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Moderna's mCombriax combination flu and COVID-19 vaccine wins European drug regulators' positive recommendation for ages 50+
Vaccine, infectious disease, mRNA vaccine, COVID-19, influenza, combination therapy - Read more

Henlius' HLX11 (pertuzumab) biosimilar receives CHMP approval recommendation for HER2-positive breast cancer treatment
Antibody, cancer, biosimilar, breast cancer, HER2 target, pertuzumab - Read more

Ascendis Pharma's Yuviwel wins FDA accelerated approval for achondroplasia in children with open growth plates
Protein therapy, rare disease, growth hormone therapy, achondroplasia, pediatric population - Read more

FDA approves Novo Nordisk's weekly Sogroya for three additional pediatric growth disorders
Protein therapy, endocrine disorders, growth hormone, pediatric population, idiopathic short stature - Read more

Innovent Biologics wins China approval for Jaypirca (pirtobrutinib) targeting chronic lymphocytic leukemia following Ph3 trial
Small molecule, cancer, BTK inhibitor, chronic lymphocytic leukemia, relapsed or refractory - Read more

Hua Medicine's MYHOMSIS (dorzagliatin) glucokinase activator wins Hong Kong approval for type 2 diabetes treatment
Small molecule, metabolic, glucokinase activator, type 2 diabetes, first-in-class - Read more

Chiesi Global Rare Diseases receives FDA approval for JUXTAPID (lomitapide) capsules in pediatric homozygous familial hypercholesterolemia
Small molecule, metabolic, homozygous familial hypercholesterolemia, pediatric, MTP inhibitor - Read more

Earendil Labs, WuXi XDC partner on next-gen ADC linker technology, $885M total deal
Licensing deal, oncology, antibody, AI/ML, milestone payments - Read more

Quotient Sciences, Ipsen extend supply pact for rare disease drug Sohonos with facility investments
Manufacturing agreement, rare disease, small molecule, highly potent compounds - Read more

Sanofi, Sino Biopharmaceutical license JAK/ROCK inhibitor rovadicitinib globally, $135M upfront, $1.53B total
Licensing deal, rare disease, small molecule, milestone payments, hematology, immunology - Read more

Congruence Therapeutics, Ono Pharmaceutical expand multi-target research partnership adding neurology and immunology programs
Research collaboration, small molecule, neurological, immunology, milestone payments - Read more

Cystic Fibrosis Foundation, Antiverse partner on AI-powered antibody discovery targeting CFTR protein
Research collaboration, rare disease, AI/ML, antibody - Read more

Merck & Co., Tempus strike multi-year AI oncology data deal, financial terms undisclosed
Research collaboration, oncology, AI/ML, drug discovery - Read more

Insilico Medicine, Liquid AI partner on lightweight scientific foundation models for drug discovery
Research collaboration, AI/ML, drug discovery, small molecule - Read more

UCB, Antengene partner on B cell-depleting bispecific antibody ATG-201, $80M upfront, $1.1B milestones
Licensing deal, autoimmune, bispecific antibody, milestone payments - Read more

Grünenthal acquires Kyowa Kirin's 49% stake in joint venture, taking full ownership of €170M ($199.9M) established medicines portfolio
Small molecule, pain management, strategic, major transaction - Read more

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Bayer reports encouraging Ph1 results for 225Ac-PSMA-Trillium targeting metastatic castration-resistant prostate cancer
Targeted radionuclide therapy, cancer, prostate-specific membrane antigen, metastatic castration-resistant prostate cancer, actinium-225 - Read more

Galderma's Nemluvio (nemolizumab) shows sustained efficacy up to three years in prurigo nodularis extension study
Antibody, autoimmune, monoclonal antibody, prurigo nodularis, IL-31 receptor antagonist - Read more

BioNTech and DualityBio advance BNT324 (DB-1311) B7-H3 ADC to Ph3 for metastatic castration-resistant prostate cancer
Antibody-drug conjugate, cancer, metastatic castration-resistant prostate cancer, B7-H3 target - Read more

Pfizer, Astellas and Merck & Co.'s Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin) combo cuts bladder cancer recurrence 47% in Ph3
Antibody, cancer, antibody-drug conjugate, bladder cancer, combination therapy, PD-1 inhibitor - Read more

Lynk Pharmaceuticals' zemprocitinib JAK1 inhibitor hits Ph3 endpoints in moderate to severe atopic dermatitis
Small molecule, autoimmune, JAK inhibitor, atopic dermatitis, JAK1 selectivity - Read more

United Therapeutics prepares FDA filing for ralinepag following Ph3 success in pulmonary arterial hypertension treatment
Small molecule, cardiovascular, prostacyclin agonist, pulmonary arterial hypertension, once-daily dosing - Read more

Roche's fenebrutinib (BTK inhibitor) hits Ph3 goals in relapsing multiple sclerosis despite safety concerns
Small molecule, autoimmune, BTK inhibitor, multiple sclerosis, liver toxicity - Read more

