ANDA approval for 100 mg and 150 mg capsules targeting idiopathic pulmonary fibrosis opens access to a $3.76 billion market in USA
Key FDA decisions and pivotal late-stage obesity and breast cancer data could reshape competitive positioning
The trial, dubbed MALBEC, marks the first in a broader late-phase development push for MK-8748, with a second NVAMD study expected to begin later this year
The study targets patients with refractory, unresectable microsatellite-stable (MSS)/mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC)
Ac-225, an alpha-emitting radionuclide, can be paired with molecules designed to selectively target cancer cells.
This marks a meaningful step in the company's continued expansion in the region
The approval is backed by results from Lilly’s ATTAIN clinical trial program, which showed significant weight loss among participants
The price revision, effective April 3, 2026, brings the innovator molecule within the reach of a significantly larger patient base across the country
Lonza will take on technology transfer, process optimization, and cGMP manufacturing, leveraging its global network and expertise in highly potent compounds
Broadens downstream purification portfolio with next-generation Protein A chromatography for scalable manufacturing
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