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Home » Topics » Regulatory

Regulatory
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Moon Surgical Maestro

Moon Surgical gets FDA clearance for surgical robotic system

June 7, 2024
By Shani Alexander
Moon Surgical SAS recently received U.S. FDA clearance for the commercial version of its Maestro surgical robotic system for laparoscopic procedures. The greenlight is “pretty massive” for the company as it will allow the robotic platform to be rolled out in the U.S., to help enhance the surgeon’s performance while carrying out procedures, Anne Osdoit, CEO of Moon Surgical, told BioWorld.
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Coins and financial paperwork

Takeout interest continues for Vanda: Cycle offers $8 a share

June 6, 2024
By Karen Carey
Washington-based Vanda Pharmaceuticals Inc. has faced a challenging few years involving a federal lawsuit against the U.S. FDA, patent infringement litigation, increasing generic competition and dwindling sales, as well as a complete response letter nixing plans to expand its melatonin receptor agonist Hetlioz (tasimelteon) into insomnia, yet it has recently received a higher, unsolicited acquisition offer of $466 million from a second company, Cycle Pharmaceuticals Ltd.
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No surprises for upcoming donanemab adcom

June 6, 2024
By Mari Serebrov
Although the U.S. FDA unexpectedly sprang the news on Eli Lilly and Co. that it would hold an advisory committee meeting on the BLA for the company’s Alzheimer’s disease drug, donanemab, the agency’s briefing document for the June 10 meeting doesn’t appear to hold any surprises.
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Canadian flag, gavel

Canadian firms take center stage in latest batch of FDA warnings

June 6, 2024
By Mark McCarty
Medical device manufacturers based in China may feel the FDA has a bullseye on their backs, but two firms located in Canada were the subjects of recently posted FDA warning letters.
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Brain illustrated with pills

Adcom a ‘learning experience’ for psychedelic development

June 5, 2024
By Mari Serebrov
The discussion that preceded the June 4 U.S. FDA advisory committee vote against the approval of Lykos Therapeutics Inc.’s midomafetamine as a treatment for post-traumatic stress disorder could shine some light on the way forward for other sponsors developing psychedelics for approved medical use.
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Genetic Signature GI Parasite Detection Kit

Genetic Signatures launching GI parasite test in US following clearance

June 5, 2024
By Tamra Sami
Molecular diagnostics company Genetic Signatures Ltd. is gearing up to launch its Easyscreen gastrointestinal parasite detection kit in the U.S. following its first FDA 510(k) clearance.
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Coins, cash, calculator, pills

Illumina’s spinoff of Grail not necessarily the final chapter

June 5, 2024
By Mark McCarty
The saga of Illumina Inc.’s attempt to reacquire Grail Inc., seems to have come to an end with a capitulation to market regulatory authorities, but Illumina has chosen to spin off Menlo Park, Calif,-based Grail rather than sell the company outright.
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Immuno-oncology

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical’s FZ-AD005 receives IND clearance in China

June 5, 2024
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co. Ltd. has received IND clearance in China by the National Medical Products Administration (NMPA) to conduct a phase I trial of its antibody-drug conjugate (ADC) FZ-AD005 for advanced solid tumors.
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Red blood cells on blue background
Hematologic

Be Biopharma’s BE-101 awarded US orphan drug designation for hemophilia B

June 5, 2024
The FDA has granted orphan drug designation to Be Biopharma Inc.’s BE-101, a novel engineered B-cell medicine being developed for the treatment of hemophilia B.
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Illustration of lung cancer, DNA double helix
Immuno-oncology

Pierre Fabre files IND application for PFL-002 for solid tumors with MET alterations

June 5, 2024
Pierre Fabre Laboratories (Pierre Fabre SA) has filed an IND application to the FDA to initiate a first-in-human trial with PFL-002 (VERT-002) for solid tumors, including non-small-cell lung cancer (NSCLC).
Read More
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