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
A preprint in bioRxiv from Penn State showed SARS-CoV-2 was detected in 33% (94) of the 283 white-tailed deer tested in Iowa between November 23, 2020 and January 10, 2021.
Positive data from an ongoing Phase Ib study has impressed investors in Aptevo Therapeutics.
Vaccibody has changed its name to Nykode Therapeutics. “Nykode” means “new code,” which plays on the potential of the company to generate novel codes and innovative patient therapies.
Tonix expects to begin enrollment in the trial for TNX-1900, an intranasal potentiated oxytocin, during the second half of 2022.
The U.S. FDA is making up for Covid-lost time this year, doubling the goal for FY 2021 domestic surveillance inspections for food and medical manufacturing facilities.
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones from this week.
Shares of Aadi Bioscience were up more than 25% in premarket trading after announcing the FDA greenlit its treatment for a rare and aggressive form of cancer that disproportionately affects women.
The U.S. CDC has issued new travel warnings as surges of COVID-19 continue throughout the country and the world. For that and other COVID-19 news, read below.
After months of ongoing testimony from various whistleblowers and investors, Elizabeth Holmes, Theranos founder and CEO, has finally taken the witness stand in her fraud trial.
It’s been a busy week so far, with new discovery facilities launched in the biotech space.