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Celltrion
NEWS

Celltrion Secures the US FDA’s Approval for Avtozma IV/SC (Biosimilar, Actemra)

Shots: The US FDA has approved Avtozma IV/SC (biosimilar, Actemra) to treat rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and COVID-19; expected to be commercially available by August 2025 in US Approval was based on the P-III trial of Avtozma (tocilizumab-anoh) vs Actemra (tocilizumab) in…
February 12, 2025

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LIB Therapeutics
NEWS

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…
February 11, 2025

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Abbvie
NEWS

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…
February 10, 2025

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NEWS

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…
February 6, 2025

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Gradalis
NEWS

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…
February 6, 2025

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NEWS

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…
February 5, 2025

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Roche
NEWS

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…
February 5, 2025

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