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Panel to Discuss Non-invasive Ocular Pump

[ Price : $8.95]

FDA asks the Ophthalmic Devices Panel to discuss safety and other issues related to the Balance Ophthalmics FSYX ocular pump to lo...

Key Patient Long Covid Meeting Themes

[ Price : $8.95]

FDA reports the key themes that emerged from a 3/2023 virtual meeting with patients and caregivers on long Covid.

Disease Awareness Ads Can Confuse: FDA Study

[ Price : $8.95]

CDER Office of Prescription Drug Promotion research demonstrates that consumers may be confused and conflate product benefits and ...

Digital Health Research Grants Available

[ Price : $8.95]

FDA solicits applications for grants to explore the role of digital health technologies in evaluating new drugs.

FDA to Make Compounding Difficulty Lists

[ Price : $8.95]

FDA proposes to evaluate drugs and categories of drugs that present demonstrable difficulties for compounding and place three cate...

Bipartisan Bill to Shore Up Emergency APIs

[ Price : $8.95]

Two U.S. House lawmakers introduce a bipartisan bill to create an emergency supply of active pharmaceutical ingredients (APIs) use...

FDA Withdraws NDA/NADA for Helium

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of an Air Products and Chemicals NDA and new animal drug application for medical g...

Renal PK Study Guidance

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FDA publishes a guidance to assist in the design and analysis of studies assessing the influence of impaired renal function on an ...

Iclusig Accelerated Approval for Leukemia

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FDA grants Takeda Pharmaceutical accelerated approval for Iclusig (ponatinib) for use with chemotherapy in adult patients with new...

FDA Accepts BLA Resubmission for Lymphir

[ Price : $8.95]

FDA accepts for review a Citius Pharmaceuticals BLA resubmission for Lymphir (denileukin diftitox), an interleukin-2-based immunot...