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BioWorld - Sunday, March 1, 2026
Home » Topics » Regulatory

Regulatory
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Demand for obesity drugs a golden opportunity for counterfeits

May 26, 2023
By Mari Serebrov
Mixing a trendy drug for a global health problem like obesity with a demand that far exceeds the supply cooks up a recipe too good for counterfeiters to ignore. That’s the problem patients are facing with Novo Nordisk A/S’ semaglutide products, Ozempic and Wegovy, which have been in short supply all over the world since early last year due to significant, and unexpected, demand for weight management.
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EU flag, pills, syringe

Otsuka’s schizophrenia drug filing U-turn amongst latest CHMP announcements

May 26, 2023
By Caroline Richards
Otsuka Pharmaceutical Co. Ltd. has gone back on efforts to get its medicine, Asimtufii (aripiprazole), a long-acting maintenance treatment for schizophrenia, approved in Europe, after the EMA gave a provisional negative opinion.
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Regulatory actions for May 26, 2023

May 26, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accropeutics, Applied Therapeutics, Celltrion, Dyne, Hibio, Janssen, Legend, Pfizer, Sandoz.
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3D illustration of transparent human torso with close up of spinal cord

Locate Bio receives breakthrough nod for Ldgraft spine fusion system

May 25, 2023
By Nuala Moran
The U.S. FDA has awarded Locate Bio Ltd. a breakthrough device designation for its Ldgraft spine fusion product for the treatment of degenerative disk disease, paving the way to the first in human study later this year.
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Oral COVID-19 antiviral Paxlovid wins full FDA approval

May 25, 2023
Pfizer Inc.’s Paxlovid (nirmatrelvir/ritonavir) became the first oral antiviral to win full U.S. FDA approval for treating COVID-19, cleared for use in adults who are at high risk for progression to severe disease, including hospitalization or death. The nod follows two months after the agency’s Antimicrobial Drugs Advisory Committee voted 16-1 in favor of Paxlovid’s overall benefit-risk assessment.
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Bayer’s PI3K inhibitor cleared in China for follicular lymphoma

May 25, 2023
By Doris Yu
Bayer AG’s copanlisib was approved in China for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. It is the first indication approved in the country for copanlisib, which is entering a market with room to grow but marked by some domestic competition.
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Regulatory actions for May 25, 2023

May 25, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allos, Astrazeneca, Bioray, Braeburn, Innoviva, Inovio, Phathom, Sarepta, Tryp.
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Regulatory actions for May 25, 2023

May 24, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Kane Biotech.
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Regulatory actions for May 24, 2023

May 24, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Zoll Medical.
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endoangel.jpg

Endoangel’s AI-based diagnosis system for endoscopy is approved in China

May 24, 2023
By Doris Yu
Wuhan Endoangel Medical Technology Co. Ltd.’s artificial intelligence (AI)-assisted real-time quality control and auxiliary diagnosis system for lower gastrointestinal endoscopy has been approved by China’s NMPA.
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