Bioxytran reports positive Ph1b/2a results for ProLectin-M targeting galectin in mild to moderate coronavirus disease
Small molecule, infectious disease, antiviral, COVID-19, galectin-targeting, oral therapy - Read more

Rhythm Pharmaceuticals reports positive Ph3 data for setmelanotide (setmelanotide) targeting acquired hypothalamic obesity
Small molecule, metabolic, melanocortin receptor agonist, hypothalamic obesity, hunger reduction - Read more

Blueprint Medicines presents four-year data showing sustained benefit of AYVAKIT (avapritinib) in indolent systemic mastocytosis
Small molecule, hematological disorders, kinase inhibitor, systemic mastocytosis, KIT inhibitor - Read more

LongBio's LP-003 shows superior efficacy versus Xolair in Ph2 chronic spontaneous urticaria trial
Antibody, autoimmune, monoclonal antibody, chronic spontaneous urticaria, anti-IgE therapy, omalizumab comparison - Read more

AbbVie's Skyrizi (risankizumab) meets Ph3 endpoints for Crohn's disease subcutaneous induction treatment
Antibody, autoimmune, monoclonal antibody, Crohn's disease, IL-23 inhibitor, subcutaneous - Read more

Pharvaris presents deucrictibant (bradykinin B2 receptor antagonist) Ph3 data for hereditary angioedema treatment at AAAAI
Small molecule, autoimmune, bradykinin B2 receptor antagonist, hereditary angioedema, on-demand treatment, prophylaxis - Read more

Quell Therapeutics shows QEL-001 CAR-Treg safety and efficacy in Ph1/2 liver transplantation trial
Cell therapy, autoimmune, CAR-T, liver transplant, HLA-A2 target, immunosuppression weaning - Read more

COUR Pharma reports positive one-year Ph2a results for CNP-104 in primary biliary cholangitis
Immune tolerance therapy, autoimmune, antigen-specific immunotherapy, primary biliary cholangitis, liver fibrosis - Read more

Atrium Therapeutics spins out of Novartis-acquired Avidity with $270M to develop RNA medicines for rare heart diseases
RNA therapeutics, rare disease, strategic, spinout - Read more

Prolium Bioscience debuts with $50M Series A funding to advance China-licensed autoimmune TCE PR-203
T-cell engager, autoimmune, strategic, major transaction - Read more

Persevere Therapeutics launches with Phase 1b/2a oncology asset misetionamide and closes first seed financing tranche
Small molecule, oncology, strategic, seed financing - Read more

UCB's Bimzelx crosses blockbuster threshold with €2.22B ($2.62B) sales driven by hidradenitis suppurativa momentum
Monoclonal antibody, autoimmune, strategic, blockbuster sales, competitive - Read more

Alveus Therapeutics raises $37M Series A extension for obesity drug development
Clinical-stage, metabolic disease, protein therapeutics, GLP-1 - Read more

QL Biopharm raises $72M Series C, developing long-acting GLP-1 obesity drug
Obesity, GLP-1 receptor agonist, clinical-stage, metabolic disease - Read more [Paywall]

Zymeworks raises $250M royalty-backed note financing for share repurchases, acquisitions
Oncology, antibody, HER2-targeted therapy, clinical-stage - Read more

Poplar Therapeutics raises $45M Series A extension for anti-IgE therapy development
Clinical-stage, autoimmune, anti-IgE therapy, food allergy - Read more

Precision BioSciences raises $7.5M funding, clinical stage gene editing platform development
Gene therapy, clinical-stage, platform technology, genetic diseases - Read more

MAIA Biotechnology raises $30M public offering, targeted immunotherapies for cancer
Cancer, targeted immunotherapies, clinical-stage - Read more

Novo Nordisk commits $506M to upgrade Irish facility for oral Wegovy production ahead of European approval
Oral GLP-1, metabolic disease, major transaction, operational - Read more

Genevant Sciences and Arbutus Biopharma reach $2.25B global patent settlement with Moderna over LNP technology
Lipid nanoparticle, infectious disease, major transaction, strategic - Read more

Candid Therapeutics to go public through reverse merger with RallyBio, raising $505M for bispecific antibodies
Bispecific antibody, autoimmune, strategic, major transaction - Read more

Gyre Therapeutics to acquire Cullgen for $300M to gain targeted protein degradation platform
Targeted protein degradation, oncology, strategic, major transaction - Read more

Swiss Rockets acquires Complete Genomics to expand precision medicine capabilities with advanced DNA sequencing technology
Radioligand therapy, oncology, strategic, major transaction - Read more

Esperion acquires Corstasis Therapeutics for $75M upfront plus milestones, adding nasal spray diuretic Enbumyst
Small molecule, cardiovascular, strategic, major transaction - Read more

