FDA approval

FDA Approval of Zepzelca® (Lurbinectedin) Plus Tecentriq® (Atezolizumab) for Extensive-Stage Small Cell Lung Cancer

FDA grants approval for Zepzelca + Tecentriq combination in first-line ES-SCLC, offering a new immunotherapy-chemotherapy treatment option.

Rhapsido

Novartis’ Rhapsido® (remibrutinib) FDA-Approved as First Oral BTK Inhibitor for Chronic Spontaneous Urticaria

Novartis’ Rhapsido® (remibrutinib) receives FDA approval as the first oral BTK inhibitor for chronic spontaneous urticaria (CSU). Filed in EU, Japan, and China (priority review).

FDA approval

FDA Approves Imlunestrant for ESR1-Mutated ER+, HER2- Breast Cancer

The FDA has approved imlunestrant (Inluriyo) for ESR1-mutated ER+, HER2- metastatic breast cancer. With elacestrant already on the market, patients now have two oral SERDs — raising questions of sequencing, safety, and access.

Forzinity

From Discovery to FDA Approval: Forzinity Becomes First Therapy for Barth Syndrome

Forzinity (elamipretide) makes history as the first FDA-approved therapy for Barth syndrome. Learn about Hazel Szeto’s discovery, Stealth Biotherapeutics’ development journey, and the clinical evidence supporting approval.

Keytruda Subcutaneous Injection

Keytruda Subcutaneous Injection Receives FDA Approval: 1–2 Minute Dosing for Most Solid Tumors

Merck’s Keytruda subcutaneous injection (MK-3475A, Keytruda Qlex) approved by FDA, offering 1–2 minute dosing for adult patients with most solid tumors.