The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3 to 6 against recommending camizestrant in combination with a CDK4/6 inhibitor
The Committee backed the combination based on results from the CAPItello-281 Phase III trial, marking a key milestone in the regulatory pathway for AstraZeneca’s targeted therapy strategy in prostate cancer
The newly formed SAB will provide strategic direction across research, clinical development, and regulatory pathways
As part of the deal, Red Nucleus also gains indirect ownership of the company’s Indian arm
MedTech Mitra initiative aims to empower MedTech innovators and advance healthcare solutions
States urged to maintain a state of constant vigil through screening of pregnant women for Zika virus infection and monitoring the growth of foetus of expecting mothers who tested positive for Zika
Patient Advisory Councils (PACs) to be set up across hospitals to make patients true partners in enhancing patient safety and improving care delivery
The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients
She will provide strategic advice and scientific leadership to support clients in clinical development, registration strategy, submission, early post-approval strategy
During her tenure at the University of South Florida Dr. Hunter was responsible for managing the patent portfolio associated with Alzamend’s two product candidates, AL001 and AL002
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