News Bayer moves Hyrnuo into frontline lung cancer treatment Bayer chases after Boehringer with an FDA approval for oral HER2 inhibitor Hyrnuo in previously untreated HER2+ lung cancer.
News NICE says no to Gilead's lenacapavir for HIV PrEP NICE's decision not to recommend NHS funding of Gilead's twice-yearly injectable for prevention of HIV has drawn fierce criticism from charities.
News Amgen's Imdelltra scores again in small cell lung cancer Amgen's Imdelltra and AstraZeneca's Imfinzi have improved survival compared to Imfinzi alone as first-line maintenance treatment for ES-SCLC.
News BMS eyes role for new CAR-T in post-BCMA multiple myeloma BMS' arlo-cel has shown activity in a trial that could underpin filings in multiple myeloma settings where the four main drug classes have failed.
News FDA starts review of AZ's COPD blockbuster hope The FDA has started a priority review of AstraZeneca's first-in-class IL-33 inhibitor tozorakimab for COPD, setting up a decision in Q1 of 2027.
News FDA makes acting CDER, CBER chiefs permanent Michael Davis becomes the permanent head of CDER, while Karim Mikhail is confirmed as permanent CBER director and the FDA names its first AI leader.
Oncology Getting predictive technologies to patients, with Concr Dr Irina Babina, CEO of oncology R&D platform Concr, discusses how current regulatory frameworks were built for static diagnostics.
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