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. Read More
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.
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
Microglia play a central role in the neuroinflammation associated with Alzheimer’s disease (AD). At the 20th International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD), scientists focused on TREM2, a microglial receptor that regulates immune responses, exploring new ways to address neuroinflammation. Read More
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. Read More
BioWorld tracked 152 clinical trial readouts across phases I through III in February 2026, up from 144 in January but down from 215 in December. Of those, 20 phase III trials reported positive results, while one failed to meet key endpoints. By phase, February’s updates consisted of 50 from phase I, 46 from phase II and 57 from phase III. Read More
New hires and promotions in the biopharma and med-tech industries, including: Averna, Braveheart, Concert AI, Crossject, Faron, Geron, Humacyte, Ligand, Plus, Prokidney, Rani, Sironax. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Alzamend Neuro, GH Research, Kodiak, Novocure, Rubedo, Spinogenix, Wave Life. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Brainsway, Clemann, Eos Senolytix, Hookipa, Lifeward, Lunai, Microbot, Neurolief, Neotrail, Oramed, Pulmatrix. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: 3D Systems, Agilent, Corcept, Deciphera, Deepecho, Denali, Fennec, GC Biopharma, Invivoscribe, Ono, Rhythm, Royal Philips, Soligenix. Read More
