The FDA has announced a sweeping policy change: the longstanding requirement for two rigorous clinical studies to win new drug approval is being replaced by a single-pivotal-trial standard. Agency leaders argue that "in 2026 there are powerful alternative ways to feel assured that our products help people" beyond requiring manufacturers to repeat expensive trials. The NEJM published an editorial endorsing the shift as "ending the two-trial dogma." This could dramatically accelerate access to new medicines — while raising questions about the safety bar.
A new chemical entity — milsaperidone — becomes the newest antipsychotic on the market. The first-line therapy for acute manic/mixed episodes in bipolar I and for schizophrenia sent Vanda shares surging 30% after hours.
The BLA for garetosmab has been accepted with Priority Review for fibrodysplasia ossificans progressiva (FOP), a devastating ultra-rare disease where soft tissue turns to bone. PDUFA target date: August 2026. If approved, it would be the first and only treatment for FOP.
FDA greenlights AbbVie's all-oral combination for chronic lymphocytic leukemia, showing superior three-year outcomes versus chemo. Patients can now achieve time-limited therapy without IV infusions — a potential paradigm shift in CLL management.
BioNTech hat Moderna vor einem Bundesgericht in Delaware verklagt — Modernas COVID-Impfstoff mNEXSPIKE verletze BioNTech-Patente zur mRNA-Vakzintechnologie. Die mRNA-Patentkriege gehen in die nächste Runde.
Reuters / Insurance Journal2 min
FDATop drug regulator signals closer scrutiny of antidepressants and RSV infant shots in first address to staff STAT News
A landmark compassionate-use study in Nature Medicine reports that the CD19×CD3 T cell engager blinatumomab and the BCMA×CD3 engager teclistamab achieved rapid clinical, serological, and histological improvement in patients with refractory antisynthetase syndrome and systemic sclerosis, respectively. The study demonstrates that bispecific antibodies — originally developed for hematologic cancers — can be repurposed as powerful rescue therapies in autoimmunity. CRS up to grade 3 was observed, but no ICANS occurred.
Düsing et al., Nature Medicine·Feb 19, 20264 min read
A provocative review explores engineered tumor cells as therapeutic delivery vehicles — from "killer vaccines" and APC-like reprogramming to Trojan horse oncolytic virus delivery. Draws lessons from CAR-T's clinical evolution for translational challenges.
MEK inhibitors target macrophage overactivation — a key driver of cytokine release syndrome in CAR-T therapy — without impairing T cell killing. A potential new strategy for managing CAR-T toxicity while preserving anti-tumor activity.
The 61st Venice Biennale Arte runs May 9 – November 22, showcasing international artists across the Giardini and Arsenale. New for 2026: the expanded day-tripper access fee (April–July) aims to ease overtourism during peak months. Advance booking required. The MOSE flood-barrier system continues protecting the city from acqua alta, and local businesses report positive feedback from the crowd-management measures. Venice is positioning itself as a model for sustainable cultural tourism.
ITA Airways staff walkouts and rail strikes are causing delays across Milan, Rome, and Venice airports. The February 16 airport strike was postponed due to the Milano Cortina Winter Olympics — but new dates are expected. Check before booking.
Praktische Tipps für einen Besuch der ikonischen Trulli-Häuser in Puglia — die besten Fotospots, versteckte Ecken abseits der Touristenströme, und was man über das UNESCO-Welterbe wissen sollte. Perfekte Frühlings-Reiseplanung.
Sonntag 22.2., 11:00 Uhr im Ehrbar Saal. Der Ehrbär, das Maskottchen des Hauses, erklärt kleinen Klassikfans ab 4 Jahren das größte Streichinstrument. Mitmachen erwünscht!
Ein Stück über den Wald und seine Bewohner — in Laut- und Gebärdensprache. Ameisen, Eintagsfliegen, Wildschweine und ein Fuchs mit Ghettoblaster. Ab 25.2. im Dschungel Wien, Tickets jetzt sichern.