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FDA Approved stamp

US FDA approves Novartis’ radioligand therapy and imaging agent for metastatic prostate cancer

March 24, 2022
By Lee Landenberger
The U.S. FDA has approved Novartis AG’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan, formerly referred to as 177Lu-PSMA-617) for treating adults with metastatic prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. The treatment is the indication’s first FDA-approved targeted radioligand therapy that contains a radioisotope.
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Regulatory actions for March 24, 2022

March 24, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Emmaus, Moberg, Morphosys, Novavax, Phanes, Secura, Silence, TC, Xcovery.
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Regulatory actions for March 23, 2022

March 23, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Artio Medical, Cerus Endovascular, SIS Medical.
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Green traffic light

FDA gives green light to Artio Medical occlusion device

March 23, 2022
By Catherine Longworth

The FDA cleared a peripheral vascular occlusion product developed by Artio Medical Inc. The Solus Gold embolization device is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.


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Federal Circuit tersely affirms PTAB rejection of a BSX patent

March 23, 2022
By Mark McCarty

Patent law cases are known for lengthy, intricate arguments and explanations, but a recent decision by the U.S. Court of Appeals for the Federal Circuit flew against this trend. 


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Broncus thermal vapor treatment system wins NMPA approval

March 23, 2022
By Zhang Mengying
Broncus Holding Corp.’s thermal vapor treatment system Intervapor has won approval from China’s NMPA. The system is used for the treatment of chronic obstructive pulmonary disease (COPD), lung cancer and other pulmonary diseases.
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Woman using eyedrops

Changes in store for US ophthalmic products

March 23, 2022
By Mari Serebrov
Citing a court order for its haste, the U.S. FDA skipped the draft and went straight to issuing a final guidance that will change how certain ophthalmic drugs are regulated.
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FDA approved icons and medical professional

FDA medical device user fee deal calls for more than 300 enrollees in new TAP program

March 23, 2022
By Mark McCarty

The U.S. FDA has finally unveiled the fifth edition of the device user fee program (MDUFA V), and some of the performance measures remain unchanged from MDUFA IV, such as that the FDA will process 95% of 510(k) filings within 90 days.


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Novavax’s COVID-19 vaccine granted EUA for adolescents in India

March 23, 2022
By David Ho
The Drugs Controller General of India has granted Novavax Inc. and the Serum Institute of India Pvt. Ltd. emergency use authorization (EUA) for Novavax’s protein-based COVID-19 vaccine. It was authorized for use in adolescents aged 12 to 18 years. The vaccine will be manufactured and marketed in India by the Serum Institute under the brand name Covovax.
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FDA website and logo

Drug companies, US FDA burying the lede on accelerated approval

March 23, 2022
By Mari Serebrov
As congressional scrutiny of the U.S. FDA’s accelerated approval path continues, the agency is focusing research efforts into appropriate disclosure on direct-to-consumer websites about a drug’s accelerated approval and the status of confirmatory trials. Previous research by the FDA’s Office of Prescription Drug Promotion (OPDP) found that 27% of DTC websites providing information about a drug with accelerated approval don’t disclose that the products are on the market through accelerated approval.
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