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Regulatory Affairs

Pfizer gets FDA nod for blood cancer treatment Besponsa By PBR Staff Writer
Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Besponsa (inotuzumab ozogamicin) to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Regulatory Affairs > News
FDA lifts clinical hold on study of Multikine for head and neck cancer By PBR Staff Writer
The US Food and Drug Administration (FDA) has lifted the clinical hold it had imposed on the CEL-SCI and Ergomed co-developed Multikine’s phase 3 head and neck cancer study.
Regulatory Affairs > News PharmaTech liquid drugs recalled in US over bacterial contamination By PBR Staff Writer
The US Food and Drug Administration (FDA) has issued an advisory against consumption of all liquid products manufactured by PharmaTech over concerns of possible contamination with a bacteria called Burkholderia cepacia (B. cepacia).
Regulatory Affairs > News
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PharmaTech liquid drugs recalled in US over bacterial contamination
By PBR Staff Writer
The US Food and Drug Administration (FDA) has issued an advisory against consumption of all liquid products manufactured by PharmaTech over concerns of possible contamination with a bacteria called Burkholderia cepacia (B. cepacia).
Regulatory Affairs > News
Clinigen gets EC nod to update product information for Cardioxane
Clinigen Group has secured approval from the European Commission (EC) to update the current product information for Cardioxane.
Regulatory Affairs > News
AbbVie’s Mavyret secures FDA approval for chronic hepatitis C treatment
The US Food and Drug Administration (FDA) has approved AbbVie's Mavyret (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment has been approved by for treating adult patients with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6).
Regulatory Affairs > News
Bristol-Myers Squibb’s Opdivo gets FDA nod for additional indication in colon cancer
By PBR Staff Writer
Bristol-Myers Squibb’s Opdivo (nivolumab) injection has secured approval from the US Food and Drug Administration to treat a subtype of metastatic colorectal cancer (mCRC).
Regulatory Affairs > News
AbbVie’s Maviret approved in Europe for chronic hepatitis C
By PBR Staff Writer
AbbVie’s maviret (glecaprevir/pibrentasvir) has secured the approval of the European Commission for the treatment of chronic hepatitis C virus (HCV) infection in all major genotypes from GT1 to GT6 in adult patients.
Regulatory Affairs > News
Eagle gets complete response letter from FDA on exertional heat stroke drug RYANODEX
Eagle Pharmaceuticals has received a Complete Response Letter from the US Food and Drug Administration (FDA) for its New Drug Application for RYANODEX (dantrolene sodium) for the treatment of exertional heat stroke (EHS), in conjunction with external cooling methods.
Regulatory Affairs > News
GSK receives FDA approval for self-injectable Benlysta formulation
GSK has secured approval from the US Food and Drug Administration (FDA) for a new subcutaneous formulation of Benlysta (belimumab) for the treatment of adult patients with active, autoantibody-positive Systemic Lupus Erythematosus (SLE), who are receiving standard therapy.
Regulatory Affairs > News
Merck secures tentative FDA approval for Lusduna
The US Food and Drug Administration (FDA) has given a tentative approval for LUSDUNA Nexvue (insulin glargine injection) 100 units/mL, a follow-on biologic basal insulin in a pre-filled dosing device.
Regulatory Affairs > News
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