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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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The extension will give the FDA sufficient time to look into the drug for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
While COVID-19 appears to be battling back in cold-weather states in the U.S. and parts of Europe, researchers continue to study vaccine efficacy and new approaches to dosing. Here’s a look.
BioNTech is on the Fast Track. This morning, the company announced it received Fast Track Designation from the U.S. Food and Drug Administration for its cancer immunotherapy candidate.
A recent study has highlighted the need for more stringent Phase II trial protocols on the basis that over 80% of candidate oncology treatments that go into Phase III failed to achieve OS goals.
Scientists from Stanford University investigated the effectiveness of an oral tablet flu vaccine called VXA-A1.1 by Vaxart, which uses cellular correlates of protection.
Biopharma and life sciences companies strengthen their leadership teams and boards with these Movers & Shakers.
Monoclonal antibodies have proven to be an important therapeutic option in the ongoing battle against COVID-19.
Gilead Sciences announced it exercised its options to three of Arcus Biosciences’ programs. Two are anti-TIGIT molecules, domvanalimab and AB308, and the other is etrumadenant and quemliclustat.
Two weeks after Novartis announced it would sell its nearly one-third voting stake in next-door neighbor Roche, investors are chomping at the bit to find out how that almost $21 billion will be put to work.
Based on BridgeBio’s current pipeline of programs, this total amount will be sufficient to carry over 30 drug development and discovery programs well into 2024.