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FDA Drug Information

@FDA_Drug_Info

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Silver Spring
Joined July 2009
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@FDA_Drug_Info
FDA Drug Information
2 days
FDA invites you to attend a public workshop on the development of interchangeable biosimilar products. Register here for virtual or in-person participation:
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@FDA_Drug_Info
FDA Drug Information
3 days
FDA invites you to attend the interim public meeting for the BsUFA III Regulatory Science Pilot Program. Register here:
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@FDA_Drug_Info
FDA Drug Information
3 days
The CDER Center for Clinical Trial Innovation (C3TI) demonstration project on Bayesian methods is expanding its scope to include pre-specified primary analysis and trial monitoring, in addition to its previous focus on supplementary analysis. Learn more:
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@FDA_Drug_Info
FDA Drug Information
4 days
FDA releases final guidance on developing drugs for early Lyme disease. Guidance focuses on localized & disseminated disease; covers trial design, safety & efficacy; & aims to support drug development. Learn more: #LymeDisease #FDAGuidance.
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@FDA_Drug_Info
FDA Drug Information
10 days
FDA grants accelerated approval to a treatment for non-small cell lung cancer.
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@FDA_Drug_Info
FDA Drug Information
10 days
FDA grants accelerated approval to a treatment for relapsed or refractory multiple myeloma.
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@FDA_Drug_Info
FDA Drug Information
16 days
CDER released its 9th annual 2024 Drug Trials Snapshots report, which summarizes the demographic representation in the clinical trials that supported the 50 novel drugs approvals in 2024. 31,000 patients participated in these clinical trials. Learn more:
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@FDA_Drug_Info
FDA Drug Information
19 days
FDA grants accelerated approval to a treatment for EGFR-mutated non-small cell lung cancer.
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@FDA_Drug_Info
FDA Drug Information
24 days
FDA approves a treatment for relapsed or refractory follicular lymphoma.
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@FDA_Drug_Info
FDA Drug Information
24 days
FDA is still accepting applications until June 30, 2025, for the Rare Disease Endpoint Advancement (RDEA) Pilot Program which supports novel efficacy endpoint development for drugs that treat rare diseases. Learn more & submit your application today ➡️
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@FDA_Drug_Info
FDA Drug Information
29 days
FDA announces the availability of the 2024 Office of Clinical Pharmacology Annual Report:
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@FDA_Drug_Info
FDA Drug Information
30 days
#FDA approves a treatment for adults with resectable locally advanced head and neck squamous cell cancer whose tumors express PD-L1.
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@FDA_Drug_Info
FDA Drug Information
1 month
FDA approves a treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
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@FDA_Drug_Info
FDA Drug Information
1 month
FDA approves a treatment for ROS1-positive non-small cell lung cancer.
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@FDA_Drug_Info
FDA Drug Information
1 month
RSV is a common respiratory virus that spreads in the fall and winter.
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@FDA_Drug_Info
FDA Drug Information
1 month
FDA approves Enflonsia (clesrovimab), a single-dose monoclonal antibody indicated to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season.
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@FDA_Drug_Info
FDA Drug Information
1 month
FDA proposes requirements for minor dosage form changes for certain OTC monograph drugs from tablets/capsules to chewable tablets, orally disintegrating tablets, or films. Draft guidance also released. Public comments open. #FDA #OTCDrugs
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@FDA_Drug_Info
FDA Drug Information
2 months
Just in – A new paper detailing the history and evolution of FDA’s “Orange Book” publication—the foundational resource for drug approvals, patents, exclusivities, and more. Authors discuss key changes to this essential pharmaceutical industry resource.
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@FDA_Drug_Info
FDA Drug Information
2 months
The FDA plays an important role in #clinicaltrials by reviewing protocols, monitoring safety, inspecting sites, evaluating data, & more. The collective effort of participants, researchers, healthcare teams, and regulators helps bring therapies to patients.
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@FDA_Drug_Info
FDA Drug Information
2 months
Today, #FDA releases 48 new PSGs to facilitate generic drug development, including treatments for postpartum depression, lung disease and Duchenne muscular dystrophy. This effort aims to improve access to safe, effective, and affordable medications.
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