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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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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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See inside for BioSpace’s compilation of the five biggest M&A deals of 2022.
In a comparison trial, BeiGene’s Brukinsa bested Janssen’s Imbruvica in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).
Flagship Pioneering has committed $50 million to Montai Health, a biotech that aims to develop therapies for chronic diseases using molecules already found in nature.
GSK bolstered its position in the oligonucleotide therapeutics space through a four-year collaboration with Wave Life Sciences valued at up to $3.3 billion.
An investigational mRNA cancer vaccine developed by Moderna and Merck reached its primary efficacy endpoint, inducing a clinically meaningful improvement in recurrence-free survival.
On the heels of positive Phase IIb data in plaque psoriasis, Takeda is acquiring both the therapy and Nimbus Lakshmi, a wholly owned subsidiary, in a potentially $6 billion deal.
Developed initially to deliver cytotoxic payloads to tumors, antibody therapeutics are evolving to provide new, next-generation conjugates and treat various diseases beyond cancer.
Mirati gets the green light from the FDA for its KRAS G12C-mutated lung cancer medication.
Seagen’s top-selling drug hit the mark in another major indication.
Clovis Oncology officially files for Chapter 11 bankruptcy.