With all the focus of late on the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP), the FDA’s 30-plus advisory committees have been flying under the radar, especially since many of them haven’t met for a few years now.
As robotic-assisted surgery platforms increasingly demonstrate that they can perform telesurgery safely, the question now is how soon remote operations will become part of routine clinical care. Eduardo Fonseca, CEO of Xcath Robotics Inc., reckons that within a decade the company’s Iris Surgical Robotic System could be in widespread use.
Just five months after raising a $70 million series A round, newly launched Excellergy Inc. agreed to a $2 billion M&A transaction that would bring its trifunctional allergic effector cell response inhibitors (ECRIs) to Novartis AG.
In a win for the rare disease space, the U.S. FDA granted accelerated approval for Rocket Pharmaceuticals Inc.’s Kresladi (marnetegragene autotemcel) as the first gene therapy option for treating severe leukocyte adhesion deficiency-I (LAD-I), an ultrarare genetic immune disorder characterized by an immunodeficiency predisposing those affected to recurrent and fatal infections.
Medtronic plc has lowered its fiscal year 2026 earnings per share (EPS) guidance by 12 cents on the back of factors relating to its diabetes subsidiary, Minimed Group Inc., which recently completed its IPO.
Endogenex Inc. has raised $50 million in an extension to its series C financing round to fund the completion of its pivotal Recet clinical study, which is evaluating the use of the company’s non-thermal pulsed electric field system for remodeling the duodenal tissue in adults with type 2 diabetes. The new capital will also be used to support the company's regulatory pathway toward U.S. FDA approval.
Apparently put off by data with a higher dose, investors in Wave Life Sciences Inc. backed away after the company rolled out data from the phase I portion of its first-in-human Inlight trial evaluating 250 mg of WVE-007, an INHBE GalNAc-siRNA prospect, in otherwise healthy overweight or obese adults.
After previous setbacks with the program, investors largely brushed aside ocular-focused Kodiak Sciences Inc.’s anticipated phase III Glow2 data of tarcocimab tedromer in diabetic retinopathy (DR), so the positive top-line superiority results revealed March 26 caught many by surprise as it sets the company up for an accelerated multi-indication BLA submission.
A member of the CDC’s Advisory Committee on Immunization Practices (ACIP), physician and biochemist Robert Malone, who a judge earlier this week suggested lacked vaccine-related experience, wrote March 19 on X that the committee “has been disbanded.” Nearly six hours later, he followed up, saying it was a “miscommunication.”
The U.S. FDA has issued a final order to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from class III to class II, with special controls required.
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