Takeda Reports Topline P-III (LATITUDE) Trials Findings on Zasocitinib in Plaque Psoriasis (PsO)

Shots: Takeda has reported data from 2 global P-III trials (NCT06088043 & NCT06108544) assessing zasocitinib (TAK-279) vs apremilast & PBO in 693 & 1108 adult pts, respectively, with mod. to sev. PsO Trial showed superiority to PBO on co-1EPs (sPGA 0/1 & PASI 75) at Wk. 16, with early PASI 75 responses from Wk. 4, sustained…

ByRidhi RastogiDecember 18, 2025

NEWS

SleepRes’ Kricket PAP Device Receives the US FDA 510(k) Clearance for Obstructive Sleep Apnea

Shots: The US FDA has granted 510(k) clearance to the Kricket PAP device, powered by Kairos Positive Airway Pressure (KPAP), for the treatment of OSA pts (>66lbs) Kricket PAP device uses KPAP tech to dynamically adjust pressure with each breath, synchronizing with pts’ natural respiration to reduce unnecessary pressure, improve comfort & tolerance, & offering…

ByRidhi RastogiDecember 18, 2025

NEWS

Kyverna Therapeutics Reports Topline P-II (KYSA-8) Trial Data of Miv-cel in Stiff Person Syndrome (SPS)

Shots: Kyverna has reported P-II (KYSA-8) trial data assessing a single dose of mivocabtagene autoleucel (miv-cel; KYV-101) in 26 SPS pts having an inadequate response with non-approved treatment options Trial met its 1EP with 46% median improvement in T25FW & 81% pts achieving a clinically meaningful ≥20% gain, plus significant benefits were seen across all…

ByRidhi RastogiDecember 17, 2025

NEWS

GSK Reports the FDA Approval of Exdensur (Depemokimab-ulaa) for Asthma with Eosinophilic Phenotype

Shots: FDA has approved GSK’s Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) with an eosinophilic phenotype following MHRA’s approval for both asthma & CRSwNP; regulatory review is ongoing in EU, Japan & China Approval was based on the P-III trials: SWIFT-1 (n=382) & SWIFT-2 (n=380) assessing Exdensur vs PBO, both in addition to SoC,…

ByRidhi RastogiDecember 17, 2025

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Vanda Pharmaceuticals Seeks FDA Approval for Imsidolimab to Treat Generalized Pustular Psoriasis (GPP)

Shots: The FDA has received Vanda’s BLA for imsidolimab to treat GPP, with a priority review requested that could enable potential approval as early as mid-2026 BLA was supported by global P-III (GEMINI-1 & 2) trials, where GEMINI-1 (n=45) evaluated a single IV dose of imsidolimab (300 or 750mg) vs PBO, & GEMINI-2 re-randomized pts…

ByRidhi RastogiDecember 16, 2025

NEWS

Johnson & Johnson Reports the US FDA Approval of Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The US FDA has approved J&J's Akeega (niraparib & abiraterone acetate tablet) + prednisone to treat adults with BRCA2-mutated mHSPC Approval was backed by the ongoing P-III (AMPLITUDE) trial assessing Akeega + prednisone/prednisolone + ADT vs PBO/abiraterone acetate with prednisone + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC Trial met its…

ByRidhi RastogiDecember 15, 2025

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Zenflow Receives the US FDA Approval for Zenflow Spring Implant and Delivery System for Benign Prostatic Hyperplasia (BPH)

Shots: The US FDA has approved Zenflow Spring Implant & Delivery System, a first-line interventional therapy, for the treatment of BPH-associated symptoms Assessed in the BREEZE study, the system met all 1 & 2EPs, showing a 60% responder rate vs 33% for sham & a 37% IPSS improvement exceeding the 30% success threshold at 1yr.,…

ByRidhi RastogiDecember 12, 2025

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BMS Reports the US FDA’s sBLA Acceptance with Priority Review of Opdivo for Classical Hodgkin Lymphoma (cHL)

Shots: The US FDA has accepted sBLA & granted priority review to BMS' Opdivo (nivolumab) + doxorubicin, vinblastine & dacarbazine (AVD) for the treatment of pts (≥12yrs.) with previously untreated Stage III or IV cHL (PDUFA: Apr 8, 2026) sBLA was supported by the P-III (SWOG S1826/ CA2098UT) trial assessing Opdivo + AVD in above…

ByRidhi RastogiDecember 12, 2025

NEWS

The US FDA Approves Amgen’s Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis

Shots: The US FDA has approved Amgen's Uplizna for the treatment of AChR & MuSK antibody positive adults with generalized myasthenia gravis (gMG) Approval was based on P-III (MINT) trial in 238 adults with gMG (190 AChR+, 48 MuSK+), where pts received 2 Uplizna loading dose followed by 2 doses/year; pts on steroids began tapering…

ByRidhi RastogiDecember 12, 2025

NEWS

GSK Reports the US FDA Approval of Blujepa for Uncomplicated Urogenital Gonorrhoea (uGC)

Shots: The US FDA has approved GSK's Blujepa (gepotidacin) for the treatment of pts (≥12yrs.; ≥45kg) with uGC caused by Neisseria gonorrhoeae who have limited or no alternative options for treatment Approval was backed by P-III (EAGLE-1) trial assessing Blujepa (2 doses × 3000mg; PO) vs ceftriaxone (500mg; IM) + azithromycin (1000mg; PO) in ~600 pts with…

ByRidhi RastogiDecember 12, 2025

Takeda Reports Topline P-III (LATITUDE) Trials Findings on Zasocitinib in Plaque Psoriasis (PsO)

SleepRes’ Kricket PAP Device Receives the US FDA 510(k) Clearance for Obstructive Sleep Apnea

Kyverna Therapeutics Reports Topline P-II (KYSA-8) Trial Data of Miv-cel in Stiff Person Syndrome (SPS)

GSK Reports the FDA Approval of Exdensur (Depemokimab-ulaa) for Asthma with Eosinophilic Phenotype

Vanda Pharmaceuticals Seeks FDA Approval for Imsidolimab to Treat Generalized Pustular Psoriasis (GPP)

Johnson & Johnson Reports the US FDA Approval of Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Zenflow Receives the US FDA Approval for Zenflow Spring Implant and Delivery System for Benign Prostatic Hyperplasia (BPH)

BMS Reports the US FDA’s sBLA Acceptance with Priority Review of Opdivo for Classical Hodgkin Lymphoma (cHL)

The US FDA Approves Amgen’s Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis

GSK Reports the US FDA Approval of Blujepa for Uncomplicated Urogenital Gonorrhoea (uGC)

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