MEDIPOST Reports P-III Trial Data in Japan for Cartistem in Knee Osteoarthritis

Shots: MEDIPOST has reported the P-III trial data assessing Cartistem (n=59) vs hyaluronic acid (n=61) in 130 knee osteoarthritis pts over a 52wk. follow-up period across 13 Japanese sites Trial met both co-1EPs of WOMAC knee pain & function scores, and ICRS cartilage repair grading. Improvements were also observed across all 2EPs, incl. VAS pain…

ByRidhi RastogiMay 15, 2026

NEWS

AstraZeneca’s Fasenra Receives the US FDA Approval for Hypereosinophilic Syndrome

Shots: The US FDA has approved AstraZeneca's Fasenra (benralizumab) for the treatment of pts (≥12yrs.) with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause Approval was based on the P-III (NATRON) trial data assessing Fasenra (30mg, SC, Q4W) vs PBO, both in addition to background HES therapy in 133 HES pts for 24wks. Trial met…

ByRidhi RastogiMay 15, 2026

NEWS

AstraZeneca Reports the P-III (VOLGA) Trial Data on Imfinzi + Enfortumab Vedotin (EV) for Muscle-Invasive Bladder Cancer

Shots: Trial enrolled 695 MIBC pts undergoing radical cystectomy who were ineligible for or declined cisplatin & randomized them to Arm 1 [neoadj. 3 Imfinzi + EV cycles with Imjudo (2 cycles), then adj. Imfinzi (9 cycles) + 1 Imjudo cycle], Arm 2 [neoadj. Imfinzi + EV (3 cycles), then adj. Imfinzi (9 cycles)], or…

ByRidhi RastogiMay 14, 2026

NEWS

BeOne Medicines Receives US FDA Accelerated Approval for Beqalzi (Sonrotoclax) to Treat R/R Mantle Cell Lymphoma

Shots: The US FDA has granted accelerated approval to BeOne's Beqalzi for the treatment of adults with r/r mantle cell lymphoma, after ≥2L of systemic therapy, incl. a BTK inhibitor; regulatory review is ongoing in the EU Approval was supported by the global P-I/II (BGB-11417-201) assessing Beqalzi in r/r MCL pts (n=125), which showed 52%…

ByRidhi RastogiMay 14, 2026

NEWS

Fosun Pharma Obtains Option on AriBio’s Alzheimer’s Disease (AD) Therapy AR1001

Shots: Fosun Pharma & AriBio have entered into an exclusive global option agreement for the development, registration, manufacturing, & commercialization of AR1001 for AD, expanding their partnership beyond Greater China & 10 ASEAN countries AriBio will receive a $60M option fee & retain the right to exercise the option within the agreed period, while Fosun…

ByRidhi RastogiMay 14, 2026

NEWS

AstraZeneca Presents the P-III (CALYPSO) Trial Data on Eneboparatide in Chronic Hypoparathyroidism (HypoPT) at ECE’26

Shots: Trial assessed eneboparatide (ENB; QD, SC) vs PBO for 24wks. in 202 adults with HypoPT on active vitamin D & oral Ca supplements; Pts then continued ENB (ENB/ENB) or switched from PBO to ENB (PBO/ENB) in a 28wk. OLE Trial met its composite 1EP, with 31.1% pts achieving normalized albumin-adjusted sCa levels & independence…

ByRidhi RastogiMay 13, 2026

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argenx Reports the US FDA Approval of Vyvgart and Vyvgart Hytrulo for Generalized Myasthenia Gravis

Shots: The US FDA has approved the label expansion of argenx's Vyvgart (efgartigimod alfa-fcab) & Vyvgart Hytrulo (efgartigimod alfa & hyaluronidase-qvfc) for the treatment of adult pts with gMG, expanding its use in all serotypes of gMG Approval was based on the P-III (ADAPT SERON) study assessing efgartigimod vs PBO in gMG pts (n=119) who…

ByRidhi RastogiMay 11, 2026

NEWS

BMS’ Sotyktu (Deucravacitinib) Wins EC Approval to Treat Adults with Active Psoriatic Arthritis (PsA)

Shots: FDA has approved BMS' Sotyktu (6mg, PO, QD) ± methotrexate for adults with active PsA who have had an inadequate response or were intolerant to a prior disease-modifying antirheumatic (DMARD) therapy Approval was based on P-III trials, incl. POETYK PsA-1, involving 670 bDMARD-naïve pts, and POETYK PsA-2, involving 624 pts who were bDMARD-naïve &…

ByRidhi RastogiMay 11, 2026

NEWS

Beacon Therapeutics Reports P-II (DAWN) Trial Data on Laru-zova in X-Linked Retinitis Pigmentosa (XLRP)

Shots: Beacon has reported the 12mos. data from P-II (DAWN) trial assessing laruparetigene zovaparvovec (laru-zova) in pts with XLRP who have previously been treated with an AAV vector-based gene therapy delivering the full-length RPGR protein Data showed sustained improvements in low luminance visual acuity (LLVA) & microperimetry mean sensitivity through Mos. 12, with 50% of…

ByRidhi RastogiMay 8, 2026

NEWS

Incyte Reports 24-week P-III (TRuE-AD4) Trial Data on Opzelura (Ruxolitinib) Cream in Moderate Atopic Dermatitis (AD)

Shots: The P-III (TRuE-AD4) study assessed Incyte's Opzelura cream (BID) vs vehicle in 241 adults with mod. AD who had an inadequate response, intolerance, or contraindication to topical corticosteroids (TCSs) & calcineurin inhibitors (TCIs); data presented at EADV’26 As previously reported, the study met its co-1EPs, with 83.5% pts achieving EASI75 & 74.4% reaching IGA-TS, while 74.3% pts…

ByRidhi RastogiMay 8, 2026

MEDIPOST Reports P-III Trial Data in Japan for Cartistem in Knee Osteoarthritis

AstraZeneca’s Fasenra Receives the US FDA Approval for Hypereosinophilic Syndrome

AstraZeneca Reports the P-III (VOLGA) Trial Data on Imfinzi + Enfortumab Vedotin (EV) for Muscle-Invasive Bladder Cancer

BeOne Medicines Receives US FDA Accelerated Approval for Beqalzi (Sonrotoclax) to Treat R/R Mantle Cell Lymphoma

Fosun Pharma Obtains Option on AriBio’s Alzheimer’s Disease (AD) Therapy AR1001

AstraZeneca Presents the P-III (CALYPSO) Trial Data on Eneboparatide in Chronic Hypoparathyroidism (HypoPT) at ECE’26

argenx Reports the US FDA Approval of Vyvgart and Vyvgart Hytrulo for Generalized Myasthenia Gravis

BMS’ Sotyktu (Deucravacitinib) Wins EC Approval to Treat Adults with Active Psoriatic Arthritis (PsA)

Beacon Therapeutics Reports P-II (DAWN) Trial Data on Laru-zova in X-Linked Retinitis Pigmentosa (XLRP)

Incyte Reports 24-week P-III (TRuE-AD4) Trial Data on Opzelura (Ruxolitinib) Cream in Moderate Atopic Dermatitis (AD)

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