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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

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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Astrazeneca
NEWS

AstraZeneca’s Calquence Regimen Receives the US FDA Approval for Chronic Lymphocytic Leukemia (CLL)

Shots: The US FDA has approved Calquence (acalabrutinib) + venetoclax for the treatment of adults with 1L CLL & small lymphocytic lymphoma; regulatory review is ongoing in other regions Approval was based on the P-III (AMPLIFY) trial assessing the Calquence regimen ± Gazyva vs chemoimmunotherapy in previously untreated CLL pts without del(17p) or TP53 mutation Trial…
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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Takeda
NEWS

Takeda Reports Positive P-III (KEPLER) Results of Entyvio in Pediatric Ulcerative Colitis

Shots: Takeda reported positive data from the global P-III (KEPLER) study evaluating IV ENTYVIO (vedolizumab) in children and adolescents (ages 2–17) with moderate to severe ulcerative colitis (UC) who had inadequate response to conventional therapies and/or TNF antagonists Nearly half (47.3%) of pts achieved the 1EP of clinical remission at Wk. 54, while 34.7% achieved…
February 20, 2026

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NEWS

ViiV Healthcare Reports P-III (LATITUDE) Trial of Cabenuva in Adherence-Challenged HIV Patients

Shots: The P-III (LATITUDE) trial assessed Cabenuva (cabotegravir + rilpivirine) in 453 adults facing adherence challenges, where 306 virally suppressed pts were randomized to Cabenuva (Q4W; n=152) or ART (QD, PO; n=154), with results published in The NEJM At 48wks., Cabenuva reduced the cumulative risk of regimen failure (1EP) to 22.8% vs 41.2%, with fewer virologic failures…
February 19, 2026

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NEWS

ImmunityBio’s Anktiva + BCG Receives EC Conditional Approval for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

Shots: The EC has granted conditional approval to Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS, & with/without papillary tumors in all 30 EEA states, based on P-II/III (QUILT-3.032) study (n=100) Trial showed a 71% CR rate, with a median duration of CR of 26.6mos., plus DoR range was as long as…
February 19, 2026

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