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

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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

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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

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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

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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

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Sanofi Reports the US FDA Approval of Tzield to Delay Onset of Stage 3 Type 1 Diabetes in Children (≥1years)

Shots: The US FDA has approved Sanofi's Tzield (teplizumab-mzwv), under priority review, to delay of the onset of stage 3 T1D in pts (≥1yr.) diagnosed with stage 2 T1D Approval was supported by 1yr. data from the ongoing P-IV (PETITE-T1D) trial assessing the safety & PK of Tzield (IV, QD for 14 consecutive days) in…

ByRidhi RastogiApril 22, 2026

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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

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Philips Receives US FDA 510(k) Clearance for AI-Powered Spectral CT Verida System

Shots: The US FDA has granted 510(k) clearance to Philips for its Spectral CT Verida system, an AI-powered detector-based spectral CT platform for diagnostic imaging Verida integrates always-on spectral imaging with AI-based deep learning reconstruction to enhance image quality, reduce noise, and improve diagnostic precision across radiology, cardiology, and oncology applications The system enables simultaneous…

ByPrince GiriApril 17, 2026

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LEO Pharma Reports the US FDA’s sNDA Acceptance of Anzupgo for Use in Children with Chronic Hand Eczema

Shots: The US FDA has accepted LEO Pharma's sNDA for Anzupgo(delgocitinib) cream for the treatment of pediatric patients (12-17yrs.) with mod. to sev. chronic hand eczema (CHE); regulatory review is ongoing in the EU sNDA was backed by the P-III (DELTA TEEN) trial assessing Anzupgo (20mg/g, BID) vs cream vehicle in pediatric pts with CHE…

ByRidhi RastogiApril 16, 2026

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AOP Health Reports the US FDA Approval Rapiblyk (Landiolol) for Pediatric Patients with Supraventricular Tachycardia

Shots: The US FDA has approved Rapiblyk (landiolol) for use in pediatric pts (from birth to <18 years of age) with supraventricular tachycardia (SVT), expanding its use beyond adults Approval was supported by the LANDI-PED study (n=60), which showed >20% reduction in ventricular rate, demonstrating clinically meaningful heart rate control in this patient subgroup Rapiblyk…

ByRidhi RastogiApril 16, 2026

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)

Sanofi Reports the US FDA Approval of Tzield to Delay Onset of Stage 3 Type 1 Diabetes in Children (≥1years)

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

Philips Receives US FDA 510(k) Clearance for AI-Powered Spectral CT Verida System

LEO Pharma Reports the US FDA’s sNDA Acceptance of Anzupgo for Use in Children with Chronic Hand Eczema

AOP Health Reports the US FDA Approval Rapiblyk (Landiolol) for Pediatric Patients with Supraventricular Tachycardia

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