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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,…
16 hours ago

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NEWS

Incyte to Acquire Vega Therapeutics for ~$2B

Shots: Incyte has entered into a definitive agreement to acquire Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics, to expand its hematology portfolio into bleeding disorders As per the deal, Incyte will acquire Vega for $1.25B upfront, with ~$750M in additional payments upon achievement of sales milestones Acquisition will expand Incyte’s hematology portfolio with…
2 days ago

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NEWS

BMS Partners with Hengrui Pharma in a Potential ~$15.2B Deal to Advance 13 Early-Stage Programs Across Oncology, Hematology, and Immunology

Shots: BMS has partnered with Hengrui to advance 13 early-stage programs, incl. 4 Hengrui onco/hemo assets, 4 BMS immunology assets, and 5 jointly discovered & developed candidates; expected to close in Q3’26 Hengrui will lead early clinical development, while BMS gains ex-China rights to Hengrui-originated assets & Hengrui will secure exclusive Greater China rights to…
May 12, 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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Novo-Nordisk
NEWS

Novo Nordisk Reports Positive P-III (HIBISCUS) Study Data for Etavopivat in Sickle Cell Disease

Shots: Novo Nordisk reported that etavopivat met both co-1EPs in the P-III (HIBISCUS) study, reducing vaso-occlusive crises (VOCs) and improving haemoglobin response in sickle cell disease The study (n=385, ≥12yrs) evaluated Etavopivat (400mg) vs PBO demonstarting reduced VOCs rates by 27% and delayed time to first VOC (~38.4 vs 20.9 weeks), while 48.7% of patients…
April 20, 2026

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Sanofi
NEWS

Sanofi Reports the EC Approval of Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD) 

Shots:  The EC has approved Rezurock (200mg) to treat chronic GVHD pts (≥12yrs., ≥40kg)  Approval was based on safety and efficacy clinical data, incl. the P-II (ROCKstar) trial (n=77), which showed an improved ORR of 74% in chronic GVHD pts post–stem cell transplant & after ≥2 prior systemic therapies  Under the conditional marketing authorisation, Sanofi will conduct a confirmatory randomized study Ref:…
March 26, 2026

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NEWS

Johnson & Johnson Receives the US FDA’s Approval for Darzalex FASPRO Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The US FDA has approved Darzalex FASPRO (daratumumab and hyaluronidase-fihj) + bortezomib, lenalidomide & dexamethasone (D-VRd) for adults with NDMM who are ineligible for autologous stem cell transplant. Approval was based on the P-III (CEPHEUS) trial, assessing D-VRd vs VRd in 395 ASCT-ineligible or deferred patients across 13 countries in the EU, North America,…
January 28, 2026

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NEWS

MS Pharma enters an exclusive biosimilar partnership with Hetero 

Shots:  MS Pharma has signed a strategic partnership with Hetero to localize five established biosimilars across key areas, including oncology, immunology, and hematology, in the MENA region  The exclusive agreement will be implemented through El Kendi (MS Pharma Group’s Algeria affiliate) and Hetero Biopharma, a subsidiary of Hetero Group  This marks Hetero’s first local partnership in Algeria, supporting…
January 26, 2026

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