Hologic Inc.’s focus on women’s health is looking like a brilliant move as the company lands U.S. FDA clearance for its Genius digital diagnostics system with the Genius cervical artificial intelligence algorithm, making it the first digital cytology system with clearance, the company said.
Edwards Lifesciences Corp. received some good news with the earlier-than-expected U.S. FDA approval of its Evoque tricuspid valve replacement system. The company beat out rival Abbott Laboratories for the honor of being the first transcatheter therapy to receive FDA approval.
In a historic first, the U.S. Centers for Medicare & Medicaid Services (CMS) sent out its opening offers Feb. 1 for the first round of prescription drug price negotiations.
The U.S. Federal Trade Commission (FTC) has drawn blistering criticism over the past couple of years over its handling of merger and acquisition (M&A) activity, criticism that was anything but blunted in a Jan. 31 webinar on the subject.
Cognito Therapeutics Inc. closed a $35 million extension to the series B fundraising round it started in 2023, bringing the total for the round to $108 million and the total funding to date to $128 million. Cognito is developing Spectris, a wearable medical device that provides visual and auditory stimulation for the treatment of Alzheimer’s disease and other neurological disorders.
Jaguar Gene Therapy LLC’s IND application for JAG-201, a gene therapy for a genetic form of autism spectrum disorder (ASD) and Phelan-McDermid syndrome (PMS; 22q13.3 deletion syndrome), has been cleared by the FDA.
23andme Holding Co. has received FDA clearance of its IND application for 23ME-01473 (‘1473), a dual mechanism antibody and natural killer (NK) cell activator intended to treat cancer.
Newly approved gene therapies targeting sickle cell disease will be the first focus of the U.S. Centers for Medicare & Medicaid Services’ (CMS) Cell and Gene Therapy Access Model, the agency said Jan. 30.
The U.S. SEC denied a petition asking it to amend its 50-year-old no-admit/no-deny settlement policy that slaps a perpetual gag on parties that opt to resolve SEC allegations through settlements rather than in court.
The EU’s proposed update of its pharmaceutical legislation will break the model of small companies acting as the vehicle for translating Europe’s rich research base for onward development by pharma, according to an analysis looking specifically at the impact the new rules would have on the biotech sector.
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