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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...