Shenzhen Sungening Biotechnology Co. Ltd. has synthesized cyclic peptides acting as proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitors potentially useful for the treatment of ...

Lundbeck A/S’s $2.6 billion acquisition of Longboard Pharmaceuticals Inc. is nearing its first major clinical test, with the company having completed randomization for a phase III trial of bexicaserin ...

As the U.S. FDA’s CDRH continues to try to wrap its head around the regulatory challenges presented by generative AI (GenAI)-enabled medical devices, it’s asking stakeholders to join the conversation ...

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Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: 858, Akeso, Attralus ...

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Shigella flexneri is the leading cause of endemic diarrhea and dysentery in some countries with low-to-middle incomes. There is still a lack of a licensed vaccine against this pathogen.

A Senate Finance subcommittee held a brainstorming session of sorts to explore ways to spur U.S. innovation to address two of the biggest threats to growing a strong domestic biotech sector. Those ...

Clinical updates for biopharma and med tech, including data readouts and publications: AC Immune, Alivecor, Amylyx, Arcato, Argenx, Astrazeneca, Avita, Billiontoone ...

Casma Therapeutics Inc. has been awarded approximately $7.6 million in funding across two competitive grant programs from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to support Casma ...

Regenerative medicine company Bellaseno GmbH is accelerating development of its absorbable breast scaffold, with a pivotal Australian trial recruiting faster than expected and a newly announced ...

The use of organoids in preclinical research has reached a tipping point, with U.S. FDA approval of the first drug to enter clinical trials on the basis of efficacy data derived only from these ...