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BioWorld - Thursday, June 12, 2025
Home » Topics » Regulatory

Regulatory
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China gives thumbs up to Innovent’s taletrectinib for lung cancer

Dec. 23, 2024
By Tamra Sami
China's National Medical Products Administration (NMPA) approved Innovent Biologics Inc.’s NDA for Dovbleron (taletrectinib), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for treating adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs.
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Year in review 2024 - US lawsuits

Year’s top US court cases to present new challenges for 2025

Dec. 23, 2024
By Mari Serebrov
As if the uncertainties surrounding an incoming administration weren’t enough, a landmark U.S. Supreme Court decision and a potential new avenue of liability for drug and device manufacturers could bring an added level of unpredictability to the sector for 2025.
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Laptop displaying FDA logo

Lexicon Zynquista vista narrows with diabetes CRL; gain due in pain?

Dec. 23, 2024
By Randy Osborne
As recently as last month, Lexicon Pharmaceuticals Inc. was holding out hope regarding the NDA for Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD), with analysts mulling the potential label.
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Alyftrek specs check out in cystic fibrosis as Vertex wins FDA nod

Dec. 23, 2024
By Randy Osborne
Vertex Pharmaceuticals Inc.’s chief operating officer Stuart Arbuckle said during the Stifel Healthcare Conference in November that his firm’s launch last year of Casgevy (exagamglogene autotemcel) for sickle cell disease and transfusion-dependent beta-thalassemia “was the beginning of diversifying on top of our cystic fibrosis [CF] base” – a base that itself continues to grow.
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Illustration of blood vessel injury being repaired by red blood cells and platelets

Novo’s injectable hemophilia treatment approved by FDA

Dec. 23, 2024
By Lee Landenberger
With Alhemo (concizumab-mtci) from Novo Nordisk A/S, a third hemophilia drug in the past eight months has been approved by the U.S. FDA. The once-daily injectable prophylaxis is to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B with inhibitors.
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Hand holding FDA blocks

​FDA releases second advisory under early alert program​

Dec. 23, 2024
By Mark McCarty
The U.S. FDA posted another early advisory, this time for the Mini PCNL devices by Trokamed GmbH. The agency noted that these devices should not be used for suction and irrigation of surgical sites, a use for which the device was not cleared in the first place.
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Acryl

Acryl cleared as Korea’s first AI DTx to screen, diagnose depression

Dec. 23, 2024
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety cleared Acryl Inc.’s Acryl-D01 as the country’s first AI-based digital therapeutic software solution to aid depression screening and diagnosis on Dec. 20. Approved as a class II software as a medical device, Acryl-D01 utilizes a patient’s medical records to quantify and analyze the individual’s emotional response and assess the probability of having clinical depression based on the data.
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Judge's gavel with US flag
End of Year

FDA likely to see more legal challenges to rulemaking, guidance in 2025

Dec. 23, 2024
By Mark McCarty
The U.S. FDA’s authority was challenged on a number of occasions over the past few decades, but the rate is likely to pick up as the U.S. Supreme Court ruled recently that the agency cannot take judicial deference for granted any longer. Chad Landmon of the D.C. office of Polsinelli told BioWorld that future litigation against the FDA may extend even to sub-regulatory guidance thanks to the outcome in the case of Loper Bright – a scenario in which industry might carve out a few significant wins in the coming year.
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Monoclonal antibody illustration
Cancer

177Lu-RAD-202 approved for therapeutic phase I in Australia

Dec. 23, 2024
Radiopharm Theranostics Ltd. has been granted Belberry Human Research Ethics Committee (HREC) approval in Australia to initiate a first-in-human phase I therapeutic study of 177Lu-labeled RAD-202 (177Lu-RAD-202) for the treatment of HER2-expressing solid tumors, including breast and gastric cancers.
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Red blood cells
Hematologic

Vanda’s VGT-1849A gets orphan designation for polycythemia vera

Dec. 23, 2024

Vanda Pharmaceuticals Inc.’s VGT-1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor, has been awarded orphan drug designation by the FDA for the treatment of polycythemia vera.


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