Johnson & Johnson Reports the P-III (Study 451) Trial Data on Caplyta in Bipolar Mania

Shots: J&J has reported the P-III (Study 451) trial data, assessing Caplyta (lumateperone; 42mg, QD) vs PBO for the treatment of manic episodes with or without mixed features in adults with bipolar I disorder, at Psych Congress 2026 Trial met its 1EP, showing a 4.8-point greater reduction in YMRS total score at Wk. 3, with…

ByRidhi Rastogi4 days ago

NEWS

Johnson & Johnson Reports the EC Approval of Icotyde (Icotrokinra) to Treat Plaque Psoriasis (PsO)

Shots: The EC has approved Icotyde for the treatment of pts (≥12yrs., ≥40kg) with mod. to sev. plaque PsO who are candidates for systemic therapy Approval was backed by P-III (ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 & 2) trials, where Icotyde met all 1EP across all 4 trials (n=2,500). In the head-to-head studies, ~70% pts achieved IGA 0/1 & 55%…

ByRidhi Rastogi4 days ago

NEWS

Johnson & Johnson Secures CE Mark Approval for ACUVUE OASYS MAX Reusable Contact Lenses

Shots: J&J has received CE Mark approval for Acuvue Oasys MAX 2-Week, a reusable contact lens featuring MAX technologies designed for superior comfort & visual clarity through day 14 Key features incl. OptiBlue Light Filter, which filters ≥60% blue-violet light, TearStable Tech that locks in moisture, & Class 1 UV blocking, when combined help to…

ByRidhi RastogiSeptember 11, 2026

NEWS

J&J Reports US FDA Approval of Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

Shots: The US FDA has approved Imaavy (nipocalimab-aahu) for the treatment of wAIHA in pts (≥12yrs.) currently or previously treated with corticosteroids Approval was based on the P-II/III (ENERGY) trial, which assessed 2 different dose schedules of Imaavy vs PBO in 115 adults living with wAIHA for 24wks. followed by an OLE period, where pts…

ByRidhi RastogiAugust 25, 2026

NEWS

Johnson & Johnson Receives EC Approval for Tecvayli Combination for R/R Multiple Myeloma

Shots: The EMA has approved a label extension of Tecvayli (teclistamab) + Darzalex (daratumumab) for the treatment of adults with r/r multiple myeloma (RRMM) who have received ≥1 prior therapy Approval was supported by the P-III (MajesTEC-3) trial evaluating Tecvayli + Darzalex (SC) vs investigator’s choice of Darzalex (SC) & dexamethasone with either pomalidomide or bortezomib in…

ByRidhi RastogiAugust 24, 2026

NEWS

J&J Partners with Sail Biomedicines to Advance In Vivo CAR-T Therapies

Shots: J&J has entered strategic agreements & collaboration with Sail to advance its lead immune-mediated disease program & in vivo CAR-T platform, with the potential to expand the platform across additional therapeutic targets As per the deal, Sail will receive initial payments of $785M, incl. a $465M equity investment, with additional contingent payments of ~$140M…

ByRidhi RastogiJuly 30, 2026

NEWS

J&J Reports the P-II/III (ENERGY) Trial Data on Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

Shots: The P-II/III (ENERGY) trial assessed 2 different dose schedules of J&J's Imaavy vs PBO in 115 adults living with wAIHA for 24wks. followed by an OLE period, where pts received Imaavy for 144wks. with a follow-up of 6wks. after the last assessment In the 30mg/kg group, Imaavy showed mean increase of 1g/dL in Hgb…

ByRidhi RastogiJune 11, 2026

NEWS

Johnson & Johnson to Acquire Firefly Bio for $1B

Shots: J&J has entered into a definitive agreement to acquire Firefly Bio, incl. its Firelink degrader antibody conjugate (DAC) platform, expanding its oncology pipeline As per the deal, J&J will acquire Firefly Bio for $1B in cash, with closing expected later this year The Firelink DAC platform is a targeted protein degradation tech that selectively…

ByRidhi RastogiJune 9, 2026

NEWS

J&J Receives the US FDA Priority Review for Imaavy to Treat Warm Autoimmune Hemolytic Anemia (wAIHA)

Shots: The US FDA has accepted sBLA & granted priority review to J&J's Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) sBLA was supported by P-II/III (ENERGY) trial assessing the efficacy & safety of Imaavy vs PBO in adults with wAIHA, followed by an OLE period Trial showed that pts treated with Imaavy…

ByRidhi RastogiApril 28, 2026

NEWS

Johnson & Johnson Reports Clinical Findings on Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG) at AAN 2026

Shots: J&J has reported data from the P-III (Vivacity-MG3) trial assessing Imaavy + SoC (n=77) vs PBO + SoC (n=76) in gMG pts (N=199; 153 were Ab +ve), plus from an ongoing OLE trial. Also, enrolment is ongoing in the EPIC trial of Imaavy against efgartigimod The 24wk. Post-hoc analysis data showed adults receiving Imaavy…

ByRidhi RastogiApril 24, 2026

Johnson & Johnson Reports the P-III (Study 451) Trial Data on Caplyta in Bipolar Mania

Johnson & Johnson Reports the EC Approval of Icotyde (Icotrokinra) to Treat Plaque Psoriasis (PsO)

Johnson & Johnson Secures CE Mark Approval for ACUVUE OASYS MAX Reusable Contact Lenses

J&J Reports US FDA Approval of Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

Johnson & Johnson Receives EC Approval for Tecvayli Combination for R/R Multiple Myeloma

J&J Partners with Sail Biomedicines to Advance In Vivo CAR-T Therapies

J&J Reports the P-II/III (ENERGY) Trial Data on Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

Johnson & Johnson to Acquire Firefly Bio for $1B

J&J Receives the US FDA Priority Review for Imaavy to Treat Warm Autoimmune Hemolytic Anemia (wAIHA)

Johnson & Johnson Reports Clinical Findings on Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG) at AAN 2026

Contact US

FOLLOW US