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 progressionTrial 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…

ByRidhi RastogiApril 23, 2026

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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 2026The device combines three mechanisms for single-pass sampling: a sponge tip absorbs tissue & fluid, a plunger-driven suction aspirates cells & prevents loss, & the…

ByRidhi RastogiApril 23, 2026

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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 positionAs 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, &…

ByRidhi RastogiApril 22, 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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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 statesApproval was based on the P-II (FIREFLY-1) trial assessing Ojemda (QW, PO)…

ByRidhi RastogiApril 22, 2026

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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

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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 T1DApproval 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 resistanceApproval was supported by the P-III trials, incl. Trial 052 (n=513), where pts switched from…

ByRidhi RastogiApril 22, 2026

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Biocon Receives Health Canada Approval for Bosaya and Vevzuo (Biosimilars, Prolia and Xgeva)

Shots:Health Canada has granted NOC to Biocon's Bosaya (60mg/mL, SC, PFS) & Vevzuo (70mg/mL, SC, single-dose vial), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab)Approval was based on extensive data, incl. analytical, nonclinical, & clinical data, showing that both biosimilars matched the reference product in quality, safety & efficacyBosaya & Vevzuo are anti-RANKL monoclonal…

ByRidhi RastogiApril 21, 2026

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Monopar Therapeutics Reports P-III (FoCus) Trial Data on ALXN1840 in Wilson Disease

Shots:Monopar has highlighted P-III (FoCus) trial data assessing ALXN1840 (tiomolibdate choline, TMC; n=77) vs SoC (n=35) in Wilson disease pts with neurologic symptoms at baseline, at AAN’26Trial showed better outcomes with ALXN1840, with lower neurologic worsening (9% vs 25%) & higher improvement (45% vs 32%) vs SoC, plus greater CGI-S (61% vs 17%)…

ByRidhi RastogiApril 21, 2026

Ridhi Rastogi

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

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

Biocon Receives Health Canada Approval for Bosaya and Vevzuo (Biosimilars, Prolia and Xgeva)

Monopar Therapeutics Reports P-III (FoCus) Trial Data on ALXN1840 in Wilson Disease

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