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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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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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MAGAZINE

PharmaShots Magazine-May-2026 Edition

Shots: PharmaShots’ May Edition explores how AI is transforming commercial strategies across the healthcare ecosystem by enabling predictive analytics, personalized engagement, dynamic launch planning, and real-time omnichannel optimization while balancing compliance and measurable ROI. The magazine highlights key industry movements shaping global biopharma, including AI-driven drug discovery collaborations, strategic M&A activity, advancements in cell and…
May 14, 2026

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INSIGHTS+

The US FDA New Drug Approvals in April 2026 

Shots:  Approval activity continued strongly into April 2026, with the US FDA authorizing two significant therapies across metabolic disease and infectious disease, reinforcing the agency’s focus on chronic disease management, long-term treatment innovation, and broader patient access.  Two notable therapies achieved regulatory clearance: Eli Lilly’s Foundayo for weight loss in obese or overweight adults with weight-related conditions,…
May 12, 2026

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NEWS

CareDx to Acquire Naveris for ~$260M

Shots: CareDx has entered into a definitive agreement to acquire Naveris, extending CareDx’s Precision Medicine Testing Services strategy into specialty oncology As per the deal, CareDx will acquire Naveris for $160M upfront & up to $100M in revenue milestones; closing is expected in Q3’26 Naveris’ liquid biopsy platform uses TTMV DNA to detect viral DNA…
April 29, 2026

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NEWS

X4 Pharmaceuticals’ Xolremdi Receives the EC’s Approval for WHIM Syndrome 

Shots:  The EC has approved Xolremdi (Mavorixafor), under exceptional circumstances, for the treatment of WHIM syndrome  Approval was supported by the global pivotal P-III (4WHIM) trial, PBO-controlled 52-wk study evaluating mavorixafor’s efficacy & safety in pts ≥12 yrs with WHIM syndrome  Xolremdi (PO, QD), a CXCR4 antagonist, is used in pts ≥12 yrs with WHIM syndrome to increase circulating mature neutrophils & lymphocytes  Ref: X4…
April 27, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in March 2026    

Shots:  The European Medicines Agency advanced multiple new drug approvals and late-stage recommendations in March 2026, spanning oncology, immunology, rare diseases, and women’s health, with key decisions involving Pharming, Immedica, Amgen, Gedeon Richter, UCB, and Sanofi  The Committee for Medicinal Products for Human Use issued positive opinions for innovative therapies, including leniolisib (Joenja) for APDS, lurbinectedin + atezolizumab…
April 21, 2026

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INSIGHTS+

The US FDA New Drug Approvals in March 2026 

Shots:  Approval momentum accelerated in late March 2026, with the US FDA clearing five new therapies across hepatology, dermatology, rare genetic disorders, oncology, and endocrinology; highlighting both therapeutic breadth and meaningful clinical impact.  Five notable therapies crossed the regulatory finish line: GSK’s Lynavoy for cholestatic pruritus in primary biliary cholangitis, Johnson & Johnson’s Icotyde for moderate-to-severe plaque psoriasis, Denali…
April 14, 2026

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NEWS

Imagene AI Partners with Daiichi Sankyo to Advance Multimodal Biomarker Discovery in Oncology

Imagene AI has entered into a collaboration with Daiichi Sankyo to advance biomarker discovery and response prediction across oncology drug development programs Under the collaboration, Daiichi Sankyo will leverage Imagene’s OI Suite, powered by the CanvOI foundation model, to integrate H&E and IHC whole-slide images with molecular and clinical data to enhance biomarker identification and…
April 10, 2026

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