CHMP Backs Novo Nordisk’s Semaglutide for MASH, Opening Door to EU Approval

As reported on MedicalXpress, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for several therapies this cycle, including a conditional endorsement…

Continue Reading CHMP Backs Novo Nordisk’s Semaglutide for MASH, Opening Door to EU Approval

Aucta Pharmaceuticals Launches PYQUVI, Expands Branded‑Generic Portfolio in Rare Disease Care

As reported on the Manila Times, Aucta Pharmaceuticals has officially introduced PYQUVI™ (deflazacort) oral suspension 22.75 mg/mL, marking the company’s entry into the U.S. commercial branded‑generic market. The therapy, released…

Continue Reading Aucta Pharmaceuticals Launches PYQUVI, Expands Branded‑Generic Portfolio in Rare Disease Care

Datroway Receives U.S. Priority Review for First‑Line Treatment of Metastatic Triple‑Negative Breast Cancer

In a recent statement by AstraZeneca, AstraZeneca and Daiichi Sankyo’s antibody‑drug conjugate Datroway (datopotamab deruxtecan) has been granted Priority Review by the U.S. Food and Drug Administration (FDA) for use…

Continue Reading Datroway Receives U.S. Priority Review for First‑Line Treatment of Metastatic Triple‑Negative Breast Cancer

Moderna and Recordati Partner on mRNA‑3927 for Propionic Acidemia: Clinical Development Advances Toward Pivotal Readout

As reported on BioSpace, Moderna has entered a commercialization agreement with Recordati valued at up to $160 million to support late‑stage development and future market introduction of mRNA‑3927, an investigational…

Continue Reading Moderna and Recordati Partner on mRNA‑3927 for Propionic Acidemia: Clinical Development Advances Toward Pivotal Readout

New Immunotherapy Strategy Targets Tumor ‘Bodyguards,’ Shows Powerful Results in Preclinical Cancer Models

As reported on ScienceDaily, a research team at the Icahn School of Medicine at Mount Sinai has unveiled a novel immunotherapy that tackles metastatic cancer by attacking the tumor’s protective…

Continue Reading New Immunotherapy Strategy Targets Tumor ‘Bodyguards,’ Shows Powerful Results in Preclinical Cancer Models

FDA Places Clinical Holds on REGENXBIO’s MPS Gene Therapy Programs After Tumor Detected in Trial Participant

As reported on drugs.com, REGENXBIO has disclosed that the U.S. Food and Drug Administration has halted clinical testing of its investigational gene therapies RGX‑111 and RGX‑121, both being developed for…

Continue Reading FDA Places Clinical Holds on REGENXBIO’s MPS Gene Therapy Programs After Tumor Detected in Trial Participant

FDA Places Clinical Hold on REGENXBIO’s MPS Gene Therapy Programs After Tumor Case Review

As reported on Drugs.com, REGENXBIO has announced that the U.S. Food and Drug Administration (FDA) has halted clinical testing of its investigational gene therapies RGX‑111 and RGX‑121, two programs targeting…

Continue Reading FDA Places Clinical Hold on REGENXBIO’s MPS Gene Therapy Programs After Tumor Case Review

Moderna Partners With Recordati to Advance mRNA Therapy for Propionic Acidemia

As reported on BioSpace, Moderna has entered a commercialization partnership with Italy‑based Recordati to support the development of mRNA‑3927, an investigational mRNA therapy for propionic acidemia (PA). The agreement, announced…

Continue Reading Moderna Partners With Recordati to Advance mRNA Therapy for Propionic Acidemia

NEJM Publishes Phase 1/2 Results for Denali Therapeutics’ Brain‑Penetrant Hunter Syndrome Therapy

A newly published Phase 1/2 study in The New England Journal of Medicine, and reported on by the Manila Times, highlights promising early results for tividenofusp alfa (DNL310), Denali Therapeutics’ investigational…

Continue Reading NEJM Publishes Phase 1/2 Results for Denali Therapeutics’ Brain‑Penetrant Hunter Syndrome Therapy

GLP-1 Therapies Emerge as Key Tools in CKD Prevention—But Long-Term Success Hinges on Patient Engagement

As reported on Healio, glucagon-like peptide-1 (GLP-1)–based therapies are rapidly reshaping the landscape of diabetes and chronic kidney disease (CKD) management. Originally developed for glycemic control, these agents now play…

Continue Reading GLP-1 Therapies Emerge as Key Tools in CKD Prevention—But Long-Term Success Hinges on Patient Engagement

How Shenqi Dihuang Decoction May Target Key Pathways in IgA Nephropathy: New Mechanistic Insights

Immunoglobulin A nephropathy (IgAN) remains one of the most common primary glomerular diseases worldwide, yet effective treatments are limited. A new study, recently published in Frontiers, offers fresh evidence that…

Continue Reading How Shenqi Dihuang Decoction May Target Key Pathways in IgA Nephropathy: New Mechanistic Insights

ImmunityBio Reports Encouraging Evidence That ANKTIVA Enhances Immune Recovery in NSCLC When Paired With Checkpoint Inhibitors

As reported on Business Wire, ImmunityBio has released new clinical findings suggesting that its interleukin‑15 superagonist, ANKTIVA® (nogapendekin alfa inbakicept), may help restore immune function and improve survival outcomes in…

Continue Reading ImmunityBio Reports Encouraging Evidence That ANKTIVA Enhances Immune Recovery in NSCLC When Paired With Checkpoint Inhibitors

FDA Approves First Treatment for Stem Cell Transplant–Associated Thrombotic Microangiopathy

The U.S. Food and Drug Administration (FDA) has approved Yartemlea (narsoplimab‑wuug), marking the first authorized therapy for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA) in adults and children aged 2…

Continue Reading FDA Approves First Treatment for Stem Cell Transplant–Associated Thrombotic Microangiopathy