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TAGRISSO granted FDA breakthrough therapy status in EGFR-mutated lung cancer
pharmaceutical-business-review
August 05, 2020
AstraZeneca’s TAGRISSO (osimertinib) has been granted Breakthrough Therapy Designation (BTD) in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer...
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Truvian Receives FDA Emergency Use Authorization for COVID-19 IgM/IgG Test
americanpharmaceuticalreview
August 05, 2020
Truvian Sciences announced the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company's Easy Check COVID-19 IgM/IgGTM antibody test.
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INOVIO Receives Orphan Drug Designation for Recurrent Respiratory papillomatosis Treatment
americanpharmaceuticalreview
August 05, 2020
INOVIO announced the U.S. Food and Drug Administration (FDA) granted orphan drug designation for INO-3107, its DNA medicine being evaluated in a Phase 1/2 trial for treatment of recurrent respiratory papillomatosis (RRP).
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US FDA approves SPRAVATO, antidepressant medication from J&J
expresspharma
August 05, 2020
The drug indicated to treat adults with major depressive disorder and acute suicidal ideation or behaviour reportedly begins improving depressive symptoms with the first dose.
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Maha FDA seizes 15 vials of tocilizumab black marketed at Rs one lakh each
expresspharma
August 05, 2020
The Maharashtra Food and Drug Administration (FDA) has seized 15 vials of tocilizumab from a non-authorised license holder in Bandra, Mumbai. The team has arrested and filed an FIR against him.
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FDA approves Epidyolex for treatment of tuberous sclerosis complex-associated seizures
europeanpharmaceuticalreview
August 04, 2020
Epidyolex, a cannabidiol oral solution, has been given approval by the FDA to treat seizures associated with tuberous sclerosis complex (TSC).
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FDA proposes four APIs for bulk substances list for outsourcing facilities
europeanpharmaceuticalreview
August 03, 2020
Four APIs are being considered by the FDA for its bulk drug substances list for potential use by outsourcing facilities when compounding if there is a clinical need.
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FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory Mantle Cell Lymphoma
americanpharmaceuticalreview
August 03, 2020
The U.S. Food and Drug Administration (FDA) granted accelerated approval to brexucabtagene autoleucel (TECARTUS, Kite, a Gilead Company).
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US FDA grants Breakthrough Therapy Designation for Takeda’s Pevonedistat
expresspharma
August 03, 2020
The investigational drug is for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS).
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Zydus Cadila gets tentative US FDA approval for Carbidopa and Levodopa extended-release capsules
expresspharma
August 03, 2020
This medication is used to treat the symptoms of Parkinson’s disease or Parkinson-like conditions.