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…
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…
Our friends at Heal Canada have launched the newest edition of their magazine, E3 Advocacy! Their digital publication focuses on the importance of patient advocacy, patient stories, and bridging knowledge…
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…
As reported on PharmaBiz, Merck has announced a new agreement with the ADAP Crisis Task Force (ACTF) aimed at improving access to its recently approved HIV treatment, Idvynso (doravirine/islatravir), for…
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…
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…
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…
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…
As reported on FiercePharma, the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Vertex Pharmaceuticals’ gene-editing therapy Casgevy (exagamglogene autotemcel), allowing the treatment to be used…
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…
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…
As reported on BioSpace, BridgeBio Pharma has reported new findings suggesting that its transthyretin (TTR) stabilizer, Attruby (acoramidis), may help preserve kidney function in patients with transthyretin amyloidosis cardiomyopathy (ATTR-CM),…
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…
As reported on BioSpace, Praxis Precision Medicines has received a three-month extension to the U.S. Food and Drug Administration’s review of relutrigine, its investigational therapy for rare genetic forms of…
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…
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…
According to STAT News, a major international clinical trial is about to begin in the Democratic Republic of the Congo (DRC) as health authorities respond to a rapidly escalating outbreak…
As reported on PharmaBiz, the U.S. Food and Drug Administration (FDA) has approved Lumvoa (veligrotug‑vvze), a new therapy developed by Viridian Therapeutics, for the treatment of thyroid eye disease (TED),…
As reported by PharmaBiz, Eli Lilly and Company has announced positive findings from its Phase 3 BRUIN CLL-322 trial evaluating pirtobrutinib (Jaypirca), a next-generation non-covalent Bruton tyrosine kinase (BTK) inhibitor,…
As reported on PharmaTimes, the United Arab Emirates has taken a significant step toward preventive neurology with the initiation of its first clinical trial guided by population-scale genomics. Spearheaded by…
As reported by Yahoo Finance, the U.S. Food and Drug Administration (FDA) has accepted for review two applications from Sandoz for generic versions of tirzepatide, a GLP-1–based therapy currently marketed…
As reported on FiercePharma, the U.S. Food and Drug Administration (FDA) has selected seven pharmaceutical and biotechnology companies to participate in its newly established PreCheck Pilot Program, an initiative aimed…
As reported on Healio, the U.S. Food and Drug Administration has broadened the indication for roflumilast cream 0.3% (Zoryve, Arcutis), allowing its use in children with plaque psoriasis as young…
A recent BBC report highlighted a forthcoming clinical trial examining puberty-suppressing medications in young people is being positioned by its proponents as a necessary step toward improving patient safety and…
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