Immunome Reports the US FDA’s NDA Submission for Varegacestat to Treat Desmoid Tumors in Adults

Shots: The US FDA has received NDA for Immunome’svaregacestat for the treatment of adults with desmoid tumors NDA is supported by the global P-III (RINGSIDE) trial assessing varegacestat (1.2mg, QD) vs PBO until disease progression or death in 156 pts with progressing desmoid tumors; eligible pts could then enter OLE phase, which is ongoing Trial…

ByRidhi RastogiApril 30, 2026

NEWS

The US FDA Grants Priority Review and Breakthrough Therapy Designation to GSK’s Bepirovirsen for Chronic Hepatitis B

Shots: The US FDA has accepted NDA & granted priority review as well as BTD to GSK's bepirovirsen for the treatment of adults with chronic hepatitis B (CHB) NDA & designation were supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline…

ByRidhi RastogiApril 28, 2026

NEWS

AstraZeneca Reports US FDA Approval of Breztri Aerosphere for Asthma

Shots: The US FDA has approved AstraZeneca's Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) for the maintenance treatment of asthma in pts (≥12yrs.); regulatory review is ongoing in the EU, Japan & China Approval was based on the P-III (LOGOS & KALOS) trials evaluating Breztri Aerosphere vs PT009, Symbicort, and PT009 + Symbicort in ~4,300…

ByRidhi RastogiApril 28, 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

Motif Neurotech Receives FDA IDE Approval to Initiate RESONATE Trial of Motif XCS System in Treatment-Resistant Depression

Shots: The US FDA has granted IDE approval to initiate RESONATE Early Feasibility Study of Motif XCS System in pts with treatment-resistant depression, who have received ≥2 medications The trial will assess 12mos. safety of Motif XCS System & procedure post-implantation & measure symptom reduction, quality of life, anxiety, & cognitive function using standard assessments…

ByRidhi RastogiApril 27, 2026

NEWS

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

Regeneron Reports the US FDA Accelerated Approval of Otarmeni (lunsotogene parvec-cwha) in Genetic Hearing Loss

Shots: Otarmeni was approved under CNPV for pediatric & adult pts with sev. to profound and profound sensorineural hearing loss due to biallelic OTOF gene variants, with preserved outer hair cell function & no prior cochlear implant. It will be provided free of charge in the US by Regeneron Approval was based on the P-I/II…

ByRidhi RastogiApril 24, 2026

NEWS

DemeRx Reports the US FDA IND Application Acceptance to Advance DMX-1001 for Alcohol Use Disorder

Shots: The US FDA has accepted IND application of DMX-1001 (oral noribogaine) for the treatment of alcohol use disorder (AUD) DemeRx completed a MAD trial of DMX-1001 in healthy volunteers, demonstrating safety, tolerability, & PK supportive of P-II in AUD. The company plans to initiate a P-II trial of DMX-1001 in AUD in 2027 Noribogaine…

ByRidhi RastogiApril 23, 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

Immunome Reports the US FDA’s NDA Submission for Varegacestat to Treat Desmoid Tumors in Adults

The US FDA Grants Priority Review and Breakthrough Therapy Designation to GSK’s Bepirovirsen for Chronic Hepatitis B

AstraZeneca Reports US FDA Approval of Breztri Aerosphere for Asthma

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

Motif Neurotech Receives FDA IDE Approval to Initiate RESONATE Trial of Motif XCS System in Treatment-Resistant Depression

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

Regeneron Reports the US FDA Accelerated Approval of Otarmeni (lunsotogene parvec-cwha) in Genetic Hearing Loss

DemeRx Reports the US FDA IND Application Acceptance to Advance DMX-1001 for Alcohol Use Disorder

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)

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