Curated news and analysis on clinical trials, drug approvals, and medical research.
Dyne Therapeutics is preparing a U.S. Accelerated Approval submission for z-rostudirsen in Duchenne muscular dystrophy and gearing up for a Phase 3 trial of z-basivarsen in myotonic dystrophy, while scaling operations to support potential commercialization.
New research links GLP-1 drugs like Ozempic to increased scurvy risk through appetite suppression and poor nutrition. University of Florida researchers are testing a GLP-1 implant for obese cats as feline obesity affects nearly 60% of US cats.
Genentech announced positive Phase II results for petrelintide, showing up to 10.7% mean weight loss versus 1.7% placebo at week 42 in people with overweight and obesity, with placebo-like tolerability.
South Africa is working to identify local manufacturers for lenacapavir, a twice-yearly injectable HIV prevention drug that showed near-perfect efficacy in clinical trials. Kenya has already received 21,000 doses of the medication.
Researchers at the National University of Singapore have identified protein tyrosine phosphatase 1B (PTP1B) as a molecular switch that regulates immunogenic cell death in cancer cells, offering a new target for chemoimmunotherapy development.
New research reveals how GLP-1 receptor agonists promote pancreatic health through gene expression changes and interact bidirectionally with gut microbiome, while real-world users report unexpected lifestyle changes alongside weight loss.
Outlook Therapeutics conducted a Type A meeting with the FDA to discuss the December 30, 2025 Complete Response Letter for ONS-5010/LYTENAVA™, focusing on substantial evidence of effectiveness and potential regulatory paths forward.
Genentech announced positive Phase II results for CT-388, a dual GLP-1/GIP receptor agonist, showing 22.5% placebo-adjusted weight loss at 48 weeks in people with obesity. The treatment was well-tolerated with low discontinuation rates.
Roche announced positive phase II results for obesity drug petrelintide showing 10.7% weight reduction, while the FDA set a December 18 decision date for breast cancer drug giredestrant.
The FDA has accepted Hansa Biopharma's Biologics License Application for imlifidase, a desensitization treatment for highly sensitized adult kidney transplant patients with positive crossmatch against deceased donors, with a PDUFA date of December 19, 2026.
The global nuclear medicine equipment market is projected to reach USD 10.00 billion by 2035, driven by rising cancer prevalence, technological advances in hybrid imaging systems, and AI integration in diagnostic workflows.
The FDA approved Tecvayli plus Darzalex Faspro for relapsed or refractory multiple myeloma after at least one prior therapy, and accepted a new drug application for iberdomide plus daratumumab and dexamethasone with a PDUFA date of August 17, 2026.
A Phase 1 trial of azer-cel, a CAR T-cell therapy using donor T-cells to target B-cells, is recruiting patients with progressive multiple sclerosis at eight U.S. sites. Separately, multiple randomized trials are comparing hematopoietic stem cell transplantation against high-efficacy disease-modifying therapies.
The FDA approved Tecvayli plus Darzalex Faspro for relapsed/refractory multiple myeloma in March 2026, and Darzalex Faspro-based quadruplet D-VRd for newly diagnosed transplant-ineligible patients in January 2026.
Children with obstructive sleep apnea face nearly twice the risk of contracting influenza or COVID-19 compared to controls, with increased vulnerability persisting even after adenotonsillectomy, according to a five-year study of over 1 million children.
AbbVie is testing venetoclax in a Phase 2 study for adults with relapsed or refractory Waldenström macroglobulinemia or lymphoplasmacytic lymphoma in Japan, aiming to expand the drug into rare blood cancers.
New clinical trials show single doses of psilocybin and LSD produce significant, lasting reductions in OCD and generalized anxiety disorder symptoms for up to 12 weeks, marking a potential shift from daily medication regimens.
The FDA has placed a partial hold on U.S. enrollment in a Phase 2 trial of del-desiran for myotonic dystrophy type 1, citing preclinical mouse data showing blood pressure drops not seen in humans, following a serious adverse event in earlier testing.
Pfizer reported positive Phase 3 trial results for BRAFTOVI combination therapy in metastatic colorectal cancer and received FDA Priority Review for HYMPAVZI expansion to hemophilia patients including children.
Two gene therapies for inherited eye diseases have progressed to clinical trials, with the FDA clearing Sanaregen's SVT-001 for Familial Drusen and SpliceBio treating its first patient in a Stargardt disease trial in Oxford.
