Unicycive OLC received a second FDA CRL over third-party manufacturing deficiencies. The case shows why CMC risk now drives ...

AlzeCure licensed NeuroRestore ACD856 to QuantumCell in a deal worth over $2.2B. The real story is not proof, but Alzheimer’s ...

Reuters reported that Viridian plans to launch Lumvoa immediately as its first commercial product, and that the company expects to price the drug at parity with the existing approved IGF-1R therapy on ...

FDA gave Sobi a Complete Response Letter for NASP in uncontrolled gout, but the letter did not attack the clinical case. It attacked manufacturing control, CMC readiness and contract manufacturing ...