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Eisai and Biogen Report EU Launch of Leqembi (Lecanemab) to Treat Alzheimer’s Disease
NEWS

Biogen and Eisai Report NMPA Approval of Leqembi (SC) as an Initiation Dose for Early Alzheimer’s Disease

Shots: The NMPA has approved Leqembi (SC autoinjector/SC-AI) as an initiation dose administered as 500mg given QW as two consecutive 250mg injections, each delivered in ~15secs, for the treatment of early Alzheimer's disease  Approval was supported by 18mos. P-III Clarity AD data & multiple SC administration sub-studies (incl. Chinese cohort), with SC-AI 500mg (QW) showing…
September 3, 2026

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NEWS

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…
September 1, 2026

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NEWS

Zambon Secures the EC Approval for Hopledo to Treat Parkinson’s Disease and Moderate to Severe Motor Fluctuations

Shots: The EC has approved Hopledo for the treatment of adults with Parkinson’s disease & mod. to sev. motor fluctuations who have not been sufficiently stabilized with oral levodopa/DDC inhibitor-based treatments Approval was based on the P-III (RISE-PD) trial assessing Hopledo in pts with Parkinson’s disease & mod. to sev. motor fluctuations, which showed a…
August 31, 2026

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Gilead
NEWS

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…
August 31, 2026

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Roche
NEWS

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…
August 27, 2026

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NEWS

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…
August 27, 2026

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