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.
FROM OUR EDITORS
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
ARO-HSD will be evaluated in a Phase I/II trial that will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of its ability to target HSD17B13 as a treatment for NASH.
If you are wondering what the butterfly effect is and how it affects COVID-19 patients, you have come to the right place. Here is everything you need to know.
Before going for pharmaceutical jobs interviews, you should be prepared to give the best answers possible. Here are six questions you should be ready for.
Even before the drug’s approval on June 7, there were cases of amyloid-related imaging abnormalities (ARIA-E), or cerebral edema, observed in the trials.
Twist Bioscience snapped up in vivo antibody discovery company Abveris Inc. in a deal valued at up to $190 million. The acquisition is expected to bolster Twist’s biopharma antibody capabilities.
Under the strategic collaboration, Neurocrine Biosciences and Sosei Group Corporation will develop and commercialize novel muscarinic receptor agonists to treat the said illnesses.
After indicating it might entertain a sale, Novartis may receive an offer from investment group EQT and the Struengmann family for its generic unit Sandoz.
News on COVID-19 vaccine developments and disease studies continue to deliver highs and lows. Here are some of the more recent happenings.
The FDA has granted Cambridge-based bluebird Bio a Priority Review of its Biologics License Application for betibeglogene autotemcel (beti-cel).
Connect Biopharma shares plummeted 55% despite reported positive topline data from its Phase II trial of CBP-201 for adults with moderate-to-severe atopic dermatitis.