FDA advisory panel narrowly withholds support for AstraZeneca’s combo in breast cancer
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3 to 6 against recommending camizestrant in combination with a CDK4/6 inhibitor
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3 to 6 against recommending camizestrant in combination with a CDK4/6 inhibitor
The product is manufactured at AKUMS’ state-of-the-art injectable facility in Kotdwar, Uttarakhand
Profitability came under strain. Gross profit fell to EUR 246m, with margins narrowing to 23.7% as negative product mix—particularly in Asia Pacific—weighed on performance
Move amid evidence of widespread reporting gaps
TG4050 harnesses Transgene’s myvac platform and NEC’s AI-powered neoantigen prediction technology to tailor vaccines to each patient’s tumor
Key FDA decisions and pivotal late-stage obesity and breast cancer data could reshape competitive positioning
The FDA approval makes PD-L1 IHC 22C3 pharmDx the only companion diagnostic approved to detect tumors expressing PD-L1 in esophageal or GEJ carcinoma patients for KEYTRUDA treatmen
The decision is based on the phase 3 DESTINY-Breast11 trial
Giredestrant shows promise despite missing primary goal
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