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US breakthrough designation for ligelizumab in chronic spontaneous urticaria
pharmatimes
January 18, 2021
The US Food and Drug Administration (FDA) has granted Novartis’ ligelizumab a breakthrough therapy designation for the treatment of patients with chronic spontaneous urticaria (CSU) who have an inadequate response to H1-antihistamine treatment.
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FDA’s Office of Generic Drugs Receives Approval to Undergo Reorganization
americanpharmaceuticalreview
January 15, 2021
The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced the approval of the Office of Generic Drugs’ (OGD) reorganization.
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FDA Approves ORGOVYX for Advanced Prostate Cancer
americanpharmaceuticalreview
January 15, 2021
The U.S. Food and Drug Administration (FDA) approved ORGOVYX (relugolix) for the treatment of adult patients with advanced prostate cancer.
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Abbott Receives FDA 510(k) Clearance for Rapid Handheld Blood Test for Concussions
americanpharmaceuticalreview
January 15, 2021
Abbott has received 510(k) clearance for the first rapid handheld traumatic brain injury (TBI) blood test, which will help clinicians assess individuals with suspected mild TBIs, including concussions.
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Amydis Announces Successful Completion of Pre-IND Meeting with the FDA
americanpharmaceuticalreview
January 15, 2021
Amydis announced successful completion of pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plan for its lead candidate, AMDX-2011P, a small-molecule retinal tracer that targets ...
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Strides gets USFDA approval for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets
expresspharma
January 15, 2021
The combination of Emtricitabine and Tenofovir slows down the spread of HIV in the body and is used along with other medications to treat HIV in adults and children.
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Pfizer gets USFDA nod for XALKORI (crizotinib) to treat ALK-positive ALCL in children and young adults
expresspharma
January 15, 2021
XALKORI is the first biomarker-driven therapy for relapsed or refractory ALCL in young people.
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RedHill Biopharma's RHB-204 Granted FDA Fast Track Designation for NTM Disease
americanpharmaceuticalreview
January 14, 2021
RedHill Biopharma announced that RHB-204 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its development as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) ...
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Radius Health Announces Acquisition of Orphan Disease Program
americanpharmaceuticalreview
January 14, 2021
Radius Health announced a definitive agreement to acquire the global development and commercialization rights to Benuvia Therapeutics (Benuvia) synthetic cannabidiol oral solution (RAD011).
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FDA accepts priority review of Merck’s pneumococcal vaccine
pharmaceutical-technology
January 14, 2021
The US Food and Drug Administration (FDA) has accepted priority review of the Biologics License Application (BLA) of Merck’s investigational 15-valent pneumococcal conjugate vaccine candidate, V114, for preventing invasive pneumococcal disease in adults.