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FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
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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.
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In the ongoing proxy battle between London-based Mereo BioPharma Group and Rubric Capital Management, Mereo outlined the outcome of the most recent negotiations, which Rubric rejected.
MassBioEd partners with developers in Boston to train and employ more workers in a burgeoning Genetown life sciences industry desperate for skilled labor. Meanwhile, Biogen clears real-estate space.
Daiichi Sankyo won approval in Japan for Ezharmia, making it the first dual inhibitor of EZH1 and EZH2 to receive regulatory approval for ATL.
Equillium, 9 Meters Biopharma and ABVC Biopharma have something to say about lupus, short bowel syndrome and ADHD.
BioSpace spoke with Saundra Pelletier, CEO of Evofem Biosciences, to discuss the realities of being a woman in the life sciences and find out the career moves that propelled her forward.
In an 8-4 vote, the FDA’s Oncologic Drugs Advisory Committee Roster voted against the benefit-risk profile of Secura Bio’s P13K inhibitor Copiktra (duvelisib).
The announcement follows a subgroup analysis of the Phase III SOLO3 trial which showed patients treated with Lynparza saw a 33% greater risk of death than controls who received standard chemotherapy.
Seagen and LAVA Therapeutics inked a licensing deal for LAVA’s Gammabody platform for solid tumors, which can potentially exceed $700 million.
The FDA might only have two PDUFA dates on the calendar this week, but all eyes in the neurodegenerative disease community will be on the first one: Amylyx’s AMX0035 for ALS.
September 24 is World Cancer Research Day, and September is Childhood Cancer Awareness Month. BioSpace spoke with leaders from three companies tackling pediatric glioma.