Ascendis’ Yuviwel (Navepegritide) Receives the US FDA Accelerated Approval for Achondroplasia

Shots: FDA granted accelerated approval to Yuviwel (navepegritide, QW) to increase linear growth in children (≥2yrs.) with achondroplasia & open epiphyses; commercially available by Q2’26 Approval was based on extensive clinical data, incl. 3 PBO-controlled trials plus up to 3yrs. of OLE data, with the pivotal ApproaCH results published in JAMA Pediatrics Continued approval may…

ByRidhi Rastogi11 hours ago

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Ionis’ Olezarsen sNDA Secures the US FDA Priority Review for Severe Hypertriglyceridemia

Shots: The US FDA has accepted sNDA & granted priority review to olezarsen for the treatment of severe hypertriglyceridemia (sHTG), with a PDUFA action date of Jun 30, 2026 sNDA was backed by the P-III (CORE: n=617 & CORE2: n=446) trials assessing olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in sHTG adults…

ByRidhi Rastogi3 days ago

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The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for 1L HER2-Mutant NSCLC

Shots: The US FDA has granted accelerated approval to Hernexeos (zongertinib) for the 1L treatment of pts with advanced NSCLC harboring HER2 (ERBB2) tyrosine kinase domain activating mutations Approval was based on the data from a treatment-naïve cohort (N=72) of the P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 76% (11%…

ByRidhi Rastogi4 days ago

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Merck Animal Health’s Numelvi Secures the FDA Approval for Control of Pruritus Associated with Allergic Dermatitis in Dogs

Shots: The US FDA has approved Numelvi (Atinvicitinib) for the control of pruritus associated with allergic dermatitis in dogs (≥6mos.), with availability expected in spring 2026 Numelvi is a second-generation JAK inhibitor supplied in easy-to-dispense bottles and designed for convenient storage under standard conditions. Numelvi is ≥10-fold more selective for JAK1 over JAK2, JAK3 &…

ByRidhi Rastogi4 days ago

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Pfizer’s Braftovi Regimen Receives US FDA Full Approval for Metastatic Colorectal Cancer

Shots: The US FDA has granted full approval to Braftovi + cetuximab & fluorouracil-based CT for the treatment of adults with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation Approval was backed by the P-III (BREAKWATER) study assessing Braftovi (300mg, PO, QD) in pts, randomized to Braftovi + cetuximab (n=158), Braftovi + cetuximab + mFOLFOX6 (n=236),…

ByRidhi RastogiFebruary 25, 2026

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The US FDA Approves Regeneron and Sanofi’s Dupixent for Allergic Fungal Rhinosinusitis (AFRS)

Shots: FDA approved Dupixent for pts (≥6yrs.) with AFRS & have a history of sino-nasal surgery, based on the P-III (LIBERTY-AFRS-AIMS) trial, assessing age & weight-based Dupixent dosing (200 or 300mg; Q2W or Q4W; n=33) vs PBO (n=29) in 62 pts Trial met its 1EP with improved sinus opacification by 50% vs 10% at Wk. 52,…

ByRidhi RastogiFebruary 25, 2026

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J&J Reports the FDA’s sBLA Submission for Imaavy to Treat Warm Autoimmune Hemolytic Anemia

Shots: The US FDA has received an sBLA of 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 achieved stringent 1EP of a durable hemoglobin response & showed…

ByRidhi RastogiFebruary 25, 2026

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Sebela Pharmaceuticals Licenses Miudella to Organon in ~$532M Deal

Shots: Sebela Pharmaceuticals has entered into an agreement granting Organon exclusive global rights to Miudella, a hormone-free copper intrauterine device (IUD) contraceptive As per the deal, Sebela will receive $27.5M at closing & ~$505M in sales-based milestone payments, with tiered net sales-based double-digit royalties Miudella was approved by the US FDA in Feb 2025, for…

ByRidhi RastogiFebruary 24, 2026

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Immedica Pharma Receives the US FDA Accelerated Approval for Loargys to Treat Hyperargininemia in Patients with ARG1-D

Shots: The US FDA has granted accelerated approval to Loargys (pegzilarginase-nbln) for the treatment of hyperargininemia in pts (≥2yrs.) with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction, with commercial availability expected in Apr 2026 Approval was based on the P-III (PEACE) trial assessing Loargys vs PBO, which showed reduced plasma arginine from…

ByRidhi RastogiFebruary 24, 2026

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Gilead Sciences to Acquire Arcellx for $7.8B

Shots: Gilead Sciences has entered into a definitive agreement to acquire Arcellx, incl. anito-cel from their 2022 collaboration & Arcellx’s D-Domain CAR technology platform, for the implied equity value of $7.8B As per the deal, Gilead, which owns ~11.5% of Arcellx, will launch a tender offer for $115/share, plus a non-transferable CVR of $5/CVR tied…

ByRidhi RastogiFebruary 23, 2026

Ascendis’ Yuviwel (Navepegritide) Receives the US FDA Accelerated Approval for Achondroplasia

Ionis’ Olezarsen sNDA Secures the US FDA Priority Review for Severe Hypertriglyceridemia

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for 1L HER2-Mutant NSCLC

Merck Animal Health’s Numelvi Secures the FDA Approval for Control of Pruritus Associated with Allergic Dermatitis in Dogs

Pfizer’s Braftovi Regimen Receives US FDA Full Approval for Metastatic Colorectal Cancer

The US FDA Approves Regeneron and Sanofi’s Dupixent for Allergic Fungal Rhinosinusitis (AFRS)

J&J Reports the FDA’s sBLA Submission for Imaavy to Treat Warm Autoimmune Hemolytic Anemia

Sebela Pharmaceuticals Licenses Miudella to Organon in ~$532M Deal

Immedica Pharma Receives the US FDA Accelerated Approval for Loargys to Treat Hyperargininemia in Patients with ARG1-D

Gilead Sciences to Acquire Arcellx for $7.8B

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