The FDA has advanced multiple significant approvals impacting biotech therapeutics and diagnostics. Merck’s Keytruda received clearance for a rapid subcutaneous injection formulation, enabling administration in about a minute, improving patient convenience over traditional infusions. Stealth BioTherapeutics obtained accelerated approval for its Barth syndrome drug, elamipretide, concluding a protracted regulatory process. OGT gained authorization for its FISH assay serving as a companion diagnostic for Syndax’s acute leukemia therapy. Meanwhile, Sanofi faces a delayed decision on the multiple sclerosis drug tolebrutinib, reflecting regulatory caution. These developments underscore evolving biotech therapy pipelines and diagnostic tools entering markets.