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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
Bristol Myers Squibb announced Friday that it is acquiring San Diego-based Turning Point Therapeutics in a deal totaling about $4.1 billion.
June is starting off with a number of important dates for the FDA, including an advisory committee meeting to discuss COVID-19 vaccines in children as young as six months.
BioSpace spoke with Payton Nyquvest, co-founder and CEO of Numinus about changing perceptions around psychedelic-assisted psychotherapy and the company’s work in this space.
Biopharma and life sciences companies strengthen their leadership teams and boards with these Movers & Shakers.
Centessa announced Thursday it is discontinuing the development of its lead asset, lixivaptan, for autosomal dominant polycystic kidney disease (ADPKD).
Bristol Myers Squibb’s Orencia and Johnson & Johnson’s Remicade improved survival rates for people hospitalized with COVID-19 according to a new report by the National Institutes of Health.
Tessera Therapeutics announced Thursday that ex-AbbVie executive Michael Severino, M.D. will take the helm of the young biotech.
With June just getting started, BMS and Sorrento are making new connections. Read on for announcements of these collaborations.
Monkeypox is not COVID-19, but both are viral diseases that are front-and-center in the world of public health and epidemiology. Here’s a look at the latest news on both outbreaks.
Top research stories, including gene regulation and longevity, a head-to-head comparison of COVID-19 vaccines, a newly discovered type of brain cell and more.