Merck receives priority review from FDA for new biologics license application for sotatercept, an activin signaling inhibitor to treat adults with pulmonary arterial hypertension

28 September 2023 - Application based on clinically meaningful results from the Phase 3 STELLAR trial. ...

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US FDA approves BioMarin's Roctavian (valoctocogene roxaparvovec-rvox), the first and only gene therapy for adults with severe haemophilia A

29 June 2023 - Roctavian's approval was based on durability, efficacy and safety results from the largest and longest Phase 3 ...

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FDA approves Bayer’s Ultravist (iopromide) injection for contrast-enhanced mammography

23 June 2023 - Ultravist-300, -370 is now the only contrast agent in the US indicated to visualise known or suspected ...

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FDA launches pilot program to help reduce risks associated with using laboratory developed tests to identify cancer biomarkers

20 June 2023 - Pilot geared toward sponsors of certain oncology drug products used with certainin vitro diagnostic tests ...

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Legend Biotech announces submission of supplemental application to the US FDA for expanded use of Carvykti (ciltacabtagene autoleucel)

6 June 2023 - The application is supported by the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint ...

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FDA approves first gene therapy for the treatment of high risk, non-muscle invasive bladder cancer

16 December 2022 - Today, the US FDA approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating adenoviral vector based gene therapy indicated for ...

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Opsens announces FDA clearance for the SavvyWire for use in transcatheter aortic valve replacement procedures

15 September 2022 - OpSens today announced that it has received 510(k) regulatory clearance from the US FDA for the SavvyWire, ...

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FDA accepts CSL Behring's biologics license application for etranacogene dezaparvovec for priority review

24 May 2022 - If approved, etranacogene dezaparvovec would be the first gene therapy option for people living with haemophilia B. ...

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Athenex provides update from FDA Type A meeting regarding oral paclitaxel plus encequidar for the treatment of metastatic breast cancer

6 July 2021 - Athenex today announced that the Company held a Type A meeting with the U.S. FDA during the ...

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FDA approves first treatment for patients with plasminogen deficiency, a rare genetic disorder

4 June 2021 - Today, the U.S. FDA approved Ryplazim (plasminogen, human-tmvh) for the treatment of patients with plasminogen deficiency type ...

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Varian receives FDA breakthrough device designation for its cardiac radioablation system for treatment of refractory ventricular tachycardia

26 May 2021 - Varian's CRA system has been designated a "breakthrough device" by the FDA because of its potential to ...

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Roche receives FDA approval for Ventana ALK (D5F3) CDx assay to identify lung cancer patients eligible for targeted treatment with Lorbrena (lorlatinib)

9 March 2021 - The Ventana ALK (D5F3) CDx Assay is now FDA approved as a companion diagnostic in four targeted ...

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Oxford developed COVID-19 vaccine, then scholars clashed over money

21 October 2020 - Early deal with Merck was scotched for fear poor countries would be left out; now university could ...

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All eyes on a hurdle race for a SARS-CoV-2 vaccine

19 October 2020 - Leading COVID-19 vaccine candidates have progressed through laboratory tests at record speed.  ...

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Investigators propose different measures for biosimilar equivalence

12 May 2020 - Investigators use the HERITAGE trial findings to argue for a more precise way of measuring clinical equivalence ...

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