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Astrazeneca
NEWS

AstraZeneca Reports FDA’s sBLA Acceptance Under Priority Review for Ultomiristo Treat IgA Nephropathy

Shots: The US FDA has accepted sBLA & granted priority review to AZ's Ultomiris (ravulizumab) for the treatment of adults with immunoglobulin A nephropathy (IgAN), with a PDUFA action date anticipated in Q4’26 sBLA was supported by the interim analysis data from the global P-III (I CAN/ALXN1210-IgAN-320) trial assessing Ultomiris (IV) vs PBO in ~510 adults with…
June 15, 2026

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Sanofi
NEWS

Sanofi’s Tzield Secures FDA Accelerated Approval to Preserve Endogenous Insulin Production in Recently Diagnosed Stage 3 T1D

Shots: The US FDA has granted accelerated approval to Sanofi's Tzield to delay the decline in endogenous (own) insulin production in pts (8-17yrs.) recently diagnosed with stage 3 T1D Approval was based on the P-III (PROTECT) trial assessing Tzield (n=217) vs PBO (n=111) in 328 children & adolescents (8-17yrs.) diagnosed with clinical stage 3 T1D…
June 15, 2026

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Astrazeneca
NEWS

AstraZeneca’s Truqap Combination Receives the US FDA Approval for PTEN-Deficient mAPMN/S Prostate Cancer

Shots: FDA has approved AZ's Truqap + abiraterone & ADT, along with its companion diagnostic test for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer; regulatory review is ongoing in the EU Approval was based on the global P-III (CAPItello-281) trial assessing Truqap + abiraterone & ADT vs PBO + abiraterone…
June 15, 2026

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NEWS

Wave Neuroscience’s MeRT System Receives the US FDA Clearance for PTSD

Shots: The US FDA has granted clearance to the Magnetic EEG-guided Resonance Therapy (MeRT) System, a personalized, biomarker-guided neuromodulation technology for Post-Traumatic Stress Disorder (PTSD) Clearance was supported by a trial conducted with investigators from Texas A&M Health Institute of Biosciences & Technology, demonstrating that MeRT significantly reduced PTSD symptom severity with clinically meaningful improvements…
June 12, 2026

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Bayer
NEWS

Bayer Reports the US FDA Approval of Ambelvist to Enhance MRI Detection of Lesions 

Shots:  The US FDA has approved Ambelvist (gadoquatrane) for contrast-enhanced MRI to detect lesions with abnormal vascularity in the CNS and other body regions in adults and pediatric patients, including term neonates  Approval was supported by the global P-III (QUANTI) studies, which demonstrated that Ambelvist improved lesion visualization at a lower gadolinium dose (0.04 mmol Gd/kg) while providing diagnostic performance…
June 12, 2026

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NEWS

Organon Receives the US FDA Approval for the sBLA for Tofidence (Biosimilar, Actemra) 

Shots:  The US FDA has approved sBLA for Tofidence, a biosimilar version of Actemra (tocilizumab)  Tofidence is an IL-6 receptor antagonist available in 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL single-dose vials for IV. The expanded approval adds indications for CAR T cell-induced severe or life-threatening cytokine release syndrome (CRS) and hospitalized adults and children (≥2 years) with COVID-19 requiring…
June 10, 2026

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Eli lilly
NEWS

Eli Lilly Receives the US FDA Approval for Ebglyss as a Q8W Maintenance Therapy for Atopic Dermatitis

Shots: The US FDA has approved Ebglyss (lebrikizumab-lbkz; 250mg/2mL, Q8W, SC) maintenance therapy for the treatment of pts (≥12yrs.; ≥40kg) with mod. to sev. atopic dermatitis Approval was supported by longitudinal exposure-response modeling & Q8W dosing data from an extension of the P-III (Adjoin) long-term trial, which assessed Ebglyss maintenance dosing for Q4W or Q8W over…
June 10, 2026

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INSIGHTS+

The US FDA New Drug Approvals in May 2026 

Shots:  The US FDA approved eight therapies in May 2026 across oncology, cardiovascular disease, infectious diseases, anesthesia, and antimicrobial resistance, reflecting continued regulatory momentum in addressing both rare and prevalent diseases.   Key approvals included Veppanu (breast cancer), Beqalzi (mantle cell lymphoma), Baxfendy (hypertension), Hepcludex (HDV infection), Decnupaz (BPDCN), Zaynich (cUTI), Cypsedo (general anesthesia), and Xocova (COVID-19 PEP).   Overall, May 2026 underscored the FDA’s commitment to advancing innovative medicines, precision therapies, and expanded patient access,…
June 9, 2026

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