AstraZeneca Reports FDA Approval of Saphnelo for Systemic Lupus Erythematosus (SLE)

Shots: The US FDA has approved AstraZeneca’s Saphnelo pen (anifrolumab; 120mg, SC, QW, autoinjector) for the treatment of adults with SLE in combination with SoC Approval was based on the P-III (TULIP-SC) trial assessing Saphnelo pen vs PBO in 367 pts (18-70yrs.) with mod. to sev. SLE while receiving SoC, which showed Saphnelo reduced disease activity (1EP); full…

ByRidhi RastogiApril 27, 2026

NEWS

Sanofi Reports the CHMP Positive Opinion for Cenrifki (Tolebrutinib) to Treat Non-Relapsing SPMS

Shots: The CHMP has recommended Sanofi's Cenrifki for the treatment of SPMS without relapses in the last 2yrs.; regulatory submissions are ongoing in other regions Opinion was backed by P-III (HERCULES) trial in non-relapsing SPMS & supporting data from P-III (GEMINI 1 & 2) studies in relapsing multiple sclerosis, with HERCULES demonstrating delayed onset of…

ByRidhi RastogiApril 27, 2026

NEWS

Novartis’ Itvisma Receives the CHMP Positive Opinion for Spinal Muscular Atrophy

Shots: The CHMP has recommended Novartis' Itvisma (onasemnogene abeparvovec) for the treatment of pts (≥2yrs.) living with 5q spinal muscular atrophy (SMA) harboring a confirmed bi-allelic mutation in the SMN1 gene Opinion was based on the P-III (STEER) trial & P-IIIb (STRENGTH) study, where STEER showed a 2.39-point improvement in the HFMSE with effects sustained…

ByRidhi RastogiApril 27, 2026

NEWS

Arrowhead Pharmaceuticals Receives the CHMP’s Positive Opinion for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

Shots: The CHMP has recommended Arrowhead's Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with FCS; EC’s decision is expected in Q2’26 Opinion was supported by the P-III (PALISADE) trial assessing Redemplo (25mg & 50mg, SC, Q3M) vs PBO in 75 adults with genetically confirmed/clinically diagnosed FCS. Pts could join a…

ByRidhi RastogiApril 24, 2026

NEWS

Mabwell Initiates P-III Trial for 9MW2821 in TNBC

Shots: Mabwell has initiated a P-III trial of 9MW2821 in triple-negative breast cancer (TNBC), marking the fourth pivotal study for 9MW2821 The trial will assess the efficacy of 9MW2821 vs the investigator’s choice chemotherapy in locally advanced or metastatic TNBC pts previously treated with taxane-based CT ± immunotherapy & a topoisomerase inhibitor-based ADC 9MW2821, a…

ByRidhi RastogiApril 24, 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

NEWS

Regeneron and Sanofi Report the US FDA Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Shots: FDA has approved Dupixent to treat CSU pts (age 2-11yrs.), who were symptomatic despite H1 antihistamine treatment based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program, & P-III (CUPIDKids) trial Study A & C assessed Dupixent + SoC antihistamines (loading dose then 300mg Q2W; pts weighing <60kg received 200mg) vs PBO…

ByRidhi RastogiApril 23, 2026

NEWS

Regeneron Reports P-III (NIMBLE) Trial Data on Cemdisiran for Generalized Myasthenia Gravis (gMG)

Shots: The Regeneron's P-III (NIMBLE) trial enrolled adults with symptomatic gMG & anti-AChR antibodies, randomizing them to either cemdisiran monotx. (600mg, SC, Q12W), pozelimab monotx. (200 mg, Q4W), cemdi-poze (200mg each, Q4W), or PBO (Q4W) cemdisiran (Q12W; n=64) vs PBO (n=59) improved gMG within 2wks., sustained to Wk. 24; MG-ADL (1EP) improved by 4.5 vs…

ByRidhi RastogiApril 22, 2026

NEWS

Genentech Reports the P-III (METEOROID) Trial Data on Enspryng (Satralizumab) to Treat MOGAD

Shots: The Genentech's P-III (METEOROID) trial data assessed Enspryng (60, 120 or 180mg based on body weight; SC) vs PBO, administered at 0, 2 & 4wks., then Q4W thereafter in pts (≥12yrs.) with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) Trial met its 1EP with 87% vs 67% relapse-free pts at 48wks., & response onset as…

ByRidhi RastogiApril 22, 2026

NEWS

Merck Reports the US FDA Approval of Idvynso for Virologically Suppressed HIV-1 Infection

Shots: The US FDA approved MSD's Idvynso (100mg doravirine/0.25mg islatravir; QD, PO) to treat HIV-1 in virologically suppressed adults (HIV-1 RNA <50 copies/mL) as a switch option for those on stable regimens with no prior treatment failure or doravirine resistance Approval was supported by the P-III trials, incl. Trial 052 (n=513), where pts switched from…

ByRidhi RastogiApril 22, 2026

AstraZeneca Reports FDA Approval of Saphnelo for Systemic Lupus Erythematosus (SLE)

Sanofi Reports the CHMP Positive Opinion for Cenrifki (Tolebrutinib) to Treat Non-Relapsing SPMS

Novartis’ Itvisma Receives the CHMP Positive Opinion for Spinal Muscular Atrophy

Arrowhead Pharmaceuticals Receives the CHMP’s Positive Opinion for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

Mabwell Initiates P-III Trial for 9MW2821 in TNBC

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

Regeneron and Sanofi Report the US FDA Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Regeneron Reports P-III (NIMBLE) Trial Data on Cemdisiran for Generalized Myasthenia Gravis (gMG)

Genentech Reports the P-III (METEOROID) Trial Data on Enspryng (Satralizumab) to Treat MOGAD

Merck Reports the US FDA Approval of Idvynso for Virologically Suppressed HIV-1 Infection

Contact US

FOLLOW US