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

Merck Reports FDA Approval of Keytruda/Keytruda QLEX + Welireg in Clear Cell Renal Cell Carcinoma

Shots: The US FDA has approved MSD's Welireg + Keytruda/Keytruda QLEX as adj. therapy in clear cell renal cell carcinoma (ccRCC) pts at intermediate-high or high risk of recurrencepost-nephrectomy or post-nephrectomy & resection of metastatic lesions Approval was backed by the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO)…

June 15, 2026

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

HUTCHMED Reports the P-II/III (ESLIM-02) Trial Data on Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia at EHA 2026

Shots: HUTCHMED has reported the P-III data (n=90) from P-II/III (ESLIM-02) assessing sovleplenib in in adult patients with primary or secondary wAIHA who had relapsed or were refractory to prior ≥1L of standard treatment; NDA accepted under NMPA priority review in Apr 2026 Trial met its 1EP of improved durable response rates (66% vs 15%),…

June 12, 2026

Novartis Reports P-III (RemIND) Trial Data on Remibrutinib for Chronic Inducible Urticaria (CIndU)

Shots: Novartis has reported the topline P-III (RemIND) trial data assessing remibrutinib (PO) vs PBO in adults with CIndU inadequately controlled by H1-antihistamines Trial showed higher CR rates at Wk. 12 across symptomatic dermographism (29.3% vs 14%), cold urticaria (56.3% vs 14.6%), & cholinergic urticaria (29.3% vs 15.8%), with responses emerging as early as Wk.…

June 12, 2026

Novo Nordisk Reports the MHRA Approval of Oral Wegovy for Weight Management

Shots: The MHRA has approved Wegovy pill (25mg, QD, PO) as an adjunct to lifestyle intervention for weight management in adults living with obesity or overweight, with ≥1 weight-related condition; launch is expected in select markets by H2’26 Approval was based on the P-III (OASIS 4) trial assessing oral Wegovy vs PBO over 64wks. in…

June 12, 2026

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

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

Akeso Reports the NMPA Approval of Gumokimab to Treat Plaque Psoriasis

Shots: The Chinese NMPA has approved Akeso’s gumokimab (AK111; SC, 17 doses per year, incl. loading) to treat mod. to sev. plaque psoriasis in adults based on the P-III (AK111-301) trial & 3 supportive studies, showing rapid improvement in 2wks. Data showed short-term efficacy, with a PASI 75 response rate approaching 94.6% & PASI 100 reaching…

June 12, 2026

Takeda Reports P-III (LATITUDE Atlas) Trial Data on Zasocitinib for Plaque Psoriasis (PsO)

Shots: Takeda has reported topline P-III (LATITUDE Atlas) trial data assessing zasocitinib (TAK-279; 30mg, PO, QD) vs deucravacitinib (6mg, QD) in 606 adults with mod. to sev. PsO Trial showed that zasocitinib was superior to deucravacitinib in the 1EP, with improved PASI 100 response rates at Wk. 16, plus in all key 2EPs, incl. PASI 90…

June 12, 2026

NEWS

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

Merck Reports FDA Approval of Keytruda/Keytruda QLEX + Welireg in Clear Cell Renal Cell Carcinoma

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

HUTCHMED Reports the P-II/III (ESLIM-02) Trial Data on Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia at EHA 2026

Novartis Reports P-III (RemIND) Trial Data on Remibrutinib for Chronic Inducible Urticaria (CIndU)

Novo Nordisk Reports the MHRA Approval of Oral Wegovy for Weight Management

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

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

Akeso Reports the NMPA Approval of Gumokimab to Treat Plaque Psoriasis

Takeda Reports P-III (LATITUDE Atlas) Trial Data on Zasocitinib for Plaque Psoriasis (PsO)

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