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Trodelvy from Immunomedics gets US FDA orphan drug designation for glioblastoma
expresspharma
October 14, 2020
Trodelvy has shown encouraging activity in an early-stage study in brain cancers, including partial responses in small cohorts of patients with brain metastasis from breast cancer and recurrent glioblastoma, informed the company.
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US FDA grants orphan drug designation to oNKord from Glycostem for multiple myeloma
expresspharma
October 14, 2020
The designation will provide Glycostem with eligibility for seven years of market exclusivity and clear FDA guidance on specific aspects of development for rare diseases.
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FDA Approves First Commercial Drug Manufactured via Ajinomoto AJIPHASE Technology
americanpharmaceuticalreview
October 12, 2020
Ajinomoto Bio-Pharma Services announced the U.S. Food and Drug Administration (FDA) has approved the first commercial drug manufactured via Ajinomoto Bio-Pharma’s proprietary AJIPHASE® production process.
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FDA Finalizes Guidance to Encourage Development of Novel Medicines to Treat Opioid Use Disorder
americanpharmaceuticalreview
October 12, 2020
The U.S. Food and Drug Administration (FDA) issued a final guidance, “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment” which is intended to help companies develop drugs to treat OUD and addresses the clinical ...
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Haemonetics Receives FDA Clearance for NexSys PCS with Persona Technology
americanpharmaceuticalreview
October 12, 2020
Haemonetics has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NexSys PCS® system with Persona™ technology.
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BioMarin Receives FDA Fast Track Designation for PKU Investigational Gene Therapy
americanpharmaceuticalreview
October 12, 2020
BioMarin Pharmaceutical announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BMN 307, an investigational gene therapy for the treatment of individuals with PKU.
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Nephron Receives Warning Letter from FDA
americanpharmaceuticalreview
October 12, 2020
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Nephron Pharmaceuticals Corporation due to emails Nephron’s CEO and a sales representative sent concerning its product Budesonide Inhalation Suspension ...
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Lupin gets US FDA approval for dimethyl fumarate delayed release capsules
expresspharma
October 12, 2020
It is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
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US FDA issues warning letter to Shilpa Medicare for Jadcherla facility, Telangana
expresspharma
October 12, 2020
The company believes that the warning letter will have minimum impact of disruption of supplies and the existing revenues from operations of this facility.
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Foresee Pharmaceuticals Announces NDA for CAMCEVI(TM) 42MG Accepted for Review by the FDA
prnasia
October 10, 2020
Foresee Pharmaceuticals Co., Ltd. announced that the 505(b)(2) New Drug Application (NDA) for FP-001 LMIS 50mg, or CAMCEVI™ 42MG, a ready-to-use 6-month depot formulation of leuprolide mesylate, has been accepted for review by the U.S. Food and Drug ...