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FDA Sends Warning to Companies for Offering Unapproved Umbilical Cord Blood Products americanpharmaceuticalreview
December 12, 2019
The U.S. Food and Drug Administration (FDA) has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, of Yorba Linda, California, and their presidents and chief executive officers ...
Consumers told not to use drugs recalled from Basic Reset and Biogenyx europeanpharmaceuticalreview
December 12, 2019
The FDA has informed consumers not to use drugs recalled from Basic Reset and Biogenyx following consent decree for federal violations.
FDA Approves Avsola (infliximab-axxq), a Biosimilar to Remicade drugs
December 11, 2019
Amgen announced that the U.S. Food and Drug Administration (FDA) has approved Avsola (infliximab-axxq) for all approved indications of the reference product, Remicade® (infliximab) ...
ViiV Healthcare seeks FDA approval for fostemsavir to treat HIV-1 infection pharmaceutical-business-review
December 11, 2019
ViiV Healthcare is seeking approval from the US Food and Drug Administration (FDA) for its fostemsavir to treat HIV-1 infection.
Meitheal Pharmaceuticals announces FDA approval of Enoxaparin Sodium Injection, USP pharmaceutical-business-review
December 11, 2019
Meitheal Pharmaceuticals, a fully integrated generic injectables company today announced that the US Food and Drug Administration (FDA) has approved Enoxaparin Sodium Injection, USP ...
FDA Approves AVSOLA americanpharmaceuticalreview
December 11, 2019
Amgen announced the U.S. Food and Drug Administration (FDA) has approved AVSOLA™ (infliximab-axxq) for all approved indications of the reference product, Remicade® (infliximab)
Parexel Adds Experts to Regulatory Consulting Group ContractPharma
December 11, 2019
Four new hires from U.S. FDA and MHRA will serve as technical vice presidents.
Vivera Pharma, Parexel Ink Clinical Services Agreement ContractPharma
December 11, 2019
Parexel to conduct Phase I study to evaluate the bioavailability of TABMELT technology and provide regulatory support for Vivera's IND.
FDA Requires Additional Testing of Ranitidine, Nizatidine americanpharmaceuticalreview
December 10, 2019
Over the past several weeks, the U.S. Food and Drug Association (FDA) has communicated about the detection of an impurity known as N-nitrosodimethylamine (NDMA) in ...
FDA approves new line of methotrexate products for rheumatoid arthritis europeanpharmaceuticalreview
December 10, 2019
RediTrex, a new line of methotrexate products, has been approved by the FDA for the treatment of patients with rheumatoid arthritis.

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