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Shionogi Secures US FDA Approval of Xocova for PEP COVID-19 Prevention

Shots:  The US FDA has approved Xocova (ensitrelvir) for post-exposure prophylaxis (PEP) of COVID-19 in adults and adolescents (age≥12 yrs) following exposure to a person with COVID-19  Approval was based on a global P-III (SCORPIO-PEP) trial in 2,387 participants aged ≥12 yrs exposed to a household member with symptomatic COVID-19. The primary analysis included 2,041 SARS-CoV-2-negative participants who received Xocova (n=1,030; 375 mg on…
May 29, 2026

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Cogent Biosciences Receives the US FDA Priority Review for Bezuclastinib Combination to Treat Gastrointestinal Stromal Tumors (GIST)

Shots: The US FDA has accepted NDA & granted priority review to Cogent's bezuclastinib + sunitinib for the treatment of pts with GIST who were treated with imatinib, with no advisory committee meeting planned yet (PDUFA: Nov 30, 2026) NDA was supported by the P-III (PEAK) trial data assessing bezuclastinib + sunitinib vs sunitinib monotx.…
May 29, 2026

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Haisco Pharmaceutical Secures US FDA Approval of Cypsedo for Adult General Anesthesia Prior to Surgery 

Shots:  The US FDA has approved Cypsedo (Cipepofol) to induce general anesthesia in adults undergoing surgery  Cipepofol (Chinese trade name: Sishuning) is China's first domestically developed Class 1 innovative intravenous anesthetic with global IP rights. It is approved in China for procedural sedation, induction and maintenance of general anesthesia, and ICU sedation during mechanical ventilation  In Dec 2020, Cipepofol, approved…
May 29, 2026

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Astrazeneca
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AstraZeneca Receives the US FDA Approval for Imfinzi Regimen to Treat High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Shots: The US FDA has approved AZ's Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction & maintenance therapy for the treatment of adults with BCG-naïve, high-risk NMIBC; regulatory review is ongoing in the EU & Japan Approval was based on the P-III (POTOMAC) trial of 1018 high-risk, BCG-naïve NMIBC pts post-TURBT, randomized to Imfinzi…
May 29, 2026

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Ironwood Pharmaceuticals Reports the US FDA Approval of Linzess to Treat Pediatric Patients (≥2yrs.) with Functional Constipation

Shots: The US FDA has approved label expansion of Linzess (linaclotide) in pts (≥2yrs.) for the treatment of functional constipation (FC) Approval was supported by data from a 12wk. P-III trial assessing Linzess in pediatric pts (2-5yrs.) with FC, where Linzess (72mcg) showed improvement in spontaneous bowel movement frequency vs PBO Linzess contains linaclotide, a…
May 28, 2026

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Abbvie
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AbbVie Reports the US FDA Approval for Decnupaz to Treat Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Shots: The US FDA has approved AbbVie's Decnupaz (pivekimab sunirine-pvzy) for the treatment of adults with BPDCN Approval was supported by the global P-I/II (CADENZA) trial in 84 pts with CD123+ hematologic malignancies, incl. BPDCN, where pts received Decnupaz in both frontline (n=33) & relapsed/refractory (R/R) settings (n=51) without active CNS disease  Trial reported a 69.7% composite…
May 28, 2026

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TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Alzheimer’s Disease Test

Shots: The US FDA has granted BDD to the TOBY Test for diagnosing Alzheimer’s disease in adults (≥50yrs.) with signs and symptoms of cognitive impairment undergoing evaluation for Alzheimer’s disease The TOBY Test is a non-invasive urine-based diagnostic designed to aid Alzheimer’s disease diagnosis by analyzing urinary volatile organic compound patterns using mass spectrometry and…
May 27, 2026

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Sobi Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at EAS 2026

Shots: Sobi has reported pooled subgroup analysis (n=455) from P-III (CORE: n=617 & CORE2: n=446) trials assessing Tryngolza (olezarsen; 50 or 80mg, SC, Q4W) vs PBO in adults with severe hypertriglyceridemia (sHTG) & triglyceride (TG) levels ≥500 mg/dL Trial showed PBO-adjusted TG reductions of 66% (80mg) & 59% (50mg) at 6mos. in pts with TGs…
May 27, 2026

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