On June 5, the NMPA official website announced that the Category 1.1 innovative traditional Chinese medicine (TCM) drug Zaoren Ningxin Dropping Pills (formerly known as Anshen Dropping Pills) has been approved for marketing, providing a new treatment option for patients…
Recently (June 4), Qilu Pharmaceutical’s Category 1 new drug QLS2311 Injection received its first clinical trial approval. According to available information, this product represents Qilu’s first Category 1 new drug in the antithrombotic field, with the indication targeting acute ischemic…
On June 11, the U.S. clinical trials registry website showed that Biohaven has initiated the first Phase III clinical trial (BHV1400-301) for BHV-1400, its next-generation degrader. The study is a randomized, multicenter, double-blind, placebo-controlled clinical trial (n=420) designed to evaluate…
FDA Approves Zaynich for the Treatment of Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis, Caused by Specific Susceptible Microorganisms in Adult Patients Dosage Form: Lyophilized powder for injection: 3 g (cefepime and zidebactam) as a sterile powder in a single-dose vial…
On June 1, Shionogi announced that its oral antiviral drug XOCOVA® (ensitrelvir) has received U.S. FDA approval for post-exposure prophylaxis (PEP) of COVID-19 in adolescents aged 12 years and older and in adult patients. This approval came more than two…
Johnson & Johnson (J&J) Presents Full Data from Phase 2b JASMINE Study of Nipocalimab in Systemic Lupus Erythematosus (SLE) at EULAR 2026 I. Introduction: The SLE Treatment Landscape is Being Reshaped Systemic lupus erythematosus (SLE) is a chronic autoimmune disease…
On June 11 local time, Roche announced that the U.S. FDA has accepted the company’s supplemental Biologics License Application (sBLA) seeking approval for atezolizumab (Tecentriq®) and atezolizumab and hyaluronidase injection (Tecentriq Hybreza®) in combination with chemotherapy as adjuvant treatment for…
On June 12 local time, Sanofi announced that the U.S. FDA has granted accelerated approval for Tzield (teplizumab-mzwv) to delay the decline in endogenous insulin secretion in children aged 8 to 17 years recently diagnosed with Stage 3 type 1…
On June 12 local time, AstraZeneca announced that its AKT inhibitor Truqap (capivasertib) has been approved for a new indication in the United States, in combination with abiraterone and prednisone, for the treatment of adult patients with PTEN-deficient metastatic hormone-naïve…
On June 11, the Clinicaltrials.gov official website showed that Biokin Pharmaceutical has registered a Phase III clinical trial, PANKU-Lung08, to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib versus osimertinib (a third-generation EGFR-TKI) monotherapy in patients with EGFR-mutant non-small…