Sun Pharma Reports US FDA’s sBLA Acceptance of Ilumya for Active Psoriatic Arthritis

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…

ByRidhi RastogiMarch 17, 2026

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

Shots: 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…

ByRidhi RastogiMarch 17, 2026

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Eli Lilly Reports P-III (ADorable 1) Trial Data on Ebglyss (Lebrikizumab-lbkz) in Atopic Dermatitis (AD)

Shots: 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…

ByRidhi RastogiMarch 17, 2026

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Bayer Reports the P-III (FIND-CKD) Trial Data on Kerendia in Non-Diabetic Chronic Kidney Disease

Shots: Bayer has reported the P-III (FIND-CKD) trial data assessing Kerendia (finerenone; 10 or 20mg) vs PBO, both in addition to SoC, in >1,500 adults with non-diabetic chronic kidney disease Trial met its 1EP, showing a statistically significant improvement in eGFR slope, defined as the mean annual change in eGFR from baseline to Month 32; data…

ByRidhi RastogiMarch 16, 2026

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Otsuka Pharmaceutical Reports OLE Study Data on Repinatrabit in Phenylketonuria

Shots: OLE study assessed repinatrabit (JNT-517) in adolescents with PKU. Early time-point data remain embargoed to preserve parent-study blinding, with additional randomized-period results to be presented later First cohort receiving repinatrabit (75mg, PO, BID) showed a 67% mean reduction in Phe from baseline (Day 56/OLE Month 1), with responses seen in all pts, incl. prior…

ByRidhi RastogiMarch 13, 2026

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Ultragenyx Reports the P-III (Enh3ance) Trial for DTX301 AAV8 Gene Therapy in OTC Deficiency

Shots: Ultragenyx has reported the P-III (Enh3ance) study data assessing DTX301 AAV8 gene therapy vs PBO for the treatment of ornithine transcarbamylase (OTC) deficiency DTX301 reduced 24hr. plasma ammonia by 18% vs PBO at Wk. 36, with ammonia levels maintained in the normal range, despite a 27% mean decrease in scavenger drugs & ~13% increase…

ByRidhi RastogiMarch 13, 2026

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Johnson & Johnson Submits Tecvayli Application to EMA for R/R Multiple Myeloma

Shots: The EMA has received the Type II variation application for Tecvayli monotx. (teclistamab) for the treatment of adults with r/r multiple myeloma (RRMM) who have received ≥1 prior therapy Application was supported by the P-III (MajesTEC-9) trial assessing Tecvayli vs SoC of pomalidomide, bortezomib, & dexamethasone (PVd) or carfilzomib & dexamethasone (Kd) in 614…

ByRidhi RastogiMarch 12, 2026

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Curatis Grants Neupharma Japan Rights to Corticorelin for Brain Edema

Shots: Curatis & Neupharma have entered into an exclusive license & development agreement for Corticorelin (C‑PTBE‑01) in Japan to treat Peritumoral Brain Edema As per the deal, Neupharma will develop & commercialize corticorelin in Japan & fund a pivotal trial to support PMDA approval, in exchange of upfront & regulatory & commercial milestones totaling up…

ByRidhi RastogiMarch 11, 2026

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LENZ Therapeutics Reports EMA’s MAA Submission for Vizz to Treat Presbyopia

Shots: The EMA has received MAA of Vizz (1.44% aceclidine ophthalmic solution) for the treatment of presbyopia in adults MAA was supported by the 3 P-III (CLARITY) trials evaluating Vizz (QD) across the US, in which Vizz met all 1 & 2EPs, showing rapid near vision improvement within 30min., lasting up to 10hrs. Additionally, LENZ…

ByRidhi RastogiMarch 11, 2026

NEWS

Johnson & Johnson Gains EC Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The EC has approved Akeega (niraparib & abiraterone acetate tablet) + prednisone/prednisolone + androgen deprivation therapy (ADT) to treat adults with mHSPC & BRCA1/2 mutations Approval was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/ prednisolone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC…

ByRidhi RastogiMarch 10, 2026

Sun Pharma Reports US FDA’s sBLA Acceptance of Ilumya for Active Psoriatic Arthritis

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

Eli Lilly Reports P-III (ADorable 1) Trial Data on Ebglyss (Lebrikizumab-lbkz) in Atopic Dermatitis (AD)

Bayer Reports the P-III (FIND-CKD) Trial Data on Kerendia in Non-Diabetic Chronic Kidney Disease

Otsuka Pharmaceutical Reports OLE Study Data on Repinatrabit in Phenylketonuria

Ultragenyx Reports the P-III (Enh3ance) Trial for DTX301 AAV8 Gene Therapy in OTC Deficiency

Johnson & Johnson Submits Tecvayli Application to EMA for R/R Multiple Myeloma

Curatis Grants Neupharma Japan Rights to Corticorelin for Brain Edema

LENZ Therapeutics Reports EMA’s MAA Submission for Vizz to Treat Presbyopia

Johnson & Johnson Gains EC Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

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