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Novartis said it will work diligently with the FDA to resolve the partial clinical hold and resume the study.
Makena has been approved to decrease preterm birth in pregnant women with a previous spontaneous preterm birth.
Arcutis Also Announces Enrollment of Last Patient in 52-Week Long-term Safety Study of ARQ-151 Cream as a Potential Topical Treatment for Plaque Psoriasis
GeoVax Vaccine To Be Used in a Phase 1 Trial of Genetically Modified Autologous Cell Therapy for HIV
GeoVax Labs, Inc. announced its participation in a planned clinical trial led by researchers at American Gene Technologies, to develop a therapy aimed at eliminating HIV from infected people..
Although the clinical trial news last week was dominated by the stunning reversal of Biogen and Eisai’s clinical trials of aducanumab for Alzheimer’s disease, there was plenty of other trial news. Here’s a look.
In its announcement on Thursday, the FDA said its preliminary tests of alternative antacid treatments such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) currently show no NDMA at this time based on testing.
This morning’s approval from the U.S. Food and Drug Administration marks the 11th therapeutic indication for Botox, a product tent pole for Ireland-based Allergan.
GlaxoSmithKline’s PARP inhibitor Zejula has been approved for wider use in some cancers.
Porton Biopharma Ltd has announced that it has signed a modification to its contract with the US National Institute of Health’s National Institute of Allergy and Infectious Diseases to advance a next generation intra-nasal anthrax vaccine into the clinical-trial phase.
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