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The FDA approved AstraZeneca’s Imfinzi plus with gemcitabine-cisplatin chemotherapy as the first immunotherapy for adult patients with locally advanced or metastatic biliary tract cancer.
Industry observers say the Inflation Reduction Act of 2022 could affect the direction of research, and some fear it may lead to further government forays into price control.
The FDA provided briefing documents ahead of Amylyx’s rare second adcomm for AMX0035, an investigational treatment for ALS. The regulator does not appear to be convinced.
The U.S. Food and Drug Administration had a busy week leading up to the Labor Day holiday. Here’s a look at the agency’s recent activities.
A new report estimates that if cannabis was to be legalized across the United States, it could cut into pharmaceutical sales by billions of dollars.
The best thing a professional can do when considering a position at the FDA is weigh the pros and cons. To help, we’ve created a guide to working at the FDA, with benefits, challenges and tips.
Boehringer announced that the FDA approved Spevigo for generalized pustular psoriasis flares in adults, the first drug approved for this indication.
Researchers found that inhibiting a key metabolic enzyme kills melanoma cells and halts tumor growth, opening the door for a new class of drugs to treat melanoma.
Immusoft is heading into the clinic with what it claims is the first engineered B cell gene therapy cleared for in-human study, the company announced Thursday.
Finch announced that it is slashing its headcount by around 37% and suspending its planned Phase I study in autism a week after Takeda withdrew from its multi-year collaboration.
The Administrative Law Judge overseeing the FTC’s challenge of Illumina’s acquisition of Grail rejected the regulator’s anti-competition argument, Illumina announced Thursday.
It’s been a busy week for research on rare diseases, with several clinical trials from AnaptysBio, Regenxbio, Sangamo and more posting results from ongoing activities.
