Skip to content Skip to footer
Subscribe Now
NEWS

Novartis’ Rhapsido Receives the EC’s Approval for Chronic Spontaneous Urticaria 

Shots:  The EC has approved Rhapsido (Remibrutinib) for the treatment of adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment  Approval was supported by P-III (REMIX-1 & 2) trials (n=925) in CSU pts, where remibrutinib showed superior improvements in itch, hives & weekly urticaria activity at Wk.12 vs PBO in pts uncontrolled on H1-antihistamines, with a favorable safety profile…
April 23, 2026

Read more

Ipsen Pharmaceuticals
NEWS

Ipsen’s Ojemda (Tovorafenib) Receives Conditional Approval for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG) in the EU

Shots: The EC has granted conditional approval to Ipsen's Ojemda as a monotx. for the treatment of pts (≥6mos.) with pLGG harbouring a BRAF fusion or rearrangement or BRAF V600 mutation, who have progressed after ≥1 prior systemic therapy, across all 30 EEA states Approval was based on the P-II (FIREFLY-1) trial assessing Ojemda (QW, PO)…
April 22, 2026

Read more

NEWS

Astellas and Pfizer Gain FDA Priority Review for Padcev + Keytruda in Muscle-Invasive Bladder Cancer (MIBC), Regardless of Cisplatin Eligibility

Shots: The US FDA has accepted sBLA & granted priority review to perioperative Padcev + Keytruda/Keytruda Qlex for the treatment of pts with MIBC, regardless of cisplatin eligibility (PDUFA: Aug 17, 2026) sBLA was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs…
April 21, 2026

Read more

Moderna
NEWS

Moderna Reports the EC Approval of mCOMBRIAX to Protect Against Influenza and COVID-19    

Shots:  The EC has approved mCOMBRIAX (mRNA-1083), a combination vaccine for the prevention of influenza and COVID-19 in patients ≥50 yrs. across all 30 EEA states    Approval was based on a P-III trial evaluating mRNA-1083 in ~8,000 adults across two cohorts: ≥65yrs (n~4,000) vs co-administered Fluzone / Efluelda (a high dose influenza vaccine )+ Spikevax and 50–64yrs (n~4,000) vs Fluarix + Spikevax, where all 1EPs were met, demonstrating non-inferiority of immune response with acceptable safety and tolerability    MRNA-1010, Moderna’s…
April 20, 2026

Read more

Bavarian Nordic
NEWS

Bavarian Nordic Reports Swissmedic’s Approval of Vimkunya to Prevent Chikungunya

Shots: Swissmedic has approved Vimkunya (recombinant, adsorbed) for active immunization against CHIKV disease in individuals (≥12yrs.) Vimkunya is a single-dose, prefilled VLP-based chikungunya vaccine for individuals ≥12 years, designed to trigger rapid immunity with responses starting as early as 1 week Bavarian Nordic has submitted a Health Canada application, with potential chikungunya vaccine approval in…
April 17, 2026

Read more

NEWS

AOP Health Reports the US FDA Approval Rapiblyk (Landiolol) for Pediatric Patients with Supraventricular Tachycardia

Shots: The US FDA has approved Rapiblyk (landiolol) for use in pediatric pts (from birth to <18 years of age) with supraventricular tachycardia (SVT), expanding its use beyond adults Approval was supported by the LANDI-PED study (n=60), which showed >20% reduction in ventricular rate, demonstrating clinically meaningful heart rate control in this patient subgroup Rapiblyk…
April 16, 2026

Read more

Load more