Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for fidanacogene elaparvovec for the treatment of adults with hemophilia B. In parallel, the European marketing authorization application (MAA) for fidanacogene elaparvovec has also been accepted and is under review by the European Medicines Agency (EMA).

Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved LITFULO™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. The approved recommended dose for LITFULO is 50 mg. It is the first and only treatment approved by the FDA for adolescents (12+) with severe alopecia areata.

Pfizer (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved TALZENNA (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI (enzalutamide), for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

AstraZeneca, a leader in cardiorenal diseases, presented new real-world evidence (RWE) data at the European Renal Association (ERA) 2023 Congress in Milan, Italy, demonstrating the staggeringly low rate of diagnosis in chronic kidney disease (CKD). These data show that an urgent need exists for improved screening which can lead to earlier diagnosis.

Results from the REVEAL-CKD multinational study showed that the prevalence of undiagnosed Stage 3 (moderate) CKD was 85% to 97% across Spain, Australia, Canada and Brazil.

Bayer and Cedilla Therapeutics, a biotechnology company bringing a new dimension to precision oncology, announced an exclusive license agreement to develop and commercialize Cedilla Therapeutics' CyclinE1/CDK2 complex inhibitors which selectively address oncogenic drivers.

Overexpression or genetic activation of Cyclin Dependent Kinase 2 (CDK2) binding partner cyclin E is a key oncogenic process in several cancers.

AstraZeneca has entered into an exciting collaboration, exclusive option and license agreement with Quell Therapeutics to develop multiple engineered T-regulator (Treg) cell therapies that have the potential to be curative in Type 1 Diabetes (T1D) and Inflammatory Bowel Disease (IBD) indications.

Under the terms of the agreement, Quell's proprietary toolbox of Treg cell engineering modules, including its innovative Foxp3 Phenotype Lock will be leveraged to develop autologous multi-modular Treg cell therapy candidates for major autoimmune disease indications.

Bayer AG is joining forces with Acuitas Therapeutics, Inc., a biotechnology company specializing in the development of lipid nanoparticle (LNP) delivery systems for molecular therapeutics. Acuitas' LNP technology will support Bayer's in vivo gene editing and protein replacement programs by specifically delivering RNA payloads to the desired target organ, the liver.