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The FDA’s new transparency policy (Part 3)
As transparency and consistency become increasingly emphasized by the FDA, medical device manufacturers must approach their submissions with both thoroughness a...
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Canada approves leqembi as global alzheimer’s drug race heats up
Leqembi has secured approval in Canada, further consolidating its global lead among disease-modifying Alzheimer’s therapies. The antibody is now authorized in 1...
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Efter stökig process – nu godkänns Leqembi i Australien
Det svenskutvecklade alzheimerläkemedlet Leqembi har till slut godkänts i Australien, efter flera komplicerade turer.
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ZEISS showcases comprehensive workflow for full spectrum of retina care at EURETINA
ZEISS Medical Technology combines its diagnostic, surgical and digital technologies to support healthcare professionals in advancing retinal care.
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ZEISS announces CE mark for CIRRUS PathFinder AI tool with automated OCT assessment
Fully integrated AI decision support tool flags B scans that may require further review, supporting more confident decision making and more efficient patient care.
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The FDA’s new transparency policy (Part 2)
In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...
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Allogene discontinues investigational antibody following patient death
U.S. biotechnology company Allogene Therapeutics is fully discontinuing the use of its experimental antibody ALLO-647 following the death of a patient in its pi...
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The race between new alzheimer’s drugs Kisunla and Leqembi heats up
Kisunla or Leqembi? The rivalry between Eli Lilly and Bioarctic is intensifying. Where one drug gains approval, the other falls behind. Here's a look at the mar...
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Marie Gårdmark: “What to expect from Trump’s second term?”
One may complain about the complex multinational system in EU, but it gives us some predictability that cannot be easily overturned by different member states p...
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AstraZeneca´s Trixeo approved in the UK using propellant with near-zero Global Warming Potential
AstraZeneca has received approval in the United Kingdom for its inhaled respiratory medicine Trixeo Aerosphere with a new propellant that is reported to reduce ...
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Eli Lilly requests re-examination of Alzheimer's drug recommendation
Eli Lilly has requested that the EMA re-examine its opinion on the company's Alzheimer's drug, Kisunla, the agency announced on Friday.
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Tau-targeted Alzheimer's drug gets Fast Track designation in the USA
Biogen's Alzheimer's candidate BIIB080 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
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Security flaw in Swedish breast cancer screening software – woman passed away
A lack of safeguard in Sectra's software led to a woman with breast cancer receiving an incorrect diagnosis. She later passed away. The software is used in 20 o...
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Quretech granted a European patent for a new type of antibiotic
The European patent provides protection until 2041. Previously, the patent was granted in China, and the application is currently under review in the USA, India, and Japan.
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FDA’s Top Vaccine Official resigns – Issues sharp criticism of Kennedy
FDA’s Top Vaccine Official is leaving his post while simultaneously criticizing the country’s health secretary for allowing “misinformation and lies” to influen...
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EMA review confirms a risk of new cancer after CAR-T
CAR-T cancer therapies can, in rare cases, induce secondary cancers. The European Medicines Agency (EMA) now recognises this and requires a warning label to be ...
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Leqembi får nobben i Australien – igen
Alzheimerläkemedlet Leqembi (lekanemab) nekas återigen marknadsgodkännande i Australien.
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Career coach on salaries: “There is no right or wrong”
What is a reasonable salary for my job? It's a question we all ask ourselves. But how important is a higher salary really? Career coach Tina Persson believes th...
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Stora tidskriftsförlag stämda – ”Pengar har dikterat möjligheten att nå ut med forskning”
Just nu pågår en rättsprocess i USA mot sex stora förlag för vetenskapliga tidskrifter. En grupp forskare hävdar att förlagen ”konspirerat” på ett sätt som förh...
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Joy at Egetis after positive CHMP opinion – ”The single most important milestone”
Stockholm-based Egetis Therapeutics has received a positive CHMP opinion for Emcitate, which could become the first approved treatment for the rare disease MCT8 deficiency."
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Misstänkt koppling mellan Ozempic och ögonsjukdom – myndighet reagerar
Två nya danska studier har pekat på en koppling mellan Ozempic (semaglutid) och en möjlig risk för den sällsynta ögonsjukdomen NAION. Nu vill danska läkemedelsv...
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Assignment: Facilitate the retention of foreign researchers
A newly appointed public inquiry is to develop measures to make attracting and retaining foreign doctoral students and researchers in Sweden easier.
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Rising interest in CRISPR treatments
Treatments using CRISPR technology are emerging as one of the hottest medical trends in the United States – and the FDA is doing its best to promote the development.
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Stark uppgång för Crispr-behandlingar
Behandlingar som använder gensaxen Crispr växer fram som en av de hetaste medicinska trenderna i USA – och läkemedelsmyndigheten FDA gör sitt bästa för att stöd...
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