Innovent Biologics Reports the Chinese NMPA Approval of Pecondle (Picankibart) to Treat Plaque Psoriasis

Shots: The Chinese NMPA has approved Pecondle (picankibart) for the treatment of mod. to sev. plaque psoriasis (PsO) in adults who are candidates for systematic therapy Approval was supported by the P-III (CLEAR-1) trial in Chinese pts with mod. to sev. PsO, where picankibart demonstrated significantly higher PASI 90 (1EP; 80.3% vs 2%) & sPGA 0/1…

ByRidhi RastogiNovember 28, 2025

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Eisai and Biogen Seek Japanese PMDA Approval for Leqembi SC (Lecanemab) to Treat Early Alzheimer’s Disease

Shots: The Japanese PMDA has received NDA for Leqembi SC autoinjector to treat adults with early Alzheimer’s disease (AD) NDA is supported by sub-studies from the P-III (Clarity AD) OLE study in pts with mild cognitive impairment due to AD or mild AD dementia, showing that Leqembi (500mg, SC: two 250mg injections) administered QW, provided exposure equivalent to Q2W IV…

ByRidhi RastogiNovember 28, 2025

NEWS

Cothera Bioscience’s Zotiraciclib Receives the US FDA Fast Track Designation for Recurrent IDH-Mutated High-Grade Glioma

Shots: The US FDA has granted FTD to zotiraciclib (ZTR/TG02) for the treatment of pts with recurrent high-grade gliomas (rHGG) harboring IDH1 or IDH2 mutations (IDHmut rHGG) Designation was backed by the completion of the P-I trial of zotiraciclib, showing preliminary efficacy & favorable safety as a monotx. in IDHmut rHGG pts, which was presented at…

ByRidhi RastogiNovember 27, 2025

NEWS

Novo Nordisk Reports the US FDA’s sNDA Submission for Higher Wegovy Dose for Weight Management

Shots: The US FDA has received an sNDA for a higher dose of Wegovy (7.2mg semaglutide) along with lifestyle intervention for chronic weight management in adults with obesity, with sNDA to be reviewed under CNPV program sNDA was supported by 72wk. STEP UP trial assessing Wegovy (7.2mg, QW) vs Wegovy (2.4mg) & PBO alongside lifestyle intervention in 1,407 obese…

ByRidhi RastogiNovember 27, 2025

NEWS

BeOne Medicines Reports the US FDA’s NDA Acceptance of Sonrotoclax with Priority Review for R/R Mantle Cell Lymphoma

Shots: The US FDA has accepted NDA & granted priority review to sonrotoclax for adults with r/r mantle cell lymphoma following treatment with a BTK inhibitor NDA was supported by the global P-I/II (BGB-11417-201) assessing sonrotoclax in r/r MCL pts (n=125), which met its 1EP of improved ORR per IRC, with benefits seen across…

ByRidhi RastogiNovember 26, 2025

NEWS

AstraZeneca Secures the US FDA Approval of Imfinzi as a Perioperative Therapy for G/GEJ Cancers

Shots: FDA has approved perioperative Imfinzi for adults with resectable, early-stage & locally advanced (Stages II, III, IVA) G/GEJ cancers, with submission reviewed under Project Orbis & based on P-III (MATTERHORN) trial; regulatory review is ongoing in the EU & Japan In the trial, Pts (n=948) received Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W ×…

ByRidhi RastogiNovember 26, 2025

NEWS

Otsuka Pharmaceutical Receives the US FDA Accelerated Approval for Primary Immunoglobulin A Nephropathy (IgAN)

Shots: The US FDA has granted accelerated approval to Voyxact (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary IgAN at risk for disease progression Approval was based on the interim data from the ongoing P-III (VISIONARY) trial, assessing Voyxact (400mg, SC, Q4W) vs PBO in 510 IgAN adults, who were on SoC therapy Trial…

ByRidhi RastogiNovember 26, 2025

NEWS

Regeneron and Sanofi Report the EC Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Shots: The EC has approved Dupixent to treat mod. to sev. CSU pts (≥12yrs.), who were symptomatic despite H1 antihistamine treatment & naïve to anti-IgE therapy based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program Study A & C (N=284) assessed Dupixent + SoC antihistamines (loading dose then 300mg Q2W; pts weighing <60kg…

ByRidhi RastogiNovember 25, 2025

NEWS

Novartis’ Itvisma Receives the US FDA Approval for Spinal Muscular Atrophy

Shots: The US FDA has approved Itvisma (onasemnogene abeparvovec-brve) for the treatment of pts (≥2yrs.) living with spinal muscular atrophy (SMA) harboring a confirmed mutation in the SMN1 gene; US availability expected in Dec 2025 Approval was based on the P-III (STEER) trial & open-label P-IIIb (STRENGTH) study, showing Itvisma improved motor function & stabilized…

ByRidhi RastogiNovember 25, 2025

NEWS

BMS’ Breyanzi Receives the EC Approval to Treat R/R Mantle Cell Lymphoma

Shots: The EC has approved Breyanzi (lisocabtagene maraleucel) for the treatment of adults with r/r mantle cell lymphoma (MCL) after ≥2L of systemic therapy, incl. a BTK inhibitor, in all 30 EEA states Approval was based on the MCL cohort of the P-I (TRANSCEND NHL 001) trial assessing Breyanzi in adults with r/r B-cell non-Hodgkin…

ByRidhi RastogiNovember 25, 2025

Innovent Biologics Reports the Chinese NMPA Approval of Pecondle (Picankibart) to Treat Plaque Psoriasis

Eisai and Biogen Seek Japanese PMDA Approval for Leqembi SC (Lecanemab) to Treat Early Alzheimer’s Disease

Cothera Bioscience’s Zotiraciclib Receives the US FDA Fast Track Designation for Recurrent IDH-Mutated High-Grade Glioma

Novo Nordisk Reports the US FDA’s sNDA Submission for Higher Wegovy Dose for Weight Management

BeOne Medicines Reports the US FDA’s NDA Acceptance of Sonrotoclax with Priority Review for R/R Mantle Cell Lymphoma

AstraZeneca Secures the US FDA Approval of Imfinzi as a Perioperative Therapy for G/GEJ Cancers

Otsuka Pharmaceutical Receives the US FDA Accelerated Approval for Primary Immunoglobulin A Nephropathy (IgAN)

Regeneron and Sanofi Report the EC Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Novartis’ Itvisma Receives the US FDA Approval for Spinal Muscular Atrophy

BMS’ Breyanzi Receives the EC Approval to Treat R/R Mantle Cell Lymphoma

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