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The US FDA New Drug Approvals in December 2025 

Shots:  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 precision  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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Innoviva Specialty Therapeutics Receives the FDA Approval for Nuzolvence (Zoliflodacin) for Uncomplicated Urogenital Gonorrhea 

Shots:  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 H2’26  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

Meitheal Pharmaceuticals Receives the US FDA Approval for Contepo (Fosfomycin) Injection to Treat cUTI in Adults

Shots: 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 Enters Into a Licensing Deal with Venatorx Pharmaceuticals

Shots: 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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Top 20 Vaccines of 2025

Top 20 Vaccines of 2025 

Shots:  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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A Complete Account of EMA Approvals in 2024

A Complete Account of EMA Approvals in 2024

Shots:   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   PharmaShots, in an illuminating report, brings a condensed analysis of the approved drugs with the most explored areas being Oncology, Hematology, Neurology, &…

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Preparing for Your First Sperm Donation Appointment

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 shares highlights of Qpex Biopharma’s acquisition by Shionogi

Shots:  Nathan McCutcheon, President, and Chief Executive Officer of Shionogi, shares the highlights of the recent acquisition of Qpex Biopharma by Shionogi   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   The acquisition provides Shionogi exclusive development, manufacturing,…

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