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News
New drug application
Sep 11, 2019
United Therapeutics Announces FDA Acceptance Of Trevyent New Drug Application For Review
Aug 29, 2019
Luye Pharma First Half of 2019 Results: Strong Revenue Growth and Substantial Development of R&D Product Pipelines
Aug 28, 2019
Veterinary Drug Approval Process and FDA Regulatory Course: Chicago, IL, United States - December 5-6, 2019
Aug 28, 2019
Two Day Veterinary Drug Approval Process and FDA Regulatory Oversight Seminar: Kansas City, United States - September 26-27, 2019
Aug 21, 2019
SAAMnow Holding Fall Workshop on 505(b)(2)s
Aug 19, 2019
PharmaMar will submit NDA for lurbinectedin under accelerated approval in SCLC in the USA
Aug 13, 2019
Windtree Announces FDA Fast Track Designation for Istaroxime
Aug 07, 2019
Blueprint Medicines Announces FDA Acceptance of New Drug Application for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST
Aug 05, 2019
Foamix Submits New Drug Application to U.S. FDA for FMX103 for the Treatment of Moderate-to-Severe Papulopustular Rosacea
Jul 03, 2019
FDA Clears Path For The Continuing Review Of Lannett Company's New Drug Application
May 31, 2019
Two Day FDA Drug Approval Process Seminar: FDA Requirements for Submission of NDAs, ANDAs and 505(b)(2) - London, United Kingdom - September 19-20, 2019
May 15, 2019
Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings (Philadelphia, PA, United States - June 20-21, 2019)
May 14, 2019
Lipocine Announces TLANDO(TM) NDA PDUFA Action Date of November 9, 2019
Apr 16, 2019
Aquestive Therapeutics Announces U.S. Food and Drug Administration (FDA) Acceptance of New Drug Application for Riluzole Oral Film for Treatment of ALS
Mar 29, 2019
Foresee Pharmaceuticals Announces Submission of NDA for FDA Approval of LMIS 50 mg
Mar 27, 2019
Blueprint Medicines Announces Accelerated Regulatory Submission Plans and Recent Clinical Progress
Mar 26, 2019
Chinese Regulatory Authority [NMPA] Approves IND Application of Oramed's Oral Insulin Capsules
Mar 08, 2019
Nanopharmaceutical Drugs Market, 2026 - Increase in Number of Abbreviated New Drug Application (ANDA), Biologics License Application (BLA) Approvals: Closing the Gap for Generic Nanomedicines
Feb 27, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D. as prepared for oral testimony before the U.S. House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Committee on Appropriations
Feb 25, 2019
FDA In Brief: To improve drug safety and effectiveness, FDA issues new guidelines on evaluating the absorption of drugs in the body, including the effect of eating certain foods on drug efficacy
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