Shots:
The US FDA has accepted the NDA of bezuclastinib for the treatment of NonAdvSM, with no advisory committee meeting planned or review issues identified yet (PDUFA: Dec 30, 2026)
NDA was backed by SUMMIT trial, which met its 1 & 2EPs, showing sustained, deepening clinical benefit through 48wks., plus impact on bone mineral density…
NEWS
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Ascendis Pharma has reported the P-II (New InsiGHTS) trial data assessing TransCon hGH (lonapegsomatropin, QW) vs somatropin (QD) in 49 prepubertal children (1-10yrs.) with Turner syndrome
At Wk. 52, TransCon hGH showed improved annualized height velocity (AHV) with LS mean AHV of 9.05 vs 9.04 cm/year, irrespective of starting dose, with mean dose of…
Shots:
Voro Therapeutics has entered into a research collaboration with Daiichi Sankyo via its Daiichi Sankyo Research Institute, San Diego to develop tumor-activated biologics using the PrimeBody platform
The collaboration will focus on generating masked ADCs designed for tumor-selective activation, using proprietary masking domains & protease-cleavable linkers to improve therapeutic index
Voro will design &…
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Pfizer has reported P-II (FOURLIGHT-1) trial data assessing atirmociclib + fulvestrant vs fulvestrant or everolimus plus exemestane in 264 pts with HR+, HER2- advanced or metastatic breast cancer who had received prior CDK 4/6 inhibitor-based treatment
Trial met its 1EP, showing improved PFS as assessed by the investigator, with benefit consistent across all subgroups. OS…
Shots:
The US FDA has accepted sBLA of Ilumya (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis (PsA), with PDUFA target action date of Oct 29, 2026
sBLA was backed by P-III (INSPIRE-1 & INSPIRE-2) trials assessing Ilumya (100mg) in pts with PsA over 52wks., where INSPIRE-1 enrolled pts with prior anti-TNF exposure…
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The EC has approved perioperative Imfinzi + FLOT for adults with resectable, early-stage & locally advanced (Stages II, III, IVA) G/GEJ cancers, based on P-III (MATTERHORN) trial; regulatory review is ongoing in Japan
In the trial, Pts (n=948) received either Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W × 2 cycles, then surgery followed by…
Shots:
Celltrion launched Avtozma SC, a biosimilar to Actemra (tocilizumab), in the US, becoming among the first to offer both IV & SC formulations approved by the US FDA & available in the market
Avtozma received the FDA & EC approval in Jan & Feb 2025, respectively, based on a global P-III trial showing comparable…
Shots:
The US FDA has granted 510(k) clearance to the Urocross Expander System for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH), backed by extensive data incl. the Expander-1 & Expander-2 trials
Expander-2 (n=240) showed mean 48.1% IPSS improvement & a 74.5% responder rate (≥30% IPSS reduction) at 12mos. post implantation…
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The P-III (ADorable‑1) study data assessed Ebglyss vs PBO in 363 pediatric pts (≥6mos.) with mod. to sev. AD; Topical corticosteroids were required for 2 wks. pre-randomization through Wk. 16, with tapering or discontinuation allowed once pts achieved IGA ≤2
At Wk. 16, the trial met it 1EP & key 2EPs, with 63% vs…
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Sana has reported 14mos. follow-up data from a FIH study of UP421, a hypoimmune-engineered allogeneic islet cell therapy, transplanted into a patient with Type 1 Diabetes without immunosuppression
Results showed sustained survival & function of pancreatic β cells. At 14mos., fasting & MMTT C-peptide levels matched the first 6mos. & exceeded in mos. 9-12,…

