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 Rastogi5 days ago

NEWS

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

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

NEWS

Johnson & Johnson Reports the EC Approval of Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG)

Shots: The EC has approved Imaavy (nipocalimab) as an add-on therapy to treat anti-AChR or anti-MuSK antibody-positive gMG pts (≥12yrs.) Approval was based on the P-III (Vivacity-MG3) trial assessing Imaavy (30mg/kg, IV loading dose then 15mg/kg, Q2W) + SoC (n=77) vs PBO + SoC (n=76) in gMG pts (N=199; 153 were Ab +ve), which showed…

ByRidhi RastogiDecember 2, 2025

NEWS

J&J Accelerates Cancer Innovation with $3.05B Halda Therapeutics Acquisition

Shots: J&J has entered into a definitive agreement to acquire Halda Therapeutics, strengthening its oncology pipeline As per the deal, J&J will acquire Halda for $3.05B in cash, with the deal treated as a business combination & expected to close in the coming months Acquisition will add Halda’s Regulated Induced Proximity TArgeting Chimera (RIPTAC) platform…

ByRidhi RastogiNovember 18, 2025

NEWS

Johnson & Johnson Reports the US FDA’s Approval of Caplyta (Lumateperone) for Major Depressive Disorder

Shots: The US FDA has approved Caplyta as an adjunctive therapy with antidepressants for treating adults with major depressive disorder (MDD). An sNDA for schizophrenia relapse prevention is also submitted Approval was based on 2 P-III (Study 501 & 502) trials assessing Caplyta vs PBO, both in combination with an antidepressant in MDD pts Trial…

ByRidhi RastogiNovember 7, 2025

NEWS

Johnson & Johnson’s Darzalex Faspro Secures the US FDA’s Approval for High-Risk Smouldering Multiple Myeloma (SMM)

Shots: FDA has approved Darzalex Faspro (daratumumab & hyaluronidase-fihj) for high‑risk SMM based on the P-III (AQUILA) study assessing Darzalex Faspro alone vs active monitoring in adults, which met its 1EP of improved PFS by 51%, with 63.1% vs 40.7% pts progression-free at a mFU of 65.2mos. Trial also showed an improved ORR (63.4% vs…

ByRidhi RastogiNovember 7, 2025

NEWS

J&J Reports Long-Term Extension Results from GALAXI-2, GALAXI-3, and GRAVITI Trials of Tremfya (Guselkumab) for Crohn’s Disease

Shots: J&J has reported 96wk. P-III trial data in mod. to sev. Crohn’s Disease incl. GRAVITI (SC induction: 400mg Q4W; maintenance: 200mg at Wk. 12 then Q4W or 100mg at Wk. 16 then Q8W) vs PBO, & GALAXI 2 & 3 (IV induction: 200mg Q4W; SC maintenance) vs Stelara In GRAVITI, 92% (100mg) & 93.4%…

ByRidhi RastogiOctober 29, 2025

NEWS

Johnson & Johnson Reports the US FDA’s sNDA Acceptance & Priority Review of Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The US FDA has accepted sNDA & granted priority review to Akeega (niraparib & abiraterone acetate tablet) + prednisone to treat adults with BRCA-mutated mHSPC sNDA was backed by 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…

ByRidhi RastogiOctober 17, 2025

NEWS

Johnson & Johnson Reports P-III (ASTRO) Trial Data of SC Tremfya (Guselkumab) for Ulcerative Colitis (UC)

Shots: J&J has reported P-III (ASTRO) trial data assessing Tremfya SC induction (400mg at Wks. 0, 4 & 8) followed by maintenance dose of either Tremfya 100mg (SC, Q8W) or 200mg (SC, Q4W) vs PBO in adults (n=418) with mod. to sev. active UC At Wk. 48, trial showed improved clinical remission rates of 36.7%…

ByRidhi RastogiOctober 9, 2025

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

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

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

Johnson & Johnson Reports the EC Approval of Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG)

J&J Accelerates Cancer Innovation with $3.05B Halda Therapeutics Acquisition

Johnson & Johnson Reports the US FDA’s Approval of Caplyta (Lumateperone) for Major Depressive Disorder

Johnson & Johnson’s Darzalex Faspro Secures the US FDA’s Approval for High-Risk Smouldering Multiple Myeloma (SMM)

J&J Reports Long-Term Extension Results from GALAXI-2, GALAXI-3, and GRAVITI Trials of Tremfya (Guselkumab) for Crohn’s Disease

Johnson & Johnson Reports the US FDA’s sNDA Acceptance & Priority Review of Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Johnson & Johnson Reports P-III (ASTRO) Trial Data of SC Tremfya (Guselkumab) for Ulcerative Colitis (UC)

Contact US

OUR INFORMATION

FOLLOW US