Policy
In what may be the most significant regulatory development for biotech in a decade, the FDA announced on February 18, 2026, that it is abandoning its long-standing expectation of two pivotal clinical trials for new drug approvals. Moving forward, the agency will require only one adequate and well-controlled clinical trial
Pharmaceuticals
The FDA's unprecedented rejection of Moderna's mRNA flu vaccine application marks a dramatic departure from traditional regulatory practices and raises profound questions about the future of vaccine innovation in America.
Biotechnology
Nagpur-based ErlySign receives FDA Breakthrough Device Designation for its innovative saliva-based oral cancer detection kit, marking a significant milestone in non-invasive cancer diagnostics.
Pharmaceuticals
Pharming Group announced that the FDA issued a Complete Response Letter for its supplemental application to expand Joenja treatment to children aged 4-11 with APDS, citing concerns about dosing precision and manufacturing quality.
Biotechnology
The FDA's acceptance of Tasly's 3P Characterization of MSCs Assay marks the first FDA-recognized quality control standard for mesenchymal stromal cells, establishing a new benchmark for the cell therapy industry and accelerating the path to consistent, safe, and effective MSC-based therapies.
Pharmaceuticals
The final days of 2025 delivered unwelcome surprises to two pharmaceutical companies as the FDA issued complete response letters rejecting drug applications from both Sanofi and Corcept Therapeutics. These unexpected regulatory setbacks underscore the unpredictable nature of drug approval processes and highlight how even promising therapies with strong clinical data