CorTec Receives Second FDA Breakthrough Device Designation for Brain Interchange system

Shots: The US FDA has granted Breakthrough Device Designation to Brain Interchange system for communication in people with non-progressive quadriplegia, letting users to control a computer cursor through thought alone The new designation builds on Brain Interchange’s April 2026 BDD for stroke motor rehabilitation. The same implant can function therapeutically by stimulating the brain to…

ByRidhi Rastogi10 hours ago

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PharmaEssentia Reports the US FDA Approval of BESREMi (Ropeginterferon Alfa-2b-njft) for Essential Thrombocythemia

Shots: The US FDA has approved BESREMi (ropeginterferon alfa-2b-njft) for the treatment of adults with essential thrombocythemia (ET), expanding BESREMi product label beyond polycythemia vera Approval was supported by durable ELN responses and hematologic control in adults with ET. In P-III (SURPASS-ET) trial, it outperformed anagrelide in durable response rates & reduced thromboembolic events over…

ByRidhi Rastogi16 hours ago

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Arrowhead Reports P-III (SHASTA-3 & 4) Trial Data on Redemplo (Plozasiran) for Severe Hypertriglyceridemia at ESC’26

Shots: P-III (SHASTA-3 & 4) trials, assessing Redemplo (25mg, SC, Q3M) vs PBO in sHTG adults (n=757), met their 1 & 2EPs, showing median TG reductions of 79% & 81%, respectively, at 12mos. In pts with TG ≥880mg/dL, median TG reductions were 85% in both trials At 12mos., Redemplo enabled 91% & 93% pts in…

ByRidhi Rastogi1 day ago

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Gilead’s Bixlenvo Secures US FDA Approval for Virologically Suppressed Adults With HIV

Shots: The US FDA has approved Bixlenvo (bictegravir 75mg/lenacapavir 50mg) for the treatment of HIV in adults who are virologically suppressed Approval was based on the P-III (ARTISTRY-1 & ARTISTRY-2) trials, assessing Bixlenvo (QD, PO) in adults with HIV who are virologically suppressed, incl. those who switched from complex multi-tablet regimens or from Biktarvy In…

ByRidhi Rastogi2 days ago

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Takeda Reports the US FDA Approval of Mimrylo (Rusfertide) for Polycythemia Vera

Shots: The US FDA has approved Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV) Approval was backed by the P-III (VERIFY) trial (n=293), which met all efficacy endpoints, showing higher response rates, reduced need for phlebotomy & improvement in fatigue as measured by PROMIS Fatigue Short Form 8a The VERIFY…

ByRidhi Rastogi2 days ago

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SOTIO Biotech Receives FDA Fast Track Designation for SOT106 to Treat Soft Tissue Sarcoma

Shots: The US FDA has granted Fast Track Designation (FTD) to SOT106 for the treatment of soft tissue sarcoma SOT106 is an ADC that targets LRRC15, a clinically validated target broadly expressed across multiple prevalent sarcoma subtypes, & has received FDA Orphan Drug Designation for osteosarcoma treatment SOTIO plans to initiate a first-in-human clinical trial of SOT106…

ByRidhi Rastogi4 days ago

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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 Rastogi5 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 RastogiAugust 27, 2026

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Celcuity Reports the US FDA sNDA Submission for Revtorpyk for HR+/HER2-, PIK3CA Mutant Breast Cancer

Shots: The US FDA has received sNDA for Revtorpyk (gedatolisib) for the treatment of pts with HR+, HER2-, locally advanced or metastatic breast cancer with a PIK3CA mutation, following progression on or after treatment with ≥1L of endocrine therapy sNDA was supported by the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of Revtorpyk + fulvestrant ±…

ByRidhi RastogiAugust 27, 2026

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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 RastogiAugust 27, 2026

CorTec Receives Second FDA Breakthrough Device Designation for Brain Interchange system

PharmaEssentia Reports the US FDA Approval of BESREMi (Ropeginterferon Alfa-2b-njft) for Essential Thrombocythemia

Arrowhead Reports P-III (SHASTA-3 & 4) Trial Data on Redemplo (Plozasiran) for Severe Hypertriglyceridemia at ESC’26

Gilead’s Bixlenvo Secures US FDA Approval for Virologically Suppressed Adults With HIV

Takeda Reports the US FDA Approval of Mimrylo (Rusfertide) for Polycythemia Vera

SOTIO Biotech Receives FDA Fast Track Designation for SOT106 to Treat Soft Tissue Sarcoma

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

Celcuity Reports the US FDA sNDA Submission for Revtorpyk for HR+/HER2-, PIK3CA Mutant Breast Cancer

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

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