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Adamis Pharma Resubmits NDA on Epinephrine Syringe

[ Price : $8.95]

Adamis Pharmaceuticals refiles an NDA for its epinephrine pre-filled syringe product for the emergency treatment of anaphylaxis.

Keep FDAs Hands Off Mobile Health Apps: Gottlieb

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American Enterprise Institute scholar and former FDA deputy commissioner Scott Gottlieb says the government should put a different...

Recent Advisory Committee Trends Detailed in Report

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A new report from Avalere Health on advisory committee trends finds that CDERs Cardiovascular and Renal Drugs Committee has recomm...

FDA Requires New Warning on Diabetes Drugs

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An FDA drug safety review leads to warnings being added to Type 2 diabetes drugs called sodium-glucose cotransporter-2 inhibitors ...

Lilly Scraps Diabetes Drug After Disappointing Data

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Eli Lilly decides to stop developing basal insulin peglispro, a potential treatment for Type 1 and Type 2 diabetes due to disappoi...

Amgen, Merck Collaborate on Combination Immunotherapies

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Amgen and Merck announce two cancer immunotherapy collaborations to support combination therapies in patients with diffuse large B...

14 Drug Products Not Withdrawn for S&E

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Federal Register Notice: FDA determines that 14 drug products were not withdrawn from sale for reasons of safety or effectiveness.

DoJ Subpoenas Mylan Over Doxycycline Pricing

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Mylan says one of its subsidiaries has received a subpoena from the Justice Departments Antitrust Division seeking information rel...

Draft Guidance on Best Practices for IND Sponsor/FDA Talks

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FDA posts a draft guidance on Best Practices for Communication Between IND Sponsors and FDA During Drug Development.

ADC Therapeutics IND for Antibody Drug Conjugate Cleared

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FDA clears an ADC Therapeutics IND to begin clinical trials with ADCT-402, a novel antibody drug conjugate targeting CD19, a cell-...