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FDA approves AstraZeneca’s oral SERD camizestrant despite negative advisory-panel vote

The FDA granted accelerated approval on September 4, 2026, to AstraZeneca’s camizestrant, marketed as Etcamah, in combination with a CDK4/6 inhibitor—abemaciclib, palbociclib, or ribociclib. The approval covers adults with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer whose tumors develop an ESR1 mutation while receiving an aromatase inhibitor plus a CDK4/6 inhibitor. The decision followed a 6–3 negative vote by the FDA’s Oncologic Drugs Advisory Committee in April. The committee’s recommendation was nonbinding, allowing the FDA to reach a different conclusion. Advisers questioned the SERENA-6 trial’s design, the absence of mature overall-survival data, quality-of-life evidence, and whether changing therapy based on circulating-tumor-DNA results before radiographic progression provides a clinically meaningful benefit. SERENA-6 reportedly showed a 56% reduction in the risk of disease progression or death versus continuing standard treatmen...

BrainChild Bio raises $116M to advance CAR-T therapy for pediatric brain cancer

AbbVie-backed ADARx files for IPO to fund clinical-stage siRNA pipeline

Roivant’s $14M Bayer Deal Shows Strong Phase 2 Results

Novo Nordisk halts two more IL-6 heart-drug trials for futility

Novartis drops after Avidity-acquired muscle-drug trial miss

Menarini licenses Gan & Lee’s biweekly GLP-1 drug for Europe

Ionis wins first-ever FDA approval for Alexander disease therapy

Recent BPSI trend: biopharma sentiment improving from pessimism to cautious optimism

Novartis may cut around 130 jobs in Switzerland while relocating biologics production

AbbVie’s T-cell engager shows survival benefit in Phase 3 multiple myeloma study

Pfizer Licenses Out Another Seagen ADC, Raising Fresh Questions About $43 Billion Deal

Novartis’ Rhapsido shows positive Phase 3 MS results, intensifying Roche competition