Regulatory Approvals
Page 1 • 9 itemsTrack global regulatory approvals for new drugs and biologics. Stay ahead in pharma BD with critical FDA, EMA, and PMDA insights.
FDA Approves Palazestrant for Breast Cancer Amidst Data Concerns
The U.S. Food and Drug Administration (FDA) has granted approval for palazestrant, a novel breast cancer treatment developed by Pfizer and Arvinas. This decision comes despite some concerns raised about the drug's clinical trial data, marking a significant development in breast cancer therapy.
FDA Approval for Pfizer's Breast Cancer Drug: Vepdegestrant
The FDA has granted approval for Pfizer and Arvinas' novel breast cancer drug, vepdegestrant. This marks a significant new treatment option for patients with advanced or metastatic HR-positive, HER2-negative breast cancer who have exhausted prior endocrine therapies.
Axsome FDA Approval for Alzheimer's Agitation Drug
Axsome Therapeutics has received FDA approval for a new treatment for agitation associated with Alzheimer's disease. This landmark decision addresses a critical unmet need and marks a significant step forward for the company and Alzheimer's patient care.
FDA Approves First Non-Antipsychotic for Dementia Agitation
The FDA has approved the first non-antipsychotic medication for agitation linked to dementia from Alzheimer's disease. This landmark approval provides a much-needed alternative to antipsychotics, which carry significant risks for this patient population.
Auvelity FDA Approval: New MDD Treatment Option
The FDA has approved Auvelity, a new oral treatment for major depressive disorder (MDD) in adults, marking a significant advancement in mental health therapeutics. Manufactured by Axsome Therapeutics, this approval offers a novel option for patients seeking relief from MDD.
Plozasiran TGA Approval: REDEMPLO® Now Available in Australia for FCS
Arrowhead Pharmaceuticals has secured TGA approval for REDEMPLO® (plozasiran) in Australia, marking a significant step in providing treatment options for patients with Familial Chylomicronemia Syndrome (FCS). This approval expands global access to the novel therapy for this rare genetic disorder.
Plozasiran TGA Approval: REDEMPLO® Expands FCS Access in Australia
Arrowhead Pharmaceuticals has secured TGA approval for REDEMPLO® (plozasiran) in Australia, marking a significant step in providing a new treatment option for patients with Familial Chylomicronemia Syndrome (FCS). This approval broadens global access to plozasiran for this rare genetic disorder.
Teva Reports Strong Q1 2026 Results as PONLIMSI Biosimilar Receives FDA Approval and Olanzapine LAI Advances
Teva's Q1 2026 earnings show strong performance driven by PONLIMSI biosimilar FDA approval and olanzapine LAI NDA acceptance for schizophrenia treatment.
CGBIO Receives FDA 510(k) Clearance for EASYMADE TI Patient-Specific Titanium Implant
CGBIO becomes first Korean company to receive FDA 510(k) clearance for patient-specific titanium implant EASYMADE TI, marking regulatory milestone.