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Regulatory Affairs

Eagle gets complete response letter from FDA on 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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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
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
FDA rejects Amgen’s BLA for osteoporosis treatment Evenity
By PBR Staff Writer
The US Food and Drug Administration (FDA) has rejected Amgen and UCB’s biologics license application (BLA) for Evenity (romosozumab) to treat postmenopausal women with osteoporosis
Regulatory Affairs > News
J&J’s Janssen Biotech gets FDA nod for Tremfya to treat plaque psoriasis
By PBR Staff Writer
Johnson & Johnson (J&J) subsidiary Janssen Biotech has secured approval from the US Food and Drug Administration (FDA) for its Tremfya (guselkumab) to treat adults with moderate to severe plaque psoriasis.
Regulatory Affairs > News
FDA advisory committee recommends Novartis’ CTL019 for r/r B-cell ALL
By PBR Staff Writer
The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended Novartis’ CTL019 (tisagenlecleucel) to treat relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).
Regulatory Affairs > News
FDA accepts BMS’ sNDA to review Sprycel in Philadelphia CP CML
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) submitted by Bristol-Myers Squibb (BMS) for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase (CP) chronic myeloid leukemia (CML).
Regulatory Affairs > News
Vaisala: McKesson Specialty Health Achieves over 100 Audits without a Single Observation
Bullet-proof environmental monitoring technology that answers auditors’ questions.
Regulatory Affairs > Case Studies
Shire submits IND for hemophilia A treatment in US
By PBR Staff Writer
Shire has filed an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for its gene therapy drug, SHP654, to treat hemophilia A.
Regulatory Affairs > News
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