NEWS

Takeda Presents P-III (FirstLight & RadiantLight) Trial Data on Oveporexton for Narcolepsy Type 1 (NT1) at SLEEP 2026

Shots: The Takeda's P-III (FirstLight & RadiantLight) trial assessed oveporexton (BID) in NT1 pts over 12wks, where FirstLight randomized 168 pts to 3 arms (2mg, 1mg & PBO), while RadiantLight randomized 105 pts to two arms (2mg & PBO); regulatory filing is under review in the US (priority review), China & Japan At Wk. 12,…

June 16, 2026

The US FDA Accepts Gilead’s Once-Weekly Oral Yeztugo for Review as a PrEP Therapy for HIV Prevention

Shots: The US FDA has accepted sNDA of Yeztugo (300mg, QW, PO) as a pre-exposure prophylaxis therapy for the prevention of HIV (PDUFA: Feb 02, 2027) sNDA was supported by the P-III (PURPOSE 1 & PURPOSE 2) trials of Yeztugo, which demonstrated high efficacy across diverse global populations, incl. cisgender women, cisgender men & gender-diverse…

June 16, 2026

Elanco Receives the USDA Approval for TruCan Ultra Lyme-L4 Combination Vaccine to Protect Dogs Against Lyme and Leptospirosis

Shots: The USDA has approved Elanco's TruCan Ultra Lyme-L4 to protect dogs against both Lyme disease and leptospirosis, expanding its extensive TruCan Ultra Portfolio TruCan Ultra Lyme-L4 uses Elanco’s PureFil Tech to reduce vaccination reactions & is available in a 1/2mL formulation that delivers the same broad protection as the 1 mL version, enabling comprehensive…

June 16, 2026

Akeso Reports First Patient Enrolment in P-Ib/II Trial of AK138D1 ± Ivonescimab for Breast Cancer

Shots: Akeso has enrolled the first patient in the P-Ib/II (AK138D1-202) study assessing its AK138D1 monotx. or in combination with ivonescimab for the treatment of advanced breast cancer The trial is evaluating AK138D1 in 2 breast cancer subtypes: HR+/HER2- & triple-negative breast cancer. The study incl. pts ranging from treatment-naïve to heavily pretreated & enrolls…

June 15, 2026

Eli Lilly Reports P-I (AJX-101) Trial Data on AJ1-11095 in Previously Treated Myelofibrosis

Shots: Eli Lilly reported the P-I (AJX-101) trial, assessing AJ1-11095 (25, 50, 75, 100, & 125mg, QD) in 23 pts with myelofibrosis who have been failed by a type I JAK2 inhibitor, at EHA 2026 AJ1-11095 achieved a 70% SVR35 & 70% TSS50 rate at Wk. 12, with driver mutation VAF reductions observed in 21 pts;…

June 15, 2026

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

SteinCares Receives ANVISA Approval for Uztok (Biosimilar, Stelara)

Shots: The ANVISA has approved Uztok, a biosimilar version of Stelara (ustekinumab) Ustekinumab is a human interleukin-12 and -23 antagonist Uztok is indicated for Plaque psoriasis, Psoriatic arthritis, Crohn's disease, and Ulcerative colitis Ref: Gov.br | Image: SteinCares | Press Release Related News: Celltrion Plans to File for Approval of Herzuma SC (Biosimilar, Herceptin) in Europe and Korea PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with…

June 15, 2026

Celltrion Receives ANVISA Approval for Eydenzelt (Biosimilar, Eylea)

Shots: The ANVISA has approved Eydenzelt, a biosimilar version of Eylea (aflibercept) Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor Eydenzelt is indicated for adults with wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (CRVO/BRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (CNV) Ref: Gov.br | Image: Celltrion | Press Release Related News: Celltrion Plans to File for Approval of Herzuma SC (Biosimilar, Herceptin) in Europe and Korea …

June 15, 2026

Sanofi’s Tzield Secures FDA Accelerated Approval to Preserve Endogenous Insulin Production in Recently Diagnosed Stage 3 T1D

Shots: The US FDA has granted accelerated approval to Sanofi's Tzield to delay the decline in endogenous (own) insulin production in pts (8-17yrs.) recently diagnosed with stage 3 T1D Approval was based on the P-III (PROTECT) trial assessing Tzield (n=217) vs PBO (n=111) in 328 children & adolescents (8-17yrs.) diagnosed with clinical stage 3 T1D…

June 15, 2026

Merck Reports FDA Approval of Keytruda/Keytruda QLEX + Welireg in Clear Cell Renal Cell Carcinoma

Shots: The US FDA has approved MSD's Welireg + Keytruda/Keytruda QLEX as adj. therapy in clear cell renal cell carcinoma (ccRCC) pts at intermediate-high or high risk of recurrencepost-nephrectomy or post-nephrectomy & resection of metastatic lesions Approval was backed by the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO)…

June 15, 2026

Takeda Presents P-III (FirstLight & RadiantLight) Trial Data on Oveporexton for Narcolepsy Type 1 (NT1) at SLEEP 2026

The US FDA Accepts Gilead’s Once-Weekly Oral Yeztugo for Review as a PrEP Therapy for HIV Prevention

Elanco Receives the USDA Approval for TruCan Ultra Lyme-L4 Combination Vaccine to Protect Dogs Against Lyme and Leptospirosis

Akeso Reports First Patient Enrolment in P-Ib/II Trial of AK138D1 ± Ivonescimab for Breast Cancer

Eli Lilly Reports P-I (AJX-101) Trial Data on AJ1-11095 in Previously Treated Myelofibrosis

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

SteinCares Receives ANVISA Approval for Uztok (Biosimilar, Stelara)

Celltrion Receives ANVISA Approval for Eydenzelt (Biosimilar, Eylea)

Sanofi’s Tzield Secures FDA Accelerated Approval to Preserve Endogenous Insulin Production in Recently Diagnosed Stage 3 T1D

Merck Reports FDA Approval of Keytruda/Keytruda QLEX + Welireg in Clear Cell Renal Cell Carcinoma

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