Regulatory Affairs

Regulatory Affairs News

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EC grants new indication for Soliris to treat refractory generalized myasthenia gravis
Alexion Pharmaceuticals announced that the European Commission (EC) approved the extension of the indication for Soliris (eculizumab) to include the treatment of refractory generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive.
Regulatory Affairs > News
Ironwood’s Duzallo gets FDA approval for gout-associated hyperuricemia
By PBR Staff Writer
Ironwood Pharmaceuticals’ Duzallo has been approved by the US Food and Drug Administration (FDA) for the treatment of hyperuricemia in patients with uncontrolled gout.
Regulatory Affairs > News
AstraZeneca, Merck get FDA approval for expanded use of ovarian cancer drug
By PBR Staff Writer
AstraZeneca and Merck have secured approvals from The US Food and Drug Administration (FDA) to expand the indication for their newly formulated Lynparza to cover a broader group of women suffering from ovarian cancer.
Regulatory Affairs > News
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
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.
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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).
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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.
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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.
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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.
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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.
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Leo Pharma gets EC nod for psoriasis treatment Kyntheum
By PBR Staff Writer
AstraZeneca’s subsidiary MedImmune announced that its partner Leo Pharma has secured approval from the European Commission (EC) for its Kyntheum (brodalumab) to treat moderate-to-severe plaque psoriasis.
Regulatory Affairs > News
FDA approves Gilead’s Vosevi to re-treat HCV infection in adults
By PBR Staff Writer
Gilead Sciences has secured approval from the US Food and Drug Administration (FDA) for its Vosevi to re-treat adults with chronic hepatitis C virus (HCV) infection.
Regulatory Affairs > News
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