Fagron completes acquisition of Vepakum packaging specialist in Latin America following Brazilian regulatory approval
Pharmaceutical compounding, strategic, major transaction, operational - Read more

Eli Lilly, Nvidia unveil LillyPod supercomputer and $1B AI co-innovation lab partnership
Technology partnership, AI/ML, drug discovery, co-innovation, equity investment - Read more

Quest Diagnostics launches Google-powered AI chatbot to help patients understand lab results
Digital health, diagnostic technology, strategic, operational - Read more

Merck & Co.'s Welireg receives FDA priority review for early-stage RCC with positive trial data
Small molecule, oncology, strategic, regulatory - Read more

FDA fully lifts clinical hold on Intellia Therapeutics' CRISPR gene therapy nex-z trials
CRISPR gene therapy, rare disease, regulatory, strategic - Read more

FDA announces bonus payment pilot program for regulatory staff completing drug reviews ahead of schedule
Regulatory, operational, strategic, financial - Read more

Biohaven reduces R&D cutbacks scope while accelerating protein degrader trials for Graves' disease, IgA nephropathy
Protein degrader, neurological, cost reduction, operational - Read more

Acadia Pharmaceuticals seeks CHMP re-examination of Daybue (trofinetide) after EU rejection for Rett syndrome treatment
Small molecule, neurological, Rett syndrome, rare disease, trofinetide - Read more

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Considering sponsoring TLDR Biotech to get in-front of an engaged audience of biotech & pharma-focused professionals.

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FDA rejects REGENXBIO's RGX-121 gene therapy for Hunter syndrome citing inadequate controls and surrogate endpoints
Gene therapy, metabolic, Hunter syndrome, adeno-associated virus, surrogate endpoints - Read more

FDA rejects uniQure's Huntington's gene therapy AMT-130 filing, demands new sham-controlled trial, shares drop 35%
Gene therapy, neurological, regulatory, strategic - Read more

Boehringer Ingelheim, OSE Immunotherapeutics end MASH partnership after phase 2 efficacy failure
Partnership termination, oncology, autoimmune, antibody, milestone payments - Read more

Aardvark Therapeutics pauses ARD-101 taste receptor activator Ph3 trial for Prader-Willi syndrome hyperphagia over cardiac safety signals
Small molecule, rare genetic disease, taste receptor activator, Prader-Willi syndrome, hyperphagia, cardiac safety - Read more

Kyowa Kirin discontinues rocatinlimab anti-OX40 antibody atopic dermatitis trials following safety concerns over malignancies
Antibody, autoimmune, monoclonal antibody, atopic dermatitis, OX40 target, safety concerns - Read more

EveryOne Medicines shuts down after FDA's individualized therapy pathway falls short of expectations
Gene therapy, rare disease, regulatory, operational - Read more [Paywall]

Merck & Co. winds down Gardasil production at Durham plant, lays off 150-plus amid worldwide demand decline
Vaccine, infectious disease, operational, cost reduction - Read more

BioAtla axes 70% of workforce, explores strategic options including asset sales and partnerships
Antibody drug conjugate, oncology, strategic, operational, financial - Read more

Theravance Biopharma to cut 50% of workforce after ampreloxetine fails Phase III hypotension study
Small molecule, neurological, cost reduction, operational - Read more

Disc Medicine lays off 20% of workforce after FDA rejects bitopertin for rare blood disease
Small molecule, rare disease, operational, cost reduction - Read more

HHS bans Claude AI tool as Trump seeks full government blacklisting of Anthropic
Artificial intelligence, drug development, operational, regulatory - Read more

FDA issues warning letter to ExThera over unauthorized promotion of Seraph 100 blood filter device
Medical device, oncology, regulatory, operational - Read more

Pfizer CEO Albert Bourla criticizes FDA's Vinay Prasad, claims CBER leadership problems affecting vaccine regulation
Vaccine, infectious disease, regulatory, strategic - Read more

Pierre Fabre Pharmaceuticals requests urgent FDA meeting to discuss Ebvallo cell therapy rejection for post-organ transplant malignancy
Cell therapy, cancer, post-transplant lymphoproliferative disorder, EBV-targeted therapy - Read more

FDA issues warning letters to 30 telehealth firms over misleading compounded GLP-1 drug claims
GLP-1 receptor agonist, metabolic disease, regulatory, operational - Read more

Pfizer withdraws EU filing for PD-1 inhibitor sasanlimab in bladder cancer amid EMA concerns
PD-1 inhibitor, oncology, regulatory, strategic - Read more

FDA investigates Prasad for workplace toxicity allegations at Center for Biologics Evaluation and Research
Cell and gene therapy, regulatory, operational, strategic - Read more

RFK Jr. appoints two new vaccine-skeptical advisors to CDC's Advisory Committee on Immunization Practices panel
Vaccine, infectious disease, regulatory, operational - Read more

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