EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Vijoice to treat adults and children aged 2 years and older with severe or life-threatening PIK3CA-related overgrowth spectrum (PROS) disorders.
EMA has recommended an extension to the marketing authorisation for Wegovy (semaglutide) in the EU to add an oral formulation for weight management. Wegovy tablets can be used, together with diet and physical activity, in adults with obesity, or in those who are overweight and have at least one weight-related comorbidity. This is the first glucagon-like peptide …
EMA: First oral GLP-1 treatment for weight management Read More »
EMA has recommended granting a marketing authorisation in the European Union (EU) for Jascayd (nerandomilast) to treat adults with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF), two serious lung diseases that involve progressive and irreversible scarring (fibrosis) of the lung tissue.
On May 22, 2026, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
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
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.
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 …
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 …
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 …
