LIB Therapeutics Reports the US FDA’s BLA Acceptance for Lerodalcibep to Reduce LDL-Cholesterol in Cardiovascular Patients

Shots: The US FDA has accepted BLA for lerodalcibep (PCSK9 inhibitor) to lower LDL-C in high-risk or ASCVD pts, HeFH/HoFH pts (≥10 yrs), & primary hyperlipidemia (incl. heterozygous) pts, with no advisory committee meeting planned yet (PDUFA: Dec 12, 2025); EMA’s MAA filing expected in Q2’25 Application was backed by the development program of…

ByRidhi RastogiFebruary 11, 2025

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AliveDx Seeks US FDA’s 510(k) Clearance for MosaiQ AiPlex Multiplex Microarray

Shots: The US FDA has received 510(k) Application for MosaiQ AiPlex Multiplex Microarray to improve & accelerate diagnosis of celiac disease MosaiQ simplifies serological evaluation with syndromic approach by combining IgA & IgG isotypes to detect IgA deficiency & measure anti-tTG as well as anti-DGP (AU/mL) using just 20 μL of sample in single…

ByRidhi RastogiFebruary 10, 2025

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Abbvie Reports the US FDA Approval for Emblaveo to Treat Complicated Intra-Abdominal Infections (cIAI)

Shots: The US FDA has approved Emblaveo (IV) + metronidazole for pts (≥18 yrs) with few or no therapy options for cIAI caused by susceptible gram -ve bacteria, incl. E. coli, K. pneumoniae, K. oxytoca, ECC, C. freundii complex, & S. marcescens; commercially available in Q3’25 Approval was based on prior aztreonam’s efficacy & safety data…

ByRidhi RastogiFebruary 10, 2025

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The US FDA Approves Supernus’ Onapgo (Apomorphine Hydrochloride) for Parkinson’s Disease

Shots: The US FDA has approved Onapgo injection (SPN-830; SC infusion device) to treat motor fluctuations in adults with advanced Parkinson’s disease; commercially available in Q2’25 Approval was based on a 12wk P-III trial assessing Onapgo (n=53) vs PBO (n=51) in Parkinson’s pts (N=107), evaluating 1EP of mean change in total daily OFF time…

ByRidhi RastogiFebruary 7, 2025

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Adicet Bio’s ADI-001 Secures the US FDA’s Fast-Track Designation for Treating Refractory SLE with Extrarenal Involvement

Shots: The US FDA has granted FTD to ADI-001 for treating adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement Adicet Bio is advancing ADI-001 in six autoimmune indications, with patient enrollment ongoing in the P-I LN study. Enrollment in SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM, or myositis), and stiff…

ByRidhi RastogiFebruary 6, 2025

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The US FDA grants RMAT Designation to Gradalis’ Vigil for Advanced Ovarian Cancer

Shots: The US FDA has granted RMAT designation to Vigil (gemogenovatucel-T) as a maintenance therapy for newly diagnosed advanced Stage IIIb/IV HRP ovarian cancer pts with cTMB-H who achieved complete response post-debulking surgery & frontline Pt-based doublet CT Designation was backed by ongoing P-IIb (VITAL) trial assessing Vigil vs PBO showed improved RFS (1EP) in all…

ByRidhi RastogiFebruary 6, 2025

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Gyder Surgical Reports the US FDA’s 510(k) Clearance for Gyder Hip System

Shots: The US FDA has granted 510(k) clearance to the Gyder Hip System for positioning of the acetabular cup during anterior hip arthroplasty following approval from Australia’s TGA Gyder Hip System eliminates the use of metallic pins & pre-operative/intra-operative imaging for landmark registration, offering a less invasive approach than conventional hip navigation System features 1min…

ByRidhi RastogiFebruary 5, 2025

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Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Macular Edema (DME)

Shots: The US FDA has approved Susvimo (port delivery platform with Lucentis) to treat DME Approval was based on P-III (Pagoda) study assessing Susvimo (100 mg/mL, refilled in Q6M) vs Lucentis (0.5mg, intravitreal, Q1M) in DME pts (n=634), where subjects in Susvimo arm received 4 loading doses of Lucentis till 16wks. prior to implantation Study demonstrated sustained vision…

ByRidhi RastogiFebruary 5, 2025

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Novo Nordisk Reports the US FDA’s Approval for Ozempic to Reduce Risk of Kidney Disease Progression & Cardiovascular Death in Type 2 Diabetes & Chronic Kidney Disease (CKD) Adults

Shots: The US FDA has approved Ozempic to reduce the risk of kidney disease worsening & CV death in adults with type 2 diabetes & CKD Approval was based on P-IIIb (FLOW) trial assessing Ozempic (1mg, Q1W, n=1767) vs matching PBO (n=1766) in type 2 diabetes & CKD pts (N=3533) Study met its 1EP of 24% relative…

ByDipanshu DixitFebruary 3, 2025

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Axsome Therapeutics Receives the US FDA Approval for Symbravo (meloxicam and rizatriptan) to Treat Migraine

Shots: The US FDA has approved Symbravo for acute treatment of migraine with/without aura in adults based on P-III (MOMENTUM), P-III (INTERCEPT) & P-III (MOVEMENT) trial; commercially available in ~4mons. MOMENTUM trial assessed Symbravo (single dose) vs PBO/meloxicam/rizatriptan, showing greater pain & symptoms freedom (photophobia, phonophobia & nausea) at 2hrs., sustained through 24-48hrs., 77%…

ByDipanshu DixitJanuary 31, 2025

LIB Therapeutics Reports the US FDA’s BLA Acceptance for Lerodalcibep to Reduce LDL-Cholesterol in Cardiovascular Patients

AliveDx Seeks US FDA’s 510(k) Clearance for MosaiQ AiPlex Multiplex Microarray

Abbvie Reports the US FDA Approval for Emblaveo to Treat Complicated Intra-Abdominal Infections (cIAI)

The US FDA Approves Supernus’ Onapgo (Apomorphine Hydrochloride) for Parkinson’s Disease

Adicet Bio’s ADI-001 Secures the US FDA’s Fast-Track Designation for Treating Refractory SLE with Extrarenal Involvement

The US FDA grants RMAT Designation to Gradalis’ Vigil for Advanced Ovarian Cancer

Gyder Surgical Reports the US FDA’s 510(k) Clearance for Gyder Hip System

Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Macular Edema (DME)

Novo Nordisk Reports the US FDA’s Approval for Ozempic to Reduce Risk of Kidney Disease Progression & Cardiovascular Death in Type 2 Diabetes & Chronic Kidney Disease (CKD) Adults

Axsome Therapeutics Receives the US FDA Approval for Symbravo (meloxicam and rizatriptan) to Treat Migraine

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