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Lilly Scraps Diabetes Drug After Disappointing Data

[ Price : $8.95]

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14 Drug Products Not Withdrawn for S&E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Federal Register Notice: FDA determines that 14 drug products were not withdrawn from sale for reasons of safety or effectiveness.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Draft Guidance on Best Practices for IND Sponsor/FDA Talks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FDA posts a draft guidance on Best Practices for Communication Between IND Sponsors and FDA During Drug Development.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-...

Trevena Given Fast Track for Novel Pain Drug

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FDA grants Trevena a fast track designation for oliceridine (TRV130) for managing moderate-to-severe acute pain.

Sun Pharma Gains FDA OK for Generic Gleevec

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FDA approves a Sun Pharmaceutical Industries ANDA for generic versions of Novartis chronic myeloid leukemia treatment Gleevec (ima...

FDA Alert Warns About Lipo Escultura

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An FDA safety alert says Lipo Escultura Corp. (Brooklyn, NY) is recalling all Lipo Escultura dietary supplement products because, ...

eCopy Program Submission Guidance

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FDA issues an updated final guidance on eCopy submission standards for medical devices.