All articles by Manish Kumar
Manish Kumar
Amneal announces Mesalamine launch, FDA approval for Lenalidomide
Lenalidomide, available in strengths ranging from 2.5mg to 25mg, is a thalidomide analogue used to treat various blood cancers, including multiple myeloma and transfusion-dependent anaemia
X4 Pharmaceuticals and Taiba Rare sign distribution deal for Xolremdi
Taiba Rare will lead Xolremdi distribution and marketing, collaborating with X4 on strategies across Saudi Arabia, the UAE, Qatar, Oman, Kuwait, Bahrain, and Egypt
Cumberland’s Vibativ receives NMPA approval for distribution in China
Vibativ is an injectable antibiotic for hospital-acquired pneumonia, ventilator-associated pneumonia, and complicated skin infections, including MRSA
FDA accepts BLA for Alvotech’s Eylea biosimilar AVT06 review
Alvotech is developing AVT06 and AVT29, two investigational biosimilars for Eylea, targeting the 2 mg and 8 mg HD doses, respectively
KYORIN and Cyrano Therapeutics partner to advance CYR-064
Agreement Provides Cyrano Therapeutics with Upfront and Milestone Payments, Plus Royalties from Commercialization of CYR-064 in Japan
Rznomics gains FDA fast track status for cancer drug candidate RZ-001 in HCC
RZ-001, currently in Phase 1b/2a cancer trials, has received its second fast track designation from the FDA, with the first granted for glioblastoma treatment
Innate Pharma’s lacutamab gets FDA breakthrough status for Sézary syndrome
The designation was based on positive Phase 1 and 2 TELLOMAK results, in which the drug showed promising efficacy and safety in patients with Sézary Syndrome
Fosun Pharma deeply embraces AI, self-developed PharmAID platform boosts efficient innovation
Fosun Pharma is accelerating the deeper application of AI technology in marketing, customer service, and smart office solutions, using AI to improve quality and efficiency while promoting enhanced corporate management effectiveness
FDA approves GSK’s Penmenvy vaccine for meningococcal disease in adolescents and young adults
The vaccine combines GSK’s Bexsero and Menveo components, targeting MenB and MenACWY, to offer broader protection in fewer doses
Samsung Bioepis secures FDA approval for Denosumab biosimilars Ospomyv and XBRYK
The company’s denosumab biosimilars, referencing Amgen’s Prolia and Xgeva, have received FDA approval with a provisional determination for interchangeability