Regulatory Affairs

Regulatory Affairs News

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European Commission approves Novartis breast cancer drug Kisqali
Novartis’ breast cancer drug Kisqal has secured authorisation from the European Commission for the treatment of advanced breast cancer.
Regulatory Affairs > News
Epygenix gets FDA orphan drug status for EPX-300 to treat Dravet Syndrome
Epygenix Therapeutics has secured orphan drug status from the US Food and Drug Administration (FDA) for its EPX-300 to treat patients with Dravet Syndrome.
Regulatory Affairs > News
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.
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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