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VIEWPOINTS

Advancing HES Care with AstraZeneca’s FASENRA: Insights from James Teague & Princess U. Ogbogu

Shots:  Could a targeted biologic therapy help address the longstanding unmet needs in hypereosinophilic syndrome (HES)? AstraZeneca’s FASENRA has now received US approval for HES, introducing a once-monthly treatment option for patients living with this rare and often underdiagnosed eosinophilic disorder  Results from the Phase III NATRON trial showed that FASENRA reduced the risk of first HES flare by 65% vs placebo,…
June 1, 2026

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NEWS

Shionogi Secures US FDA Approval of Xocova for PEP COVID-19 Prevention

Shots:  The US FDA has approved Xocova (ensitrelvir) for post-exposure prophylaxis (PEP) of COVID-19 in adults and adolescents (age≥12 yrs) following exposure to a person with COVID-19  Approval was based on a global P-III (SCORPIO-PEP) trial in 2,387 participants aged ≥12 yrs exposed to a household member with symptomatic COVID-19. The primary analysis included 2,041 SARS-CoV-2-negative participants who received Xocova (n=1,030; 375 mg on…
May 29, 2026

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NEWS

Wockhardt Receives US FDA Approval for Zaynich to Treat cUTI Including Pyelonephritis 

Shots:  The US FDA has approved Zaynich (Cefepime and Zidebactam) for treating adults with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by susceptible Gram-negative bacteria  Approval was based on a P-III (ENHANCE-1) trial in 530 adults with cUTI or acute pyelonephritis across 64 global sites, where Zaynich demonstrated superior clinical and microbiological response rates vs. meropenem (89.0% vs. 68.4%) and was generally well tolerated  Zaynich is an injectable…
May 29, 2026

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NEWS

Haisco Pharmaceutical Secures US FDA Approval of Cypsedo for Adult General Anesthesia Prior to Surgery 

Shots:  The US FDA has approved Cypsedo (Cipepofol) to induce general anesthesia in adults undergoing surgery  Cipepofol (Chinese trade name: Sishuning) is China's first domestically developed Class 1 innovative intravenous anesthetic with global IP rights. It is approved in China for procedural sedation, induction and maintenance of general anesthesia, and ICU sedation during mechanical ventilation  In Dec 2020, Cipepofol, approved…
May 29, 2026

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INSIGHTS+

Key Biosimilars Events of March 2026 

Shots:  Regulatory momentum remained strong, with key biosimilar launches and approvals including Celltrion’s Remsima IV (EU) and Avtozma SC (US), Teva’s FDA-approved Ponlimsi, Japan’s approval of tocilizumab BS MA by Mochida Pharmaceutical and AYUMI Pharmaceutical, and IND clearance for HLX18 by National Medical Products Administration.  Strategic partnerships expanded access, led by Samsung Bioepis–Sandoz collaboration, Formycon’s aflibercept settlement deal with Regeneron Pharmaceuticals and Bayer, and Bio-Thera…
April 7, 2026

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NEWS

Acrotech Biopharma and Otsuka Pharmaceutical Receive the US FDA Approval for Adquey to Treat Mild-to-Mod. Atopic Dermatitis 

Shots:  The US FDA has approved Adquey (difamilast 1%) ointment for treating mild-to-mod. atopic dermatitis in adults and children aged≥ 2 yrs.  Approval was based on multiple pivotal P-III trials, which showed a significantly higher proportion of patients treated with ADQUEY achieving IGA success after 4 wks vs vehicle, with a consistent safety profile  Adquey is a non-steroidal topical PDE-4 inhibitor for BID treatment…
February 12, 2026

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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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