The US FDA Approves ViiV Healthcare’s Tivicay PD for Young Children with HIV-1

Shots: The US FDA has approved Tivicay PD (dolutegravir) in combination with other antiretrovirals for HIV-1 treatment in pediatric pts weighing ≥2kg, incl. treatment-naïve or experienced pts who have not previously received an INSTI The FDA decision follows Priority Review & is supported by data from the NIH-funded IMPAACT 2023 study & pediatric PK modeling.…

ByRidhi Rastogi2 days ago

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Roche Reports FDA Approval of HER2 Companion Diagnostics for Gastroesophageal Cancer

Shots: The US FDA has granted approval to expand the use of Pathway HER2 (4B5) & Ventana HER2 Dual ISH tests to identify HER2+ metastatic gastroesophageal adenocarcinoma (GEA), incl. gastric, GEJ & esophageal adenocarcinoma The companion diagnostics can help identify pts who may be eligible for HER2-targeted treatment with two Ziihera (zanidatamab-hrii) regimens for 1L…

ByRidhi Rastogi3 days ago

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Revolution Medicines Reports the US FDA Approval of Rasonque (Daraxonrasib) for Previously Treated Metastatic PDAC

Shots: FDA has approved Revolution’s Rasonque to treat pts with metastatic pancreatic ductal adenocarcinoma (PDAC) who have received ≥1 prior systemic therapy or who are not candidates for multiagent systemic therapy Approval was backed by P-III (RASolute 302) trial assessing Rasonque (300mg, QD, PO) vs CT, in the above-mentioned pts, regardless of RAS mutation, which met…

ByRidhi Rastogi3 days ago

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Akeso and Summit Report P-III (HARMONi-GI1) Trial Data on Ivonescimab + CT for 1L Advanced Biliary Tract Cancer

Shots: Akeso and Summit have reported interim analysis from the P-III (AK112-309/HARMONi-GI1) trial assessing ivonescimab + CT vs durvalumab + CT for the 1L treatment of advanced biliary tract cancer (BTC) Trial met its 1EP of OS, plus achieved all key 2EPs of PFS & ORR; data will be presented at the academic conference & published…

ByRidhi Rastogi4 days ago

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BeOne Medicines Reports the US FDA Approval of Tevimbra + Ziihera to Treat HER2+ GEA

Shots: The US FDA has approved the sBLA for Tevimbra (tislelizumab) + Ziihera (zanidatamab) & CT for the 1L treatment of adults with unresectable locally advanced or metastatic HER2+ gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA) Approval was based on the P-III (HERIZON-GEA-01) assessing the efficacy & safety of Ziihera+ CT, with and without Tevimbra, to the…

ByRidhi Rastogi4 days ago

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BioCryst Pharmaceuticals Reports MHLW Approval of Orladeyo for Hereditary Angioedema

Shots: The MHLW has approved Orladeyo (berotralstat) for prophylactic therapy in pediatric pts (2 to <12 yrs.) with hereditary angioedema (HAE) Approval was based on interim APeX-P trial results in pediatric pts with HAE, which showed early & sustained reductions in monthly attack rates; published in the Annals of Allergy, Asthma & Immunology BioCryst plans to launch…

ByRidhi Rastogi4 days ago

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J&J Reports US FDA Approval of Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

Shots: The US FDA has approved Imaavy (nipocalimab-aahu) for the treatment of wAIHA in pts (≥12yrs.) currently or previously treated with corticosteroids Approval was based on the P-II/III (ENERGY) trial, which assessed 2 different dose schedules of Imaavy vs PBO in 115 adults living with wAIHA for 24wks. followed by an OLE period, where pts…

ByRidhi Rastogi5 days ago

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Takeda Reports MHLW Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1

Shots: The MHLW has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults Approval was based on extensive data, incl. P-III (FirstLight & RadiantLight) trial assessing Orzeyful (BID) in NT1 pts over 12wks, where FirstLight randomized 168 pts to 3 arms (2mg, 1mg & PBO) & RadiantLight randomized…

ByRidhi RastogiAugust 24, 2026

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Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the EC Approval for Rett Syndrome

Shots: The EC has approved Daybu (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in pts (≥5yrs.) across all 30 EEA states Approval was based on the results from the P-III (LAVENDER) study, which showed improvements in core features of Rett syndrome, as measured by RSBQ & CGI-I scale co-1EPs Daybu, a synthetic analog…

ByRidhi RastogiAugust 24, 2026

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Johnson & Johnson Receives EC Approval for Tecvayli Combination for R/R Multiple Myeloma

Shots: The EMA has approved a label extension of Tecvayli (teclistamab) + Darzalex (daratumumab) for the treatment of adults with r/r multiple myeloma (RRMM) who have received ≥1 prior therapy Approval was supported by the P-III (MajesTEC-3) trial evaluating Tecvayli + Darzalex (SC) vs investigator’s choice of Darzalex (SC) & dexamethasone with either pomalidomide or bortezomib in…

ByRidhi RastogiAugust 24, 2026

The US FDA Approves ViiV Healthcare’s Tivicay PD for Young Children with HIV-1

Roche Reports FDA Approval of HER2 Companion Diagnostics for Gastroesophageal Cancer

Revolution Medicines Reports the US FDA Approval of Rasonque (Daraxonrasib) for Previously Treated Metastatic PDAC

Akeso and Summit Report P-III (HARMONi-GI1) Trial Data on Ivonescimab + CT for 1L Advanced Biliary Tract Cancer

BeOne Medicines Reports the US FDA Approval of Tevimbra + Ziihera to Treat HER2+ GEA

BioCryst Pharmaceuticals Reports MHLW Approval of Orladeyo for Hereditary Angioedema

J&J Reports US FDA Approval of Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

Takeda Reports MHLW Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1

Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the EC Approval for Rett Syndrome

Johnson & Johnson Receives EC Approval for Tecvayli Combination for R/R Multiple Myeloma

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