EU tracks progress towards 2030 clinical trial targets
19 multinational clinical trials have been authorised in addition to the historical average; 40.5% of the total number of clinical trials recruit participants within 200 days
FDA publishes new product-specific guidances to facilitate generic drug development
Today, FDA published a new batch of draft product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating evidence to support abbreviated new drug application (ANDA) approvals.
FDA approves atezolizumab for adjuvant treatment of muscle invasive bladder cancer in patients with molecular residual disease
On May 15, 2026, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) as adjuvant treatments for adults with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) as determined by an FDA-authorized test. Today, the FDA also …
FDA approves first interchangeable biosimilars to Simponi and Simponi Aria (golimumab) to treat rheumatoid arthritis and ulcerative colitis
On May 15, 2026, the Food and Drug Administration FDA approved Immgolis (golimumab-sldi) as an interchangeable biosimilar biological product to Simponi (golimumab) and Immgolis Intri (golimumab-sldi) as an interchangeable biosimilar biological product to Simponi Aria (golimumab) to treat rheumatoid arthritis and ulcerative colitis. Immgolis and Immgolis Intri are the first biosimilars approved for Simponi and Simponi Aria, respectively. Immgolis is administered by subcutaneous injection in a single-dose prefilled syringe and Immgolis Intri is administered …
FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer
On May 15, 2026, the Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu, Daiichi Sankyo, Inc.) for two separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for T-DXd followed by a taxane, trastuzumab, and pertuzumab (THP), for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or …
EMA welcomes political agreement on Critical Medicines Act
EMA welcomes the provisional agreement reached by the European Parliament and the Council of the European Union on the proposed Critical Medicines Act (CMA), which represents an important step in strengthening the resilience, security and sustainability of the European Union’s supply of critical medicines.
EMA actively monitoring cruise ship Hantavirus outbreak
EMA is actively monitoring the ongoing hantavirus outbreak linked to a cruise ship, in coordination with other EU bodies. The virus has been identified as Andes hantavirus, the only hantavirus that can be transmitted person-to-person, typically requiring close, prolonged contact. Based on the available evidence so far, the European Centre for Disease Prevention and Control (ECDC) …
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FDA approves oral combination of decitabine and cedazuridine tablets with venetoclax for newly diagnosed acute myeloid leukemia
On May 13, 2026, the Food and Drug Administration approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology, Inc.) with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma
On May 13, 2026, the Food and Drug Administration granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines USA, Inc.), a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
FDA Alerts Health Care Providers and Patients about Increased Risk of New Blood Cancers with Tazverik (tazemetostat) Use; Sponsor to Voluntarily Withdraw Product from Market
The U.S. Food and Drug Administration (FDA) is alerting patients and health care providers about the voluntary withdrawal of Tazverik (tazemetostat) tablets from the market due to an increased rate of hematologic second primary malignancies (SPMs) — the development of new blood cancers in people treated with Tazverik for a different cancer. As a result, …