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Other Voices: Streamline the FDA’s cumbersome regulatory process

Good news strikes from an unlikely source. On Thursday the Food and Drug Administration approved Replimune’s immunotherapy for metastatic melanoma, a day after it green-lighted mFlusiva, Moderna’s mRNA flu vaccine. The shame is that both might have been available sooner but for regulatory delays, which hurt both patients and American innovation. Replimune has been working on its RP1 immunotherapy for a decade but got caught in the FDA cross-hairs at the last stretch. FDA review staff recommended approval after its late-stage trial showed that a third of patients whose disease had ...

Summer of Rage and Races

WASHINGTON -- Somebody stop him. You know who. The conqueror whose voice, face and deeds are inescapable. Donald Trump had never heard of William the Conqueror when he visited England, but he loved the word and the idea for his presidency. He also has Napoleon Bonaparte and Julius Caesar ...

Yankees complete 3-game sweep of Orioles

BALTIMORE (AP) — Gerrit Cole pitched six sharp innings, Luis García Jr. and Spencer Jones homered and the New York Yankees completed a three-game sweep in Baltimore with a 6-1 victory over the Orioles on Thursday night. Cole (7-6) allowed four hits and a walk with eight strikeouts. A ...

McIlroy in 5-way tie at BMW

ST. LOUIS (AP) — Rory McIlroy might not be as far away as he thought four days ago, playing bogey-free at Bellerive for a 6-under 64 that gave him a share of the lead Thursday in the BMW Championship with three other U.S. Open champions and Chris Gotterup. Four days brought a big change for Scottie Scheffler, too. The world's No. 1 player went from an eight-shot victory in the postseason opener to feeling under the weather and having to rally for a 72, his highest opening round since the U.S. Open in June. Scheffler's voice was hoarse when he said he didn't want to stop to talk, ...