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Home » Topics » Regulatory

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FDA approved icons and medical professional

FDA clears Agilemd’s AI-driven clinical deterioration tool

June 27, 2024
By Annette Boyle
Agilemd Inc. received U.S. FDA clearance for its Ecart clinical deterioration suite, an artificial intelligence-powered software as a medical device that uses a machine learning algorithm to continuously evaluate the risk of a hospitalized patient’s death or transfer to intensive care based on 97 real-time variables.
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U.S. FDA headquarters

US FDA disinclined to grant waivers for clinical trial diversity plans

June 27, 2024
By Mark McCarty
The U.S. FDA reissued a 2022 draft guidance for clinical trial diversity at the behest of legislation from Congress, ballooning the previous nine-page draft to 23 pages.
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Alivecor 12lead

Alivecor’s 12-lead, AI-powered ECG system wins FDA clearance

June 27, 2024
By Holland Johnson
After spending years battling with Apple Inc. over the consumer heart monitoring market Alivecor Inc. is hoping to bring its technology to the professional health care market with its new device, which recently received clearance from the U.S. FDA.
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Close up of man wearing nebulizer

Verona’s Ohtuvayre for COPD secures US FDA nod

June 27, 2024
By Karen Carey
The U.S. FDA granted approval of Verona Pharma plc’s ensifentrine on its PDUFA date of June 26, giving the chronic obstructive pulmonary disease (COPD) community its first new mechanistic option in a decade. The drug, branded Ohtuvayre, is also the first inhaled nonsteroidal therapy to treat a respiratory disease that combines both a bronchodilator and anti-inflammatory mechanism into one molecule. It is indicated for the maintenance treatment of COPD, which Verona said allows for broad use.
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3D illustration of the cross-section of skin layers with atopic dermatitis
Dermatologic

Concerto Bioscience’s live biotherapeutic product gains IND clearance for atopic dermatitis

June 27, 2024
Concerto Bioscience Inc. has received FDA clearance of its IND application to initiate a first-in-human phase I trial of Ensemble No.2 (ENS-002), an investigational live biotherapeutic product to treat atopic dermatitis.
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Art concept for molecular glue degredation
Gastrointestinal

Monte Rosa Therapeutics files IND application for molecular glue degrader MRT-6160

June 27, 2024
Monte Rosa Therapeutics Inc. has submitted an IND application to the FDA for MRT-6160, a highly selective and orally bioavailable molecular glue degrader directed against VAV1 in development for systemic and neurological autoimmune diseases.
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Gastrointestinal

Resolution Therapeutics’ engineered macrophage cell therapy to enter clinic for decompensated liver cirrhosis

June 27, 2024
Resolution Therapeutics Ltd. has received approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a phase I/II study of its lead candidate RTX-001 in patients with decompensated liver cirrhosis.
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Daiichi, Merck’s HER3-DXd gets CRL for lung cancer

June 27, 2024
By Karen Carey
Partners Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. received a complete response letter (CRL) from the U.S. FDA for their first-in-class HER3-directed antibody-drug conjugate HER3-DXd (patritumab deruxtecan) to treat patients with locally advanced or metastatic EGFR-mutated non-small-cell lung cancer.
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Fed Circuit resuscitates skinny label infringement challenge

June 26, 2024
By Mari Serebrov
In reviving another case involving drug label carveouts, the U.S. Court of Appeals for the Federal Circuit insisted that its June 25 decision in Amarin Pharma Inc. v. Hikma Pharmaceuticals plc will not kill so-called skinny labels that allow generics to come to market when some of the brand’s indications still have patent protection.
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Fallopian tubes, ovaries and uterus

Femasys receives CE mark for four women’s health products

June 26, 2024
By Shani Alexander
Femasys Inc. received CE mark for four women’s health products – Femaseed, Femvue, Femcerv and Femcath – after obtaining certification under the EU Medical Device Regulation. This allows the company to expand its market reach and it will now focus on delivering its innovative solutions for women’s reproductive health within the EU.
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