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FDA Approves Saphnelo (anifrolumab) for Moderate to Severe Systemic Lupus Erythematosus drugs
August 03, 2021
AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.
KeifeRx Receives FDA Acceptance of Investigational New Drug for Alzheimer's Disease americanpharmaceuticalreview
August 02, 2021
KeifeRx, LLC announced that the company received an acceptance of its Investigational New Drug (IND) application from the US FDA to launch a Phase 3 trial named NILEAD for Nilotinib BE.
FDA grants EUA for Regeneron’s antibody cocktail to prevent Covid-19 pharmaceutical-technology
August 02, 2021
The US Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for Regeneron Pharmaceuticals’ investigational antibody cocktail, REGEN-COV (casirivimab and imdevimab) to prevent Covid-19.
Alkem Laboratories says US FDA inspection at Taloja facility ends with ‘zero’ observations expresspharma
August 02, 2021
Drug firm Alkem Laboratories yesterday said the US health regulator has conducted an inspection of its Taloja facility in Maharashtra, and it ended with ‘zero’ observations.
Zydus Cadila receives final approval from US FDA for Fulvestrant injection expresspharma
August 02, 2021
The drug will be manufactured at the group’s formulation manufacturing facility at Zydus Biologics, Ahmedabad.
FDA Broadens Existing Emergency Use of Lilly and Incyte's Baricitinib in Patients Hospitalized with COVID-19 Requiring Oxygen drugs
August 02, 2021
Eli Lilly and Company and Incyte announced today FDA has broadened the Emergency Use Authorization for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir.
FDA Approves Expanded Botox (onabotulinumtoxinA) Label to Include Eight New Muscles to Treat Adults with Upper Limb Spasticity drugs
August 02, 2021
Allergan, an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion of Botox® to include eight new muscles for the treatment of upper limb spasticity in adults.
Uptravi (selexipag) Receives FDA Approval for Intravenous Use in Adult Patients with Pulmonary Arterial Hypertension (PAH) drugs
August 02, 2021
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the FDA has approved Uptravi (selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients with WHO
Janssen's UPTRAVI IV FDA-Approved for PAH contractpharma
August 02, 2021
New therapeutic option allows patients to avoid short-term treatment interruptions and stay on UPTRAVI therapy.
FDA approves first interchangeable biosimilar insulin product europeanpharmaceuticalreview
July 30, 2021
The first interchangeable biosimilar insulin product will help increase access and affordability of insulin for diabetics.

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