Huyabio’s HBI-8000 and Opdivo Combination Shows Significant Benefit in Phase 3 Melanoma Study

As reported on Fierce Pharma, Huyabio has reported encouraging Phase 3 results for its investigational oral HDAC inhibitor, HBI-8000, when used alongside Bristol Myers Squibb’s immunotherapy Opdivo (nivolumab) in patients…

Continue Reading Huyabio’s HBI-8000 and Opdivo Combination Shows Significant Benefit in Phase 3 Melanoma Study

AtaiBeckley Completes Patient Dosing in Phase 2b Trial of VLS-01 for Treatment-Resistant Depression

As reported on PharmaBiz, AtaiBeckley has announced a key milestone in the development of its investigational depression therapy, VLS-01, with the final participant now dosed in the company’s Phase 2b…

Continue Reading AtaiBeckley Completes Patient Dosing in Phase 2b Trial of VLS-01 for Treatment-Resistant Depression

FDA Issues Complete Response Letter for Rivoceranib–Camrelizumab Combination in Advanced Liver Cancer

As reported by The Manila Times, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Elevar Therapeutics regarding its new drug application for the…

Continue Reading FDA Issues Complete Response Letter for Rivoceranib–Camrelizumab Combination in Advanced Liver Cancer

ISTH 2026: Long-Term Phase 3 Data Support Denecimig as a Flexible Prophylactic Option for Hemophilia A

As covered by Fairfax Times, Novo Nordisk has reported encouraging long-term findings for its investigational hemophilia A therapy denecimig (Mim8), with interim results from the Phase 3 FRONTIER4 extension study…

Continue Reading ISTH 2026: Long-Term Phase 3 Data Support Denecimig as a Flexible Prophylactic Option for Hemophilia A

FDA Grants Breakthrough Device Designation to Aurenar’s V-Link System for Preventing Cerebral Vasospasm After Brain Hemorrhage

As reported on MobiHealth News, the U.S. Food and Drug Administration (FDA) has awarded Breakthrough Device designation to Aurenar’s V-Link System, a noninvasive neuromodulation technology designed to help reduce cerebral…

Continue Reading FDA Grants Breakthrough Device Designation to Aurenar’s V-Link System for Preventing Cerebral Vasospasm After Brain Hemorrhage

GLP-1 Receptor Agonists Associated With Lower Cardiovascular and Inflammatory Risks in Hidradenitis Suppurativa

As reported on MedPage Today, large retrospective study suggests that glucagon-like peptide-1 (GLP-1) receptor agonists may offer broad health benefits for patients with hidradenitis suppurativa (HS), extending beyond their established…

Continue Reading GLP-1 Receptor Agonists Associated With Lower Cardiovascular and Inflammatory Risks in Hidradenitis Suppurativa

FDA Sets Early 2027 Review Deadline for Sarepta’s Duchenne Exon-Skipping Therapies Despite Confirmatory Trial Setback

As reported on BioSpace, Sarepta Therapeutics has reached an important regulatory milestone in its effort to secure traditional FDA approval for two Duchenne muscular dystrophy (DMD) treatments, Amondys 45 and…

Continue Reading FDA Sets Early 2027 Review Deadline for Sarepta’s Duchenne Exon-Skipping Therapies Despite Confirmatory Trial Setback

Nexviazyme Achieves Key Phase 3 Milestone in Infants With Pompe Disease, Sanofi Prepares FDA Expansion Filing

As reported on Tech Times, Sanofi has reported positive results from its Phase 3 Baby-COMET study evaluating Nexviazyme (avalglucosidase alfa) in infants with infantile-onset Pompe disease (IOPD), one of the…

Continue Reading Nexviazyme Achieves Key Phase 3 Milestone in Infants With Pompe Disease, Sanofi Prepares FDA Expansion Filing

FDA Clears Orca Bio’s Tregzi for Adults Undergoing Allogeneic Stem Cell Transplantation for Blood Cancers

As reported on PharmaBiz, the US Food and Drug Administration (FDA) has approved Orca Bio’s Tregzi, a precision-engineered cell therapy designed for use in matched-donor allogeneic hematopoietic stem cell transplantation…

Continue Reading FDA Clears Orca Bio’s Tregzi for Adults Undergoing Allogeneic Stem Cell Transplantation for Blood Cancers

Ascletis Advances Obesity Pipeline With Two FDA IND Filings for Long-Acting Injectable Candidates

As reported on PharmaBiz, Ascletis Pharma has announced the submission of two Investigational New Drug (IND) applications to the US Food and Drug Administration (FDA) for experimental obesity treatments designed…

Continue Reading Ascletis Advances Obesity Pipeline With Two FDA IND Filings for Long-Acting Injectable Candidates

European Commission Expands Approval of Novartis Gene Therapy for Broader SMA Population

As reported on Pharmaceutical Technology, the European Commission has approved Novartis’ gene replacement therapy Itvisma (onasemnogene abeparvovec) for the treatment of children aged two years and older, adolescents, and adults…

Continue Reading European Commission Expands Approval of Novartis Gene Therapy for Broader SMA Population