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Innovation peaked in December 2025, as the FDA delivered a wave of approvals spanning cardiometabolic disease, infectious disease, respiratory immunology, rare hematologic disorders, and acute cardiovascular and neurologic conditions highlighting both scientific breadth and clinical precisionÂ
Seven notable therapies crossed the regulatory finish line, including LIB Therapeutics’ Lerochol for LDL lowering, Innoviva’s Nuzolvence for gonorrhea, GSK’s Exdensur for asthma with eosinophilic phenotype, Cytokinetics’ Myqorzo…
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The US FDA has approved Nuzolvence for the treatment of uncomplicated urogenital gonorrhea in pts (age ≥12yrs.; Wt.≥35 kg), with US commercialization planned for the H2’26Â
Approval was based on a pivotal P-III multinational trial (n=930) evaluating a single 3g oral dose of Nuzolvence vs ceftriaxone (500 mg IM) + azithromycin (1 g oral) for uncomplicated urogenital gonorrhea, which demonstrated non-inferiority, comparable tolerability…
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Meitheal Pharmaceuticals received the US FDA approval for Contepo (fosfomycin) for injection to treat complicated urinary tract infections (cUTI), including acute pyelonephritis in adults caused by E. coli and K. pneumoniae
The approval was supported by the P-II/III ZEUS (ZTI-01) study that assessed the safety and efficacy of the treatment on hospitalized pts and…
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Basilea Pharmaceutica entered into an exclusive license deal with Venatorx Pharmaceuticals to acquire global rights to ceftibuten-ledaborbactam etzadroxil, a P-III oral beta-lactam/beta-lactamase inhibitor (BL/BLI) combination for complicated urinary tract infections (cUTI), incl. pyelonephritis
Under the agreement, Venatorx will receive an upfront payment along with potential milestone payments in 2025 and will also be eligible…
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Vaccines play a critical role in combating infectious diseases by stimulating antibody production and establishing immune memory. Biopharma companies around the globe continue to drive innovation in vaccine development, targeting both infectious and preventable diseases
The global vaccine market was valued at $87.75B in 2024 and is projected to reach $151.96B by 2033, reflecting…
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In 2024, EMA approved around 53 drugs in various therapy areas, ranging from cardiology, oncology, hematology, neurology, and dermatology to infectious diseases, vaccines, diagnostic agents, pneumology, nephrology, hepatology, ophthalmology, and endocrinology Â
PharmaShots, in an illuminating report, brings a condensed analysis of the approved drugs with the most explored areas being Oncology, Hematology, Neurology, &…
The CCL17 gene, a key player in the human immune system, has garnered significant attention for its role in disease regulation. This chemokine gene is pivotal in mediating immune responses, acting as a messenger that guides immune cells to sites of inflammation. Understanding its function and regulation is essential for unraveling the complexities of immune-related…
Donating sperm is a significant decision that assists numerous individuals and couples in fulfilling their wish to have children. Nonetheless, research on sperm banks reveals a crucial problem: insufficient donors from diverse backgrounds, posing difficulties for recipients seeking compatible matches from varied backgrounds. If you're considering becoming a donor, adequately preparing for your first visit can make…
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Nathan McCutcheon, President, and Chief Executive Officer of Shionogi, shares the highlights of the recent acquisition of Qpex Biopharma by Shionogi Â
Nathan believes that Qpex’s specialized expertise and extensive experience in chemistry and molecular design are sure to strengthen and be useful for the combined antibiotic pipeline Â
The acquisition provides Shionogi exclusive development, manufacturing,…
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Monoclonal antibodies are transforming therapeutics through their highly efficient targeting mechanisms. There is a wide range of uses for monoclonal antibodies, including diagnosis, therapy, and research
In 2021, the monoclonal antibody therapy market size was valued at $178.5B and is envisioned to reach $451.89B by 2028, displaying a CAGR of 14.1%. Humira was the…

