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INSIGHTS+

EMA Marketing Authorization of New Drugs in May 2026    

Shots:  The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in May 2026 across pulmonology, oncology, rare diseases, immunology, aesthetics, and endocrinology, involving companies including Boehringer Ingelheim, Novartis, AstraZeneca, AbbVie, Pharming, and Amgen.  CHMP positive opinions included Jascayd for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, Vijoice for PIK3CA-related overgrowth spectrum (PROS) disorders, Camizestrant (Etcamah) for ESR1-mutated advanced breast cancer,…
3 days ago

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VIEWPOINTS

IL-33 Breakthrough in COPD: Caterina Brindicci and Frank Sciurba on Tozorakimab’s Phase III Success 

Shots:  Tozorakimab demonstrated a potential first-in-class advantage in COPD, becoming the first IL-33 biologic to achieve positive outcomes across three pivotal Phase III trials (OBERON, TITANIA, and MIRANDA), highlighting the clinical relevance of targeting both reduced and oxidized forms of IL-33 to reduce exacerbations in a broad patient population.  The LUNA Phase III programme enrolled the most comprehensive…
June 15, 2026

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Astrazeneca
NEWS

AstraZeneca Reports FDA’s sBLA Acceptance Under Priority Review for Ultomiristo Treat IgA Nephropathy

Shots: The US FDA has accepted sBLA & granted priority review to AZ's Ultomiris (ravulizumab) for the treatment of adults with immunoglobulin A nephropathy (IgAN), with a PDUFA action date anticipated in Q4’26 sBLA was supported by the interim analysis data from the global P-III (I CAN/ALXN1210-IgAN-320) trial assessing Ultomiris (IV) vs PBO in ~510 adults with…
June 15, 2026

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Astrazeneca
NEWS

AstraZeneca’s Truqap Combination Receives the US FDA Approval for PTEN-Deficient mAPMN/S Prostate Cancer

Shots: FDA has approved AZ's Truqap + abiraterone & ADT, along with its companion diagnostic test for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer; regulatory review is ongoing in the EU Approval was based on the global P-III (CAPItello-281) trial assessing Truqap + abiraterone & ADT vs PBO + abiraterone…
June 15, 2026

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INSIGHTS+

The US FDA New Drug Approvals in May 2026 

Shots:  The US FDA approved eight therapies in May 2026 across oncology, cardiovascular disease, infectious diseases, anesthesia, and antimicrobial resistance, reflecting continued regulatory momentum in addressing both rare and prevalent diseases.   Key approvals included Veppanu (breast cancer), Beqalzi (mantle cell lymphoma), Baxfendy (hypertension), Hepcludex (HDV infection), Decnupaz (BPDCN), Zaynich (cUTI), Cypsedo (general anesthesia), and Xocova (COVID-19 PEP).   Overall, May 2026 underscored the FDA’s commitment to advancing innovative medicines, precision therapies, and expanded patient access,…
June 9, 2026

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Astrazeneca
NEWS

AstraZeneca Highlights P-III (SERENA-6) Trial Data on Camizestrant Combination for ESR1 Mutated Advanced Breast Cancer at ASCO’26

Shots: AZ's trial assessed camizestrant (n=157) vs AI (anastrozole/letrozole; n=158), both in combination with CDK4/6 inhibitor in 315 pts with LA/M HR+/HER2- advanced breast cancer harboring ESR1 mutation; filings supported by the trial are under review in the US, EU & Japan Trial showed 24mos. PFS rate of 34.9% vs 14.2% (mPFS: 16.8 vs…
June 3, 2026

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VIEWPOINTS

Advancing HES Care with AstraZeneca’s FASENRA: Insights from James Teague & Princess U. Ogbogu

Shots:  Could a targeted biologic therapy help address the longstanding unmet needs in hypereosinophilic syndrome (HES)? AstraZeneca’s FASENRA has now received US approval for HES, introducing a once-monthly treatment option for patients living with this rare and often underdiagnosed eosinophilic disorder  Results from the Phase III NATRON trial showed that FASENRA reduced the risk of first HES flare by 65% vs placebo,…
June 1, 2026

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Astrazeneca
NEWS

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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