A regulatory plod that began in 2023 – and met with success in many other territories – at last crossed the U.S. FDA finish line when Novo Nordisk A/S secured approval of Awiqli (insulin icodec) injection 700 units/mL, the first and only once-weekly, long-acting basal insulin.
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.
The debated and ultimately stock-denting March 26 news from Wave Life Sciences Inc. pushed into the spotlight other firms working with INHBE and activin E.
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.
As expected, the EMA is recommending withdrawal of the mpox indication for Siga Technologies Inc.’s tecovirimat, whilst maintaining its approval as a treatment for smallpox, cowpox and adverse reactions to vaccinia vaccines.
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.
In a small Houston clinic, more than a decade ago, patients with advanced cancer were receiving treatments that used radioactive molecules to seek out tumors and destroy them from within using an approach that would eventually help reshape oncology.
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.
The BioWorld Drug Developers Index (BDDI) rose 6.42% in the first two months of 2026, outpacing both the Nasdaq Biotechnology Index (NBI) and the Dow Jones Industrial Average (DJIA).
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