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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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Under the terms of their merger agreement, the deal can be terminated at any time. Know what happened between Valo Health & Khosla Ventures before the merger.
The decision comes after the Phase II MOONSONG trial on the oral antiviral pill AT-527 failed to meet the primary endpoint in October.
Iterum Therapeutics will head back into the clinic to meet regulatory requirements to refile a New Drug Application for oral sulopenem.
The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a negative trend vote on the company’s Marketing Authorization Application for Aduhelm.
While COVID-19 appears to be surging again in the U.S. and Europe, the government is spending billions to acquire antibody and antiviral therapies and edging toward vaccination boosters.
This week, Berkshire announced that it has scaled back those investments, and completely eliminated its stake in Merck.
Pfizer is initiating an external search for a new CFO with Frank D’Amelio agreeing to remain with the company through the transition.
Chroma Medicine debuted Wednesday morning with $125 million in seed and Series A funding.
Earlier studies suggest a correlation between COVID-19 vaccines and menstrual changes. A new study says otherwise.
AcelRx Pharmaceuticals and Kala Pharmaceuticals both shared acquisition news on Monday. Here’s a closer look at each of the acquisition announcements.