News
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
FEATURED STORIES
Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
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Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
BrainStorm Cell Therapeutics announced the publication of peer-reviewed data from a Phase II trial in progressive multiple sclerosis Thursday showing “preliminary evidence of efficacy.”
Biopharma and life science companies added changes to their leadership teams this week, with Cara Therapeutics, SOTIO Biotech, Agenus, and more filling several C-suite positions.
The Sept. 30 deadline for Congress to reauthorize the FDA’s prescription drug user fee is looming, while advocates and detractors are debating the merits of the funding source.
With a distinct take on CRISPR, Carver Biosciences secured seed financing to support the development of RNA-targeting gene therapies aimed at RNA-based respiratory infectious diseases.
There’s a new collaboration in the Parkinson’s disease development space, Cardiff Oncology kicks off a mid-phase study in colorectal cancer and Ocugen published a new review of COVAXIN.
Two days after unveiling an executive order to boost U.S. biomanufacturing, the White House unveiled plans that include $2 billion to support the initiative.
After reporting a failed clinical trial of ELX-02 for cystic fibrosis (CF), Eloxx Pharmaceuticals plans to shift its focus and use the drug to treat Alport syndrome, a rare kidney disease.
Novartis confirmed it is the subject of an investigation by the Swiss Competition Commission over possible unlawful patent use.
Pfizer is leveraging its funding and experience with vaccines, developing its meningococcal, flu, and RSV vaccines. It also announced its venture investment in Nimbus Therapeutics.
Gala Therapeutics and Galaxy Medical will be folded into Galvanize Therapeutics to continue to develop their electric pulse therapies for bronchitis, cardiac arrhythmias and solid tumors.