The FDA issues a complete response letter to JNJ's BLA seeking approval for the subcutaneous formulation of Rybrevant in EGFR-mutated non-small cell lung cancer.

Decoding CRL's International Revenue Trends Canada accounted for 12.74% of the company's total revenue during the quarter, translating to $125.35 million. Revenues from this region represented a ...

The FDA has rejected Abeona Therapeutics' gene therapy pz-cel, specifying chemistry, manufacturing and controls (CMC) issues that must be addressed.