Otsuka Reports the US FDA Approval for Simtriyo to Treat ADHD

Shots: The US FDA has approved Simtriyo (centanafadine) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pts (≥6yrs.; ≥20kg), with availability expected later this year following scheduling by the US DEA Approval was supported by 4 P-III trials assessing Simtriyo vs PBO in children, adolescents, & adults with ADHD In two adult studies, both Simtriyo dose groups…

ByRidhi RastogiJuly 27, 2026

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Nuvectis Pharma Reports NMPA Approval of Ciprocopan for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Shots: The NMPA has approved ciprocopan (NXP100, QD, PO) for the treatment of pts with PNH previously untreated with Complement inhibitors. Application for PNH pts previously treated with anti-C5 therapies is under review in China Approval was based on a P-III trial of ciprocopan vs Soliris in the above-mentioned pts, which met all 1 &…

ByRidhi RastogiJuly 24, 2026

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GSK Reports the US FDA Approval of Jideytro for Previously Treated ROS1-Positive NSCLC

Shots: The US FDA has approved Jideytro (zidesamtinib) for the treatment of adults with locally advanced or metastatic ROS1-positive NSCLC who received a prior ROS1 kinase inhibitor Approval was based on the global P-I/II (ARROS-1) trial evaluating Jideytro in pts (n=117) with advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 inhibitor Trial showed meaningful & durable…

ByRidhi RastogiJuly 23, 2026

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Kyowa Kirin Reports the EC Approval for Crysvita for X-Linked Hypophosphataemia

Shots: The EC has approved an expansion of the indication for Crysvita (burosumab) for the treatment of X-linked hypophosphataemia (XLH), to incl. infants from 1mos. to 1yr. of age Approval was supported by data from P-I/II (BUR-CL207) study assessing safety, tolerability, PK & efficacy of burosumab in pts with XLH from birth to 1yr. Trial showed…

ByRidhi RastogiJuly 21, 2026

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SystImmune Reports the NMPA Approval of Iza-bren to Treat Recurrent or Metastatic ESCC

Shots: The NMPA has approved iza-bren (izalontamab brengitecan) for the treatment of adult pts with recurrent or metastatic ESCC whose disease has progressed following prior Pt-based CT & PD-1/PD-L1 inhibitor therapy Approval was based on the P-III (PANKU-Esophagus01) trial assessing iza-bren vs CT in the above-mentioned pts (n=497) across China, which met its dual 1EP…

ByRidhi RastogiJuly 20, 2026

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Novartis Reports the US FDA’s Traditional Approval of Fabhalta to Treat Primary IgAN

Shots: The US FDA has granted traditional approval to Fabhalta (iptacopan) for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression Approval was based on the P-III (APPLAUSE-IgAN) trial, where Fabhalta slowed eGFR decline by 48% vs PBO over 2yrs., with an annualized mean change from baseline…

ByRidhi RastogiJuly 17, 2026

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Novo Nordisk Reports the EC Approval of Wegovy Pill and Wegovy 7.2mg Injection for Weight Management

Shots: The EC approved Wegovy pill (25mg, QD, PO) as an adjunct to lifestyle intervention for weight management in adults with obesity or overweight, with ≥1 weight-related condition; launch expected in H2’26. The EC also approved Wegovy 7.2mg injection in a single-dose pen for obesity Wegovy pill approval was based on the OASIS clinical trial…

ByRidhi RastogiJuly 16, 2026

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Eisai and Biogen Report US FDA Approval of Leqembi Iqlik as an Initiation Dose for Early Alzheimer’s Disease

Shots: The US FDA has approved an sBLA for Leqembi Iqlik (lecanemab‑irmb, SC) as an initiation dose administered as 500mg given QW as two 250mg injections, each delivered in ~15secs for the treatment of early Alzheimer's disease Approval was supported by clinical data across multiple studies, with Clarity AD LTE sub-studies showing QW SC Leqembi…

ByRidhi RastogiJuly 14, 2026

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The US FDA Approves Sanofi’s Sarclisa Escena to Treat Multiple Myeloma (MM)

Shots: The US has approved Sarclisa Escena (isatuximab-irfc; SC) + SoC for the treatment of pts with MM across all existing indications of Sarclisa IV formulation Approval was backed by multiple trials, incl. P-III (IRAKLIA) in R/R MM, which showed shorter treatment time & fewer infusion-related reactions with Sarclisa Escena In IRAKLIA, SC Sarclisa delivered…

ByRidhi RastogiJuly 13, 2026

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Merck, Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Cisplatin-Eligible MIBC Patients

Shots: The US FDA has approved Padcev (enfortumab vedotin) + Keytruda/Keytruda Qlex for neoadj. & adj. treatment for pts with muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility Approval was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs neoadj. SoC + surgery in cisplatin-eligible MIBC…

ByRidhi RastogiJuly 13, 2026

Otsuka Reports the US FDA Approval for Simtriyo to Treat ADHD

Nuvectis Pharma Reports NMPA Approval of Ciprocopan for Paroxysmal Nocturnal Hemoglobinuria (PNH)

GSK Reports the US FDA Approval of Jideytro for Previously Treated ROS1-Positive NSCLC

Kyowa Kirin Reports the EC Approval for Crysvita for X-Linked Hypophosphataemia

SystImmune Reports the NMPA Approval of Iza-bren to Treat Recurrent or Metastatic ESCC

Novartis Reports the US FDA’s Traditional Approval of Fabhalta to Treat Primary IgAN

Novo Nordisk Reports the EC Approval of Wegovy Pill and Wegovy 7.2mg Injection for Weight Management

Eisai and Biogen Report US FDA Approval of Leqembi Iqlik as an Initiation Dose for Early Alzheimer’s Disease

The US FDA Approves Sanofi’s Sarclisa Escena to Treat Multiple Myeloma (MM)

Merck, Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Cisplatin-Eligible MIBC Patients

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