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…

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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…

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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…

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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…

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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…

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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…

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Sonelokimab Shows Sustained One-Year Benefits in Hidradenitis Suppurativa, With Encouraging Early Results in Adolescents

As reported on Healio, new phase 3 data suggest that sonelokimab may offer durable disease control for patients with moderate to severe hidradenitis suppurativa (HS), with more than two-thirds of…

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Grifols Starts Phase 3 Trial for a New, More Convenient Alpha-1 Treatment
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Grifols Starts Phase 3 Trial for a New, More Convenient Alpha-1 Treatment

What Happened? The healthcare company Grifols announced in a recent press release that it has enrolled and dosed the very first patient in a new Phase 3 clinical trial called…

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Investigational Tango–Revolution Drug Combination Shows Encouraging Early Activity in Pancreatic Cancer

Early Clinical Results Highlight Potential New Treatment Strategy As reported on STAT News, a novel investigational drug combination developed through a collaboration between Tango Therapeutics and Revolution Medicines has demonstrated…

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FDA Expands Risankizumab Approval to Pediatric Patients With Plaque Psoriasis and Psoriatic Arthritis

As reported on Becker's Hospital Review, the FDA has approved risankizumab (Skyrizi) for use in children and adolescents aged 6 years and older with moderate-to-severe plaque psoriasis who are appropriate…

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