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NEWS

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…
February 24, 2026

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NEWS

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…
February 23, 2026

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NEWS

Dr. Reddy’s Reports the US FDA’s BLA Acceptance for DRL_AB (Biosimilar, Orencia)

Shots: The US FDA has accepted 351 (k) BLA for DRL_AB (IV), a proposed interchangeable biosimilar to Orencia (abatacept) Upon approval, DRL_AB will be indicated for adults with mod. to sev. active rheumatoid arthritis, adults with active psoriatic arthritis, & pts (≥6yrs.) with mod. to sev. active polyarticular juvenile idiopathic arthritis BLA was supported by extensive…
February 23, 2026

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Roche
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The US FDA Accepts Roche’s Giredestrant NDA for ESR1-Mutated, ER-Positive Advanced Breast Cancer

Shots: The US FDA has accepted Roche’s NDA for giredestrant in combination with everolimus to treat adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on prior endocrine-based therapy NDA acceptance is based on P-III (evERA) study data showing giredestrant + everolimus reduced the risk of disease progression or…
February 20, 2026

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NEWS

NexEos Bio Receives US FDA IND Clearance to Advance NTX-1024 into P-II/III Study for Vernal Keratoconjunctivitis

Shots: The US FDA has cleared NexEos Bio’s IND application to initiate a P-II/III clinical study of NTX-1024 ophthalmic solution for the treatment of vernal keratoconjunctivitis (VKC) The P-II/III study will evaluate the safety and efficacy of NTX-1024 in VKC, following positive results from an open-label investigator-initiated study showing improvements in symptoms and ocular inflammation…
February 20, 2026

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NEWS

Accord BioPharma’s Filkri (Biosimilar, Neupogen) Receives the US FDA Approval

Shots: FDA has approved Filkri, a biosimilar to Neupogen (filgrastim), for pts receiving myelosuppressive CT, those with AML receiving induction or consolidation CT, cancer pts undergoing bone marrow transplant, pts with sev. chronic neutropenia, & pts exposed to myelosuppressive radiation Approval was supported by 2 studies in healthy adults, with PK/PD assessed in one, &…
February 18, 2026

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