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…

April 23, 2026

Crinetics Pharmaceuticals Report the EC Approval of Palsonify for Acromegaly

Shots: The EC has approved Palsonify (paltusotine) for treating adults with acromegaly who are ineligible for or inadequately respond to surgery across all 30 EEA states EC approval was supported by P-III PATHFNDR-1 & PATHFNDR-2 trials evaluating Palsonify in previously treated & medically untreated adults with acromegaly, demonstrating rapid onset, reliable biochemical control & sustained efficacy; it also received ODD in EU Crinetics plans…

April 23, 2026

Novartis’ Rhapsido Receives the EC’s Approval for Chronic Spontaneous Urticaria

Shots: The EC has approved Rhapsido (Remibrutinib) for the treatment of adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment Approval was supported by P-III (REMIX-1 & 2) trials (n=925) in CSU pts, where remibrutinib showed superior improvements in itch, hives & weekly urticaria activity at Wk.12 vs PBO in pts uncontrolled on H1-antihistamines, with a favorable safety profile…

April 23, 2026

Merck Partners with Google Cloud in ~$1B Deal to Build AI-Enabled Enterprise Platform

Shots: Merck partnered with Google Cloud in a multi-year deal worth up to $1B to deploy an AI-driven agentic platform across R&D, manufacturing, commercial, and corporate functions The collaboration will integrate advanced AI tools, incl. Gemini Enterprise, to enhance productivity, digitize data, & support Merck’s global workforce of ~75,000 employees The partnership aims to accelerate…

April 23, 2026

AstraZeneca Reports the P-III (I CAN) Trial Data on Ultomiris for IgA Nephropathy

Shots: AstraZeneca has reported the global P-III (I CAN/ALXN1210-IgAN-320) trial assessing Ultomiris (IV) vs PBO in ~510 adults with IgAN who are at risk of disease progression Trial met its 1EP of reduced proteinuria based on 24-hr. UPCR at 34wks., with effect seen as early as 10wks., while the 1EP of change in eGFR will be…

April 23, 2026

Utepreva Launches Utepreva Endometrial Sampler to Support Early Diagnosis of Endometrial Cancer

Shots: Utepreva has launched the Utepreva Endometrial Sampler, a single-use device designed to improve tissue capture & enable early diagnostic evaluation of endometrial cancer, with availability expected in Oct 2026 The device combines three mechanisms for single-pass sampling: a sponge tip absorbs tissue & fluid, a plunger-driven suction aspirates cells & prevents loss, & the…

April 23, 2026

Amneal Pharmaceuticals to Acquire Kashiv Biosciences for ~$1.1B

Shots: Amneal Pharmaceuticals has entered into a definitive agreement to acquire 100% of Kashiv BioSciences, accelerating its biosimilar pipeline & strengthening US commercial position As per the deal, Amneal will acquire Kashiv for $375M cash & $375M equity at closing, plus up to ~$350M in regulatory milestone payments, potential royalties tied to commercial milestones, &…

April 22, 2026

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…

April 22, 2026

Ipsen’s Ojemda (Tovorafenib) Receives Conditional Approval for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG) in the EU

Shots: The EC has granted conditional approval to Ipsen's Ojemda as a monotx. for the treatment of pts (≥6mos.) with pLGG harbouring a BRAF fusion or rearrangement or BRAF V600 mutation, who have progressed after ≥1 prior systemic therapy, across all 30 EEA states Approval was based on the P-II (FIREFLY-1) trial assessing Ojemda (QW, PO)…

April 22, 2026

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…

April 22, 2026

NEWS

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

Crinetics Pharmaceuticals Report the EC Approval of Palsonify for Acromegaly

Novartis’ Rhapsido Receives the EC’s Approval for Chronic Spontaneous Urticaria

Merck Partners with Google Cloud in ~$1B Deal to Build AI-Enabled Enterprise Platform

AstraZeneca Reports the P-III (I CAN) Trial Data on Ultomiris for IgA Nephropathy

Utepreva Launches Utepreva Endometrial Sampler to Support Early Diagnosis of Endometrial Cancer

Amneal Pharmaceuticals to Acquire Kashiv Biosciences for ~$1.1B

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

Ipsen’s Ojemda (Tovorafenib) Receives Conditional Approval for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG) in the EU

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

Contact US

FOLLOW US