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Home » Topics » Regulatory » FDA

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3d rendering of bispecific antibodies
Cardiovascular

Diagonal Therapeutics’ DIAG-723 designated orphan drug for hereditary hemorrhagic telangiectasia

June 19, 2025
No Comments
Diagonal Therapeutics Inc.’s DIAG-723 has been awarded orphan drug designation by the FDA for the treatment of hereditary hemorrhagic telangiectasia (HHT). Additionally, the EMA has provided a positive opinion for orphan drug designation, confirming that DIAG-723 meets the criteria for designation as an orphan drug in the E.U.
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Neuromark system

Rising demand spurs Neurent to open new Neuromark facility

June 18, 2025
By Shani Alexander
Amid rising demand for its Neuromark system, Neurent Medical Ltd. opened a new manufacturing facility in Ireland, which will serve as the central hub for the production of the device which treats chronic rhinitis.
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Jyong’s $20M US IPO to help refile NDA of urological botanic drug

June 18, 2025
By Marian (YoonJee) Chu
No Comments
Jyong Biotech Ltd. raised $20 million from its Nasdaq debut June 17 to advance a pipeline of botanical drugs targeting male urinary disorders. The New Taipei City, Taiwan-headquartered company’s shares began trading under the ticker MENS, and closed at $10.11 apiece at the bell, up 34.80% from its listing price of $7.50 per share. Shares had kicked up to $15 at opening, reaching double its offering price.
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BIO2025: John Crowley and Martin Makary

BIO 2025: Makary lays out FDA’s path, launches pilot review program

June 18, 2025
By Karen Carey
No Comments
On the same day that FDA Commissioner Martin Makary spoke in a fireside chat during the 2025 Biotechnology Innovation Organization’s International Convention, the agency unveiled a pilot commissioner’s national priority voucher program that will enable companies to receive a shortened FDA review time of one to two months.
Read More
Andembry

New orphan drug, CSL’s garadacimab, cleared for hereditary angioedema

June 18, 2025
By Karen Carey and Tamra Sami
No Comments
Following a complete response letter issued last October over CMC issues, CSL Behring LLC gained U.S. FDA approval June 16 of its humanized anti-factor XIIa monoclonal antibody, garadacimab (CSL-312), to prevent hereditary angioedema attacks.
Read More
Illustration of cancer tumor on pancreas
Immuno-oncology

Medicovestor’s Adobind MC-001 awarded US orphan drug designation

June 18, 2025
No Comments
Medicovestor Inc.’s Adobind MC-001 has been awarded orphan drug designation by the FDA for the treatment of pancreatic cancer. Adobind MC-001 is a chemoimmunotherapy antibody-drug conjugate that integrates proprietary enhancements to antibody structure, payload delivery and tumor engagement.
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Blood clot blocking a blood vessel

Inquis, Penumbra advance thrombectomy treatments

June 17, 2025
By Annette Boyle
Two med-tech companies focused on pulmonary embolism overcame their own blockages to commercialization this week. Inquis Medical Inc.’s Aventus thrombectomy system received U.S. FDA clearance for use in pulmonary embolism, an expanded indication, while Penumbra Inc. completed enrollment in the STORM-PE clinical trial of its Lightning Flash device.
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De novo key on keyboard

FDA releases another batch of regs for de novo decisions

June 17, 2025
By Mark McCarty
It appears the U.S. FDA believes it’s never a bad time to release regulatory information about devices granted market access via the de novo program. The agency recently posted information on the vintage de novo granted in 2018 to Imagen Technologies Inc. for the company’s Osteo Detect algorithm.
Read More

Nextcure stock drops near 30% on $745M ADC deal with Simcere

June 17, 2025
By Marian (YoonJee) Chu
No Comments
Shares of Nextcure Inc. (NASDAQ:NXTC) dropped 26.27% on news of a potential $745 million partnership with Simcere Zaiming for Simcere’s cadherin-6 antibody-drug conjugate (ADC) candidate. Shares ended at 50 cents apiece June 16.
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Tape measure, apple on scale
Endocrine/metabolic

MBX Biosciences files IND application for MBX-4291 for obesity

June 17, 2025
No Comments
MBX Biosciences Inc. has submitted an IND application to the FDA for MBX-4291, a long-acting glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) receptor co-agonist prodrug for the treatment of obesity.
Read More
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