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CHMP backs Acadia Pharmaceuticals' Daybue (trofinetide) for Rett syndrome on re-examination, advancing European approval
Small molecule, neurological, Rett syndrome, trofinetide, rare disease - Read more

United Therapeutics wins FDA premarket approval for LungFX device for end-stage lung disease donor assessment
Medical device, pulmonary, organ transplantation, ex vivo lung perfusion, end-stage lung disease - Read more

Viridian Therapeutics' Lumvoa (veligrotug-vvze) wins FDA approval for thyroid eye disease across active and chronic disease
Antibody, autoimmune, monoclonal antibody, thyroid eye disease, IGF-1R inhibitor - Read more

AstraZeneca, Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) wins EU approval for HER2-positive metastatic solid tumours across Ph2 trials
Antibody drug conjugate, cancer, monoclonal antibody, HER2-positive, solid tumors, tumor agnostic - Read more

AbbVie receives positive CHMP opinion for upadacitinib RINVOQ in severe alopecia areata treatment
Small molecule, autoimmune, regulatory, revenue impact - Read more

Nippon Shinyaku, Elixirgen Therapeutics enter option agreement for EXG-7001 Duchenne muscular dystrophy development and commercialization
Option agreement, rare disease, mRNA therapy, neuromuscular disease, commercialization - Read more

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AstraZeneca's (efzimfotase alfa) shows Ph3 efficacy over placebo in children with hypophosphatasia bone disease
Protein therapy, metabolic, enzyme replacement therapy, hypophosphatasia, rare bone disease, efzimfotase alfa - Read more

BridgeBio Pharma's (infigratinib) Ph3 shows significant growth and body proportionality gains in achondroplasia
Small molecule, skeletal disorder, FGFR inhibitor, achondroplasia, pediatric - Read more

Avecho Biotechnology's (cannabidiol) Ph3 trial for insomnia advances after positive interim analysis
Small molecule, neurological, cannabidiol, insomnia, phase III trial - Read more

Samsung Bioepis' SB27 (pembrolizumab) biosimilar meets primary endpoints in Ph1 and Ph3 trials for non-small cell lung cancer
Antibody, cancer, biosimilar, monoclonal antibody, non-small cell lung cancer, PD-1 inhibitor - Read more

Talawar Therapeutics plans $285M SPAC merger and PIPE, advancing eczema bispecific antibody
Autoimmune, bispecific antibody, atopic dermatitis, preclinical, immunology - Read more

Alopexx plans $30M IPO to fund infectious disease antibody and vaccine programs
Infectious disease, antibody, vaccine, clinical-stage - Read more

Lycia Therapeutics raises $75M Series D, advancing extracellular protein degrader pipeline
Autoimmune, protein degradation, clinical-stage, allergic diseases, platform technology - Read more

Leyden Labs raises $40M in funding to expand respiratory virus therapy development
Infectious disease, antibody, respiratory viruses, mucosal protection, platform technology - Read more

Ipsen to acquire Kartos Therapeutics for up to $1.75B, adding myelofibrosis candidate navtemadlin to oncology pipeline
Small molecule, hematologic oncology, strategic, major transaction - Read more

Scancell Holdings bids to acquire Neuphoria Therapeutics via reverse merger for Nasdaq listing access
Cancer vaccine, oncology, strategic, major transaction - Read more

Zymeworks to acquire Theravance for $929M, gaining approved COPD drug Yupelri and lucrative royalty deals
Small molecule, respiratory, major transaction, royalty - Read more

Roche launches Axelios 1 gene sequencing platform to compete with Illumina's NovaSeq X
Next-generation sequencing, oncology, competitive, strategic - Read more

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FDA rejects Sobi's NASP (pegadricase) application for uncontrolled gout due to manufacturing deficiencies
Protein therapy, metabolic, enzyme replacement, gout, uricase, pegylated recombinant enzyme - Read more

Evommune's (EVO756) Ph2b trial fails primary endpoint in chronic spontaneous urticaria, boosting Novartis's Rhapsido
Small molecule, autoimmune, MRGPRX2 antagonist, chronic spontaneous urticaria, atopic dermatitis - Read more

FDA schedules advisory committee for Capricor Therapeutics' DMD cardiomyopathy therapy ahead of August decision despite positive Phase 3 data
Cell therapy, rare disease, regulatory, competitive - Read more

FDA issues Form 483 with seven observations at Dr. Reddy's Hyderabad biologics plant
Biologics, regulatory, operational, quality control - Read more

BioCryst Pharmaceuticals shuts Alabama discovery facility, ends internal programs to save $30M via external partnerships
Small molecule, rare disease, cost reduction, strategic - Read more

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