Novartis’ Rhapsido (Remibrutinib) Receives the US FDA’s Approval for Chronic Spontaneous Urticaria

Shots: The US FDA has approved Rhapsido for the treatment of adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Regulatory filings are also made in the EU, Japan & China, with priority review granted in China Approval was backed by P-III (REMIX-1 & 2) trials in CSU, which showed improved…

ByRidhi RastogiOctober 1, 2025

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Regeneron’s Evkeeza Receives the US FDA’s Approval to Treat Homozygous Familial Hypercholesterolemia in Younger Patients

Shots: The US FDA has approved label expansion to Evkeeza (evinacumab-dgnb) as an adj. to diet, exercise & other lipid-lowering therapies for the treatment of children (1 to <5yrs.) with homozygous familial hypercholesterolemia (HoFH) Approval was supported by efficacy & safety results in 6 children with HoFH (incl. PK data from 4) who participated in…

ByRidhi RastogiSeptember 29, 2025

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Eli Lilly’s Inluriyo (Imlunestrant) Receives the US FDA’s Approval for ESR1-mutated Breast Cancer

Shots: FDA approved Inluriyo (200mg; PO) for treating adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after ≥1L of endocrine therapy; US availability expected in the coming wks. Approval was based on P-III (EMBER-3) trial (N=874: 32% in 1L & 64% in 2L treatment post progression) assessing Inluriyo ± abemaciclib vs fulvestrant/exemestane…

ByRidhi RastogiSeptember 26, 2025

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Ionis’ Tryngolza (Olezarsen) Receives the EC’s Approval for Familial Chylomicronemia Syndrome

Shots: The EC has approved Tryngolza (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome Approval was based on P-III (Balance) trial assessing Tryngolza (Q4W) vs PBO, which showed reduced triglyceride levels at 6mos., sustained through 12mos., with decrease in acute pancreatitis events over 12mos.; data…

ByRidhi RastogiSeptember 23, 2025

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Merck’s Keytruda Qlex Receives the US FDA’s Approval for Subcutaneous Use Across 38 Solid Tumor Indications for Keytruda

Shots: The US FDA has approved Keytruda Qlex (pembrolizumab & berahyaluronidase alfa-pmph) for subcutaneous dosing in adults across 38 approved indications of Keytruda, with US availability expected by late Sep 2025 Approval was based on P-III (3475A-D77) trial assessing Keytruda Qlex (790mg/9600 units, Q6W) + Pt doublet CT vs IV Keytruda (400mg, Q6W) + Pt doublet CT…

ByRidhi RastogiSeptember 22, 2025

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Medtronic’s Altaviva Device Receives the US FDA’s Approval to Treat Urge Urinary Incontinence

Shots: The US FDA has approved the Altaviva device, an implantable tibial neuromodulation therapy to treat urge urinary incontinence Altaviva device is placed under the skin above the fascia & near the ankle in a minimally invasive, sedation & imaging-free procedure to restore bladder–brain communication & improve bladder control by delivering electrical impulses to the tibial…

ByRidhi RastogiSeptember 22, 2025

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Henlius and Organon Receive the EC’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)

Shots: The EC has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference product Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable immunogenicity, efficacy & safety of Bildyos & Bilprevda to reference denosumab In 2022, Henlius…

ByRidhi RastogiSeptember 22, 2025

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The US FDA Grants Accelerated Approval to Stealth BioTherapeutics’ Forzinity for Barth Syndrome

Shots: The US FDA has received accelerated approval from the US FDA for Forzinity (elamipretide HCl)] to improve muscle strength in pts with Barth syndrome (Wt.≥30 kg or 66 lbs) Approval was based on efficacy and safety data from the TAZPOWER trial, which showed improved knee muscle strength Forzinity is a mitochondrial cardiolipin binder. It…

ByDipanshu DixitSeptember 19, 2025

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Deciphera Pharmaceuticals Reports the EC’s Approval of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

Shots: The EC has approved Romvimza (vimseltinib) to treat symptomatic TGCT with physical function deterioration in adults for which surgery may lead to functional impairment or severe morbidity Approval was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs PBO in surgery-ineligible pts without prior anti-CSF1/CSF1R therapy (prior imatinib/nilotinib allowed)…

ByRidhi RastogiSeptember 18, 2025

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Biocon Biologics Receives the FDA’s Approval & Provisional Interchangeability Designation for Aukelso and Bosaya (Biosimilars, Xgeva and Prolia)

Shots: The US FDA has approved & granted provisional interchangeability designation to Aukelso (70mg/mL, SC, single-dose vial) & Bosaya (60mg/mL, SC, PFS), biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) Clinical data showed both biosimilars matched the reference product in quality, safety & efficacy, plus Bosaya was approved with Prolia’s REMS to inform about sev. hypocalcemia…

ByRidhi RastogiSeptember 18, 2025

Novartis’ Rhapsido (Remibrutinib) Receives the US FDA’s Approval for Chronic Spontaneous Urticaria

Regeneron’s Evkeeza Receives the US FDA’s Approval to Treat Homozygous Familial Hypercholesterolemia in Younger Patients

Eli Lilly’s Inluriyo (Imlunestrant) Receives the US FDA’s Approval for ESR1-mutated Breast Cancer

Ionis’ Tryngolza (Olezarsen) Receives the EC’s Approval for Familial Chylomicronemia Syndrome

Merck’s Keytruda Qlex Receives the US FDA’s Approval for Subcutaneous Use Across 38 Solid Tumor Indications for Keytruda

Medtronic’s Altaviva Device Receives the US FDA’s Approval to Treat Urge Urinary Incontinence

Henlius and Organon Receive the EC’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)

The US FDA Grants Accelerated Approval to Stealth BioTherapeutics’ Forzinity for Barth Syndrome

Deciphera Pharmaceuticals Reports the EC’s Approval of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

Biocon Biologics Receives the FDA’s Approval & Provisional Interchangeability Designation for Aukelso and Bosaya (Biosimilars, Xgeva and Prolia)

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