Makary.

Original title: “Merck wins first approval of a PCSK9 cholesterol pill”

The FDA today issued an Emergency Use Authorization (EUA) for Ivermectin Liquid for Horses (ivermectin oral solution) for the short-term prevention of New World screwworm (NWS) infestations (myiasis) in horses when administered within 24 hours of birth or at the time of initial wound care.

Original title: “FDA Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Screwworm in Horses”

We’re studying BCMA-directed ... unprecedented, but regulators are mandating randomized clinical trials to prove the benefit of these transformative therapies. I find it a big issue when you have a rare disease to have to do a large, randomized trial, which can only be ... We’re studying BCMA-directed therapies in this space, and there are excellent response rates and safety profiles that are unprecedented, but regulators are mandating randomized clinical trials to prove the benefit of these transformative therapies. I find it a big issue when you have a rare disease to have to do a large, randomized trial, which can only be ethically done in the upfront setting, because there’s nothing approved in the relapsed setting. Heather J. Landau, MD, discussed promising results of CAR T-cell therapy in light chain amyloidosis and the challenge of developing trials for this rare plasma cell disorder. ... Amyloid light-chain (AL) amyloidosis is a disease with a more challenging prognosis than other plasma cell disorders like multiple myeloma due to cardiac and other organ involvement and lack of survival benefit from many established myeloma therapies. However, using B-cell maturation antigen (BCMA) as a target has shown promise for chimeric antigen receptor (CAR) T-cell therapy, opening up a new single-infusion treatment approach in this rare disease setting. In the phase 1/2 NEXICART-2 trial (NCT06097832), the investigational CAR T-cell therapy NXC-201 What was really impressive and different was what we saw was the patients who were sickest coming into the trial, who had high light chains or obvious organ progression due to their relapsing disease, experienced significant clinical benefit very rapidly—as soon as the light chains were controlled. I can’t say I’ve witnessed that with any other therapy that I’ve given.

Original title: “Deep Responses Support Push for CAR T-Cell Therapy in AL Amyloidosis | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways”

Guidance expands treatment options for patients

Original title: “NICE backs finerenone for heart failure”

An inspection of a facility making Elevar’s rivoceranib uncovered deficiencies, leading the FDA to reject a combination therapy that includes the drug. The rebuff is the third strike for the partners after the agency issued manufacturing-related denials for the other drug in the combo.

Original title: “Manufacturing issues prompt FDA to reject Hengrui-Elevar filings for third time”

Celcuity’s first approved drug, Revtorpyk, is indicated for the second-line treatment of advanced HER2- breast cancer patients without PIK3CA mutations—a key use distinction that sets it apart from other PIK3/AKT blockers in the space, according to Jefferies.

Original title: “Celcuity wins breast cancer nod, securing ‘differentiated foothold’ in market”

Several children who had aggressive ... remained disease-free years after this treatment, according to an early-stage trial ... An illustration of a brain. ... Brain and spinal cord tumors are the deadliest childhood cancers, and treatments for the most aggressive forms often leave families with few options. Now an experimental immune-cell therapy has cleared an important early hurdle, with several children remaining cancer-free years after receiving the treatment. In an early-stage clinical trial published ... Several children who had aggressive recurrent brain tumors remained disease-free years after this treatment, according to an early-stage trial ... An illustration of a brain. ... Brain and spinal cord tumors are the deadliest childhood cancers, and treatments for the most aggressive forms often leave families with few options. Now an experimental immune-cell therapy has cleared an important early hurdle, with several children remaining cancer-free years after receiving the treatment. In an early-stage clinical trial published last week in Nature Medicine, researchers outline the treatment, called tumor-associated antigen (TAA) T cell therapy, which uses a patient’s own immune cells to target proteins that are commonly expressed by pediatric brain tumors. Such therapies could be especially valuable for brain cancers. Many tumors cannot be completely removed without risking brain regions that control essential functions such as breathing and movement, while the blood-brain barrier makes it difficult for drugs to reach tumors in effective doses. As a phase 1 clinical trial, the study’s main purpose was to determine a safe dose and identify potential side effects rather than to prove that the treatment works. “This study represents an important step toward developing safer and more effective T cell therapies for children with devastating brain cancers. We were encouraged to see lasting clinical benefit in several patients who otherwise had very few options,” said Catherine Bollard, chief research officer at Children’s National Hospital and a co-senior author of the study, in a press release. The treatment works by collecting T cells, the immune system’s frontline cancer-fighting cells, from a patient’s blood. These three had had aggressive cancers that had progressed despite years of chemotherapy, radiation and other existing treatments. More than two and a half years after receiving the T cell therapy, however, all three were reportedly alive, with no need for further treatment.

Original title: “Experimental immune therapy shows promise against deadly childhood brain cancer | Scientific American”

Some FDA-approved GLP-1s are being studied in clinical trials for the disease, but their results aren’t available yet. Experts caution against using experimental peptides for Long COVID. Despite the lack of research, some medical clinics and providers are advertising peptides as Long COVID therapies, and they are often hyped up on social media. GLP-1 medications are also peptides. Some people with Long COVID are “microdosing” them in hopes of treating their symptoms. One clinical trial is assessing the GLP-1 tirzepatide for the disease, while the National Institutes of Health RECOVER program will launch a trial on semaglutide later this year. With no drug specifically approved to treat Long COVID and medical care for the disease often lacking, many people turn to untested methods to manage their symptoms. Increasingly, that includes peptides, which are gaining prominence not only through social media, but also medical clinics and wellness websites explicitly pitching these compounds as Long COVID therapeutics. Currently, Paidas’s team is conducting additional research on SPIKENET’s pharmacokinetics — that is, how the substance interacts with the body — in animals. That’s “one of the last phases before we develop this for a human application” and conduct clinical trials, he said. “I’m committed to really seeing this through to develop a therapy.” Into this milieu come clinics and providers suggesting that peptide therapies can improve various Long COVID symptoms. The Sick Times found multiple examples of healthcare providers, medical clinics, and wellness websites explicitly describing various unapproved peptides as Long COVID treatments.

Original title: “Experimental peptides are being advertised for Long COVID. But the evidence is trailing behind. - The Sick Times”