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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,…
2 days ago

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Astrazeneca
NEWS

AstraZeneca Reports the US FDA Approval of Baxfendy (Baxdrostat) To Treat Hard-to-Control Hypertension

Shots: The US FDA has approved AstraZeneca's Baxfendy in combination with other antihypertensive medications for the treatment of pts with uncontrolled or treatment-resistant hypertension  Approval was supported by the P-III (BaxHTN) trial assessing baxdrostat (1 or 2mg, QD, PO) vs PBO on top of SoCs in 796 pts with uncontrolled or treatment-resistant hypertension  Trial met…
May 18, 2026

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NEWS

George Medicines Partners with Ahngook Pharmaceutical to Commercialize GMRx2 in Korea

Shots: George Medicines has entered into an exclusive licensing & supply agreement with Ahngook Pharmaceutical, granting rights to seek regulatory approval & commercialize GMRx2 in Korea for the treatment of Hypertension As per the deal, George Medicines will receive an upfront licensing fee, potential regulatory & commercial milestone payments, as well as stepped royalties on…
March 12, 2026

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Novo-Nordisk
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Novo Nordisk Reveals P-III (REDEFINE 1) Trial Data on CagriSema for Cardiovascular Risk Factors

Shots: The post hoc analysis of P-III (REDEFINE 1) trial assessed CagriSema (cagrilintide 2.4mg & semaglutide 2.4mg) vs PBO & individual components effects on CV risk factors in 3,417 obese/overweight pts with ≥1 obesity-related comorbidities, & without T2D Trial showed CagriSema reduced systolic BP by -10.9 mmHg over 68wks. (vs -8.8 with semaglutide, & -2.1 with PBO),…
November 7, 2025

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Astrazeneca
NEWS

AstraZeneca Reports P-III (Bax24) Trial Data on Baxdrostat for Treatment-Resistant Hypertension

Shots: AstraZeneca has reported P-III (Bax24) trial data assessing baxdrostat (2mg; QD) + SoC vs PBO + SoC in 218 pts with treatment-resistant hypertension for 12wks. Trial achieved its 1EP, showing reduced 24hr. ambulatory systolic blood pressure at 12wks., with consistent efficacy across the day, incl. early morning; data to be presented at AHA’25 &…
October 7, 2025

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NEWS

The US FDA Approves George Medicines’ Widaplik for Hypertension in Adults

Shots: George Medicines’ Widaplik (telmisartan, amlodipine, and indapamide) has been approved by the US FDA for treating adult hypertension, including as initial therapy; launch is anticipated in Q4’25 The approval was supported by two P-III global studies showing Widaplik significantly improved blood pressure and control rates vs PBO & dual drug combinations Widaplik (GMRx2), a…
June 11, 2025

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Rona Therapeutics
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Rona Therapeutics Reports NMPA’s IND Acceptance of RN1871 for Hypertension

Shots: China’s NMPA has accepted IND application for RN1871 for hypertension, with Rona planning to advance it in P-I trial to assess its safety, PK, & preliminary efficacy in humans Preclinical studies have demonstrated AGT suppression & sustained blood pressure control, with reduced dosing frequency of RN1871 RN1871 is engineered to suppress AGT mRNA expression in the…
April 22, 2025

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