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31-45 of 3526 results
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
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
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
Japan's MHLW approves Olumiant to treat rheumatoid arthritis
Eli Lilly and Company and Incyte announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted marketing approval for Olumiant (baricitinib) 2-mg and 4-mg tablets for the treatment of rheumatoid arthritis (RA) (including the prevention of structural injury of joints) in patients with inadequate response to standard-of-care therapies.
Regulatory Affairs > News
FDA approves Triptodur to treat central precocious puberty
Arbor Pharmaceuticals and Debiopharm International announced that the US Food and Drug Administration (FDA) has approved Triptodur for the treatment of pediatric patients 2 years and older with central precocious puberty (CPP). CPP occurs when a child shows signs of puberty sooner than normal - before age 8 in girls and 9 nine in boys.
Regulatory Affairs > News
European Commission approves Pfizer's hard-to-treat leukemia drug Besponsa
Pfizer has secured approval from the European Commission for BESPONSA (inotuzumab ozogamicin) as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).
Regulatory Affairs > News
31-45 of 3526 results