Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced that the U.S. Food and Drug Administration (FDA) has approved NGENLA (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone.

This afternoon at 2 pm CET (8 am EDT), Bayer AG will host its Pharmaceuticals R&D Event 2023 for Investors. The company will present a deep dive on the innovation strategy in its four therapeutic core areas Oncology, Cardiovascular Diseases, Neurology & Rare Diseases and Immunology. The presentations will also include status updates on Bayer Pharmaceuticals' key assets in clinical and preclinical development as well as on its platform companies Asklepios BioPharmaceutical (AskBio), BlueRock Therapeutics (BlueRock) and Vividion Therapeutics (Vividion).

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.