The U.S. FDA on July 15 cleared Biocon Biologics Ltd.’s Kirsty (insulin aspart-xjhz) as the first and only interchangeable biosimilar product referencing Novo Nordisk A/S’ Novolog (insulin aspart), a ...

The U.S. FDA on July 15 cleared Biocon Biologics Ltd.’s Kirsty (insulin aspart-xjhz) as the first and only interchangeable biosimilar product referencing Novo Nordisk A/S’ Novolog (insulin aspart), a ...

Livzon Mabpharm Inc.’s anti-IL-17A/F monoclonal antibody, LZM-012, met the primary endpoint in a phase III trial in moderate to severe plaque psoriasis. Conducted at Fudan University’s Huashan ...

In an about-face, Sarepta Therapeutics Inc. said it would “voluntarily and temporarily” pause all shipments of Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec) in the U ...

Big pharma is increasingly shopping in China to fill its pipelines as it faces looming patent cliffs on major blockbusters coupled with growing pricing pressures on drugs. China’s out-licensing deals ...

Immune evasion continues to limit the effectiveness of cancer immunotherapies. Among emerging regulatory molecules, transfer RNA-derived small RNAs (tsRNAs of 13-48 nucleotides), generated through ...

Cancer cells often use epigenetic changes to resist treatment, a major factor particularly in late-stage deaths from ovarian cancer. One potential epigenetic marker, DNA secondary structures known as ...

Cyclin-dependent kinase 9 (CDK9) plays a critical role in regulating transcriptional elongation and is essential for the expression of short-lived oncogenic and antiapoptotic mRNAs. Targeting CDK9 has ...

The U.S. FDA approved 22 drugs in June, tying with March for the highest number of approvals and a jump from 15 approvals in May. The FDA approved 107 drugs in the first half (H1) of 2025, making it ...

In a 10-1 vote, the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee said Otsuka Pharmaceutical Co. Ltd.’s studies of its combination post-traumatic stress disorder (PTSD) treatment did not ...

Thwarted in her ambition to become a brewmaster, Kiran Mazumdar-Shaw channeled her frustrations into building a knockoff drug powerhouse and has become one of the world’s most successful female ...

Sarepta Therapeutics Inc. made known a third gene therapy death, this time with SRP-9004 for limb-girdle muscular dystrophy. The patient was a late-stage, non-ambulatory 51-year-old man participating ...