Johnson & Johnson’s Tremfya (Guselkumab) Receives the EC Approval for Pediatric Plaque Psoriasis (PsO)

Shots: The EC has approved Tremfya (SC) for children (≥6yrs.) with mod. to sev. PsO, who are candidates for systemic therapy Approval was based on P-III (PROTOSTAR) trial in 120 pediatric pts, which met its co-1EPs of PASI 75 (~76% vs 20%) & IGA 0/1 (66% vs 16%) at 16wks., with ~40% vs 4% achieving IGA…

ByRidhi RastogiDecember 22, 2025

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Boehringer Ingelheim Receives the US FDA Approval of Jascayd (Nerandomilast) for Progressive Pulmonary Fibrosis

Shots: The US FDA has approved Jascayd for the treatment of adults with progressive pulmonary fibrosis (PPF) Approval was based on the P-III (FIBRONEER-ILD) trial of Jascayd vs PBO, where Jascayd significantly reduced lung function decline at Wk. 52, with FVC decreases of 86mL (18mg) & 69mL (9mg) vs 152mL with PBO, showing clinically meaningful…

ByRidhi RastogiDecember 22, 2025

NEWS

Cytokinetics Reports the US FDA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The US FDA has approved Cytokinetics’ Myqorzo (5, 10, 15 & 20mg) for the treatment of adults with symptomatic oHCM, available in second half of Jan 2026 through a restricted program via REMS Approval was based on P-III (SEQUOIA-HCM) trial of Myqorzo, showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen…

ByRidhi RastogiDecember 22, 2025

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Johnson & Johnson Receives the US FDA Approval for Rybrevant Faspro to Treat EGFR-Mutated NSCLC

Shots: FDA has approved J&J’s Rybrevant Faspro (amivantamab & hyaluronidase-lpuj, SC) for the treatment of pts with EGFRm NSCLC, covering all approved indications of Rybrevant Approval was backed by P-III (PALOMA-3) trial, evaluating SC vs IV RoA of Rybrevant, in combination with Lazcluze in advanced or metastatic EGFRm NSCLC pts (n=418) whose disease progressed on Tagrisso & Pt-based…

ByRidhi RastogiDecember 18, 2025

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Incyte’s Minjuvi (Tafasitamab) Combination Gains the EC Approval for R/R Follicular Lymphoma (FL)

Shots: The EC has approved Incyte's Minjuvi + rituximab & lenalidomide for the treatment of adults with r/r FL (Grade 1-3a) who received ≥1L of systemic therapy Approval was based on the P-III (inMIND) trial (N=654) assessing Minjuvi combination vs PBO + rituximab & lenalidomide in r/r FL or r/r nodal, splenic or extranodal MZL…

ByRidhi RastogiDecember 18, 2025

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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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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

NEWS

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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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

Johnson & Johnson’s Tremfya (Guselkumab) Receives the EC Approval for Pediatric Plaque Psoriasis (PsO)

Boehringer Ingelheim Receives the US FDA Approval of Jascayd (Nerandomilast) for Progressive Pulmonary Fibrosis

Cytokinetics Reports the US FDA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Johnson & Johnson Receives the US FDA Approval for Rybrevant Faspro to Treat EGFR-Mutated NSCLC

Incyte’s Minjuvi (Tafasitamab) Combination Gains the EC Approval for R/R Follicular Lymphoma (FL)

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

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)

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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