News FDA clears Orca's cell therapy Tregzi for GvHD Orca becomes a commercial-stage biotech with the approval of Tregzi, a cell therapy to prevent a serious complication of stem cell transplants.
News Unicycive hits another hurdle with hyperphosphataemia drug Unicycive Therapeutics' hopes of getting FDA approval of its drug for hyperphosphataemia in dialysis patients have been knocked back again.
News Zymeworks cuts deal to buy Theravance for $929m in cash Zymeworks has reached a deal to buy Theravance, claiming rights to COPD therapy Yupelri, sold by Viatris, which made $267m last year.
News FDA clears Viridian's Tepezza rival for thyroid eye disease Viridian has fired a shot across Amgen's bows with the FDA approval of Tepezza rival Lumvoa in thyroid eye disease, a $2bn market.
News EMA advisors say CSL's Tavneos should be pulled from sale Pressure is building on Amgen to withdraw rare disease therapy Tavneos, after the CHMP recommended its marketing authorisation by revoked in the EU.
News Sanofi faces EU investigation over flu shot marketing The European Commission is investigating a marketing campaign run by Sanofi for a flu vaccine, to see if it disparaged its only rival in the market.
News Enhertu OK ends 10-year EU gap in frontline breast cancer Enhertu plus Perjeta has become the first new frontline therapy approved for advanced HER2-positive breast cancer in the EU for over a decade.
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