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Roche (RHHBY) announced the US FDA approval of Rozlytrek for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer. Also, the FDA has granted accelerated approval to Rozlytrek for the treatment of adult and paediatric patients 12 years of age and older with solid tumours that...

AstraZeneca plc (AZN.L, AZN) announced Friday results of Phase III FLAURA trial showing that Tagrisso (osimertinib) significantly improves overall survival for 1st-line EGFR-mutated non-small cell lung cancer or NSCLC. The randomised, double-blinded, multi-centre trial of Tagrisso was in previously-untreated...

AstraZeneca plc (AZN.L, AZN) and Merck & Co., Inc. (MRK) announced Wednesday positive results from the Phase III PROfound trial of Lynparza (olaparib). The trial was in men with metastatic castration-resistant prostate cancer or mCRPC who have a homologous recombination repair gene mutation or HRRm...

Swiss drug major Roche (RHHBY) announced Monday that the Phase III IMvigor130 study met its co-primary endpoint of investigator-assessed progression-free survival or PFS. In the trial, the combination of Tecentriq (atezolizumab) plus platinum-based chemotherapy showed a statistically significant reduction...

dartboard-aug2.jpg Biotech stocks are driven by regulatory and clinical trial catalysts. Knowledge about the timing of FDA decisions and release of clinical trial results will help trade biotech stocks with some margin of safety around the catalyst events.

Novartis (NVS) said that Kisqali significantly prolongs life in women with hormone-receptor positive, human epidermal growth factor receptor-2 negative or HR+/HER2- advanced breast cancer now in two distinct late-stage trials. "We are thrilled that Kisqali combination therapy again has demonstrated...

Swiss drug major Novartis AG (NVS) announced Monday that the global Phase III PARAGON-HF study in heart failure patients with preserved ejection fraction or HFpEF narrowly missed statistical significance for its composite primary endpoint. Meanwhile, overall safety profile confirmed. The trial investigated...

Intec Pharma Ltd. (NTEC) announces Monday top-line data from the Company's pivotal Phase 3 ACCORDANCE trial evaluating the safety and efficacy of the Accordion Pill-Carbidopa/Levodopa (AP-CD/LD) compared with immediate release CD/LD (IR-CD/LD; Sinemet) as a treatment for the symptoms of advanced Parkinson's...

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