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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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Vanda Pharmaceuticals
NEWS

Vanda Pharmaceuticals Reports the US FDA’s Approval of Bysanti (Milsaperidone) for Acute Bipolar I Disorder & Schizophrenia

Shots: FDA has approved Bysanti, an active metabolite of iloperidone, as a 1L therapy for acute treatment of adults with manic or mixed episodes associated with bipolar I disorder & for schizophrenia, with the latest patent expiring in 2044 & commercial availability expected in Q3’26 In clinical trials, Bysanti showed bioequivalence to Fanapt (iloperidone) across the full…
February 23, 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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Eli lilly
NEWS

Eli Lilly Reports the P-IIIb (TOGETHER-PsO) Trial Data on Taltz + Zepbound for Adults with Psoriasis and Obesity or Overweight

Shots: Eli Lilly has reported P-IIIb (TOGETHER-PsO) trial data assessing Taltz (ixekizumab) + Zepbound (tirzepatide) vs Taltz alone in 274 adults with mod. to sev. plaque psoriasis & obesity/overweight with ≥1 additional weight-related comorbid condition At 36wks., the trial met its 1EP with 27.1% pts reaching PASI 100 & ≥10% weight loss compared to 5.8% pts. Trial…
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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NEWS

Unnatural Products Signs ~$1.8B Licensing Deal with Novartis to Develop Macrocyclic Peptide Therapeutics

Shots: Unnatural Products has entered a research collaboration & licensing agreement with Novartis for an undisclosed cardiovascular program developed using UNP’s AI-enhanced macrocycle platform Under the deal, Novartis will handle IND-enabling studies & subsequent clinical development, manufacturing, & global commercialization of products emerging from the collaboration As per the terms, UNP will receive ~$100M in…
February 19, 2026

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