J-Pharma Co. Ltd. is progressing the most clinically advanced L-type amino acid transport 1 (LAT1) inhibitor, nanvuranlat (JPH‑203), in a global phase III Beacon-BTC study of biliary tract cancer following U.S. FDA alignment.

Four years after the U.S. FDA issued a complete response letter for Spero Therapeutics Inc.’s oral antibiotic, tebipenem pivoxil hydrobromide, to treat complicated urinary tract infections (cUTI), including pyelonephritis, the agency approved the drug based on phase III data showing noninferiority to intravenous imipenem-cilastatin.

Three years on from the rebuff of a U.S. FDA complete response letter, F2G Ltd. now has the data needed to resubmit the NDA for the first novel antifungal drug in more than two decades. Along with partner Shionogi & Co. Ltd., F2G has released positive phase III results for orally administered olorofim, showing noninferiority against I.V.-administered Ambisome (amphotericin B, Gilead Sciences Inc.) in patients with refractory aspergillosis infections, or who were unsuitable for mainstay azole therapy.

The U.S. FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously in favor of Moderna Inc.’s trivalent mRNA flu vaccine, mRNA-1010, which the company wants to brand as Mflusiva. On the question of whether the benefits of the product outweigh the risks in people ages 50 to 64, balloting was 9-0, and on whether the same is true in those 65 and older, the tally was again 9-0.

Shares of Abcellera Biologics Inc. got a modest boost on news of a preclinical research collaboration with Jazz Pharmaceuticals plc aimed at developing next-generation T-cell engaging multispecific antibodies targeting gastrointestinal cancers and other solid tumors.

Spyre Therapeutics Inc.’s striking “two for two” data on ulcerative colitis (UC) candidates, SPY-001 and SPY-002, drew applause from multiple analysts, putting eyes on the Boston biotech’s upcoming top-line data of anti-IL-23 antibody SPY-003 – the third biologic module in a six-strong inflammatory bowel disease (IBD) lineup.

In a little more than a month, 17 big biopharma companies will be subject to U.S. President Donald Trump’s long-promised section 232 global biopharma sector tariff. But instead of paying the 100% duty on imported patented drugs and their key ingredients, most of those companies, if not all, will pay much reduced rates or no tariff at all, based on where the imports are coming from, what type of drug is being imported, and whether the companies have signed onshoring and most-favored-nation pricing agreements with the administration.

Another day, another about-face by the U.S. FDA on Uniqure NV’s Huntington’s disease gene therapy. But this latest shift brings good news for the company’s AMT-130, for which the FDA says three-year analysis data from the phase I/II study will be acceptable for an accelerated BLA filing, now expected to be submitted in the third quarter.