On June 16, the CDE official website showed that the New Drug Application (NDA) for Mezigdomide capsules, developed by BMS, has been accepted. The drug is indicated for use in combination with carfilzomib and dexamethasone for the treatment of adult…
On June 15, the NMPA official website showed that the Category 5.1 drug Lidocaine and Prilocaine Aerosol Spray, jointly filed by Plethora Solutions and Fosun Pharma, has been approved for marketing in China for the treatment of primary premature ejaculation…
On June 15, the NMPA official website showed that Zelgen Pharmaceuticals’ Category 1 new drug Jicatinib has been approved for a new indication for the treatment of severe alopecia areata (Acceptance No.: CXHS2500046). Alopecia areata is a common inflammatory non-scarring…
On June 15, the NMPA official website announced that Hengrui Medicine’s self-developed CDK4/6 inhibitor, Dalpiciclib Hydrochloride Tablets, has been approved for a new indication. The new indication is for the adjuvant treatment of hormone receptor (HR)-positive, human epidermal growth factor…
On June 15, the NMPA official website showed that Bristol Myers Squibb’s TYK2 inhibitor Deucravacitinib has been approved for a new indication in China for the treatment of psoriatic arthritis . Deucravacitinib is a tyrosine kinase 2 (TYK2) inhibitor that…
On June 15, Daiichi Sankyo announced that its FLT3 inhibitor, Quizartinib Hydrochloride Tablets, has been approved for marketing in China. The drug is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have been…
Recently, Merck announced that the U.S. FDA has approved the combination regimen of its HIF-2α inhibitor Welireg (belzutifan) and PD-1 inhibitor Keytruda (pembrolizumab) as adjuvant therapy for adult patients with renal cell carcinoma (ccRCC) containing a clear cell component who…
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…
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…