Drug Approval | February 21, 2026
FDA accepts Roche’s new drug application for Giredestrant in advanced breast cancer
The NDA filing is supported by results from the phase III evERA Breast Cancer study
The NDA filing is supported by results from the phase III evERA Breast Cancer study
The results mark a potential breakthrough for patients living with CIndU, a condition with limited treatment options
The trial targeted a patient population with high BMI and extensive skin involvement, averaging over 39 kg/m²
The approval is based on the SWIFT and ANCHOR phase III trials, which demonstrated sustained efficacy with a twice-yearly dosing regimen
ANYRA is India’s first indigenously developed Aflibercept 2 mg biosimilar
TED?A9 is part of S.Biomedics’ expanding pipeline of stem-cell-based therapies, developed using the company’s proprietary targeted embryonic stem cell differentiation platform
BREAKWATER is a Phase 3, randomized, open-label trial testing BRAFTOVI in combination with cetuximab, either alone or with chemotherapy, in patients with untreated BRAF V600E-mutant mCRC
The therapy, also known as UM171 Cell Therapy, recently received conditional marketing authorization from the European Commission
The trial, which compared Retevmo to placebo, met its primary endpoint with a “highly statistically significant and clinically meaningful improvement” in investigator-assessed EFS for patients with stage II–IIIA disease
Primary membranous nephropathy is a chronic autoimmune disease that attacks the kidneys’ filtering units
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