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NEWS

LIB Therapeutics Receives the FDA Approval for Lerochol (Lerodalcibep-liga) for Adults with Elevated LDL Cholesterol 

Shots:  The US FDA has approved Lerochol as an LDL-C lowering therapy for adults with hypercholesterolemia, including HeFH; US launch as a PFS is expected in spring 2026, with an autoinjector later in 2026, while EMA approval is anticipated in Jun 2026 alongside additional global regulatory filings   Approval was supported by the global P-III (LIBerate) trial, enrolling over 2,900 CVD patients and without…
December 12, 2025

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NEWS

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…
December 12, 2025

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Meitheal Pharmaceuticals
NEWS

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…
November 5, 2025

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NEWS

Glaukos Receives FDA Approval for Epioxa

Shots: Glaukos reported the US FDA approval of Epioxa HD/Epioxa, an incision-free, topical drug therapy for keratoconus, offering a non-surgical alternative to traditional corneal cross-linking The approval was based on two P-III pivotal studies (>400 pts) that met its pre-specified 1EPs strong efficacy and safety; Epioxa uses a UV-activated, oxygen-enriched formulation that preserves the corneal…
October 22, 2025

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VIEWPOINTS

Breaking New Ground in Oncology: Leonard Mazur from Citius Pharmaceuticals in Conversation with PharmaShots 

Shots:   Citius Pharmaceuticals celebrates its first-ever FDA approval with Lymphir, a novel therapy for relapsed or refractory cutaneous T-cell lymphoma     In an exclusive conversation, Leonard Mazur, Co-Founder and CEO at Citius Pharmaceuticals, shares insights on Lymphir’s launch strategy and its potential impact on the oncology landscape    Leonard also highlights Mino-Lok, Citius’ innovative…
October 6, 2025

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Viewpoints_Chris Gasink
VIEWPOINTS

Unlocking Approval: Chris Gasink from Johnson & Johnson in an Enlightening Conversation with PharmaShots

Shots: Johnson & Johnson’s (J&J) Tremfya recently received its third approval from the US FDA, supported by the pivotal QUASAR study, which demonstrated significant remission after one year of treatment in adults with moderately to severely active ulcerative colitis Tremfya is a dual-binding monoclonal antibody targeting interleukin 23 (IL-23), a cytokine responsible for inflammation At…
February 3, 2025

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Key Biosimilars Events of October 2024
INSIGHTS+

Key Biosimilars Events of October 2024

Shots:       Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency        Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients        The major highlights were the US FDA’s approval of Dong-A ST’s Imuldosa…
November 5, 2024

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VIEWPOINTS_Marisa Cruz_2023
VIEWPOINTS

Marisa Cruz, in an insightful conversation with PharmaShots, discusses the Empatica Health Monitoring Platform (EHMP)

Shots:  Marisa Cruz, MD, and Chief Medical Officer at Empatica, exchanged thoughts with PharmaShots on the revolutionary Empatica Health Monitoring Platform (EHMP)   Approved by the FDA in Nov’2022, EHMP leverages a cloud-based online portal to collect continuous and seamless physiological data from home and clinical setting   While conversing in great depth about Empatica’s EmbracePlus smartwatch,…
November 2, 2023

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