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Regulatory Affairs

Adapt Pharma submits NDA to FDA for Narcan nasal spray Adapt Pharma Limited has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Narcan (naloxone) Nasal Spray, an investigational drug intended to treat opioid overdose.
Regulatory Affairs > News
FDA approves Amgen's Kyprolis for combination use to treat relapsed multiple myeloma Amgen has announced that the US Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Kyprolis (carfilzomib) for Injection in combination with Revlimid (lenalidomide) and dexamethasone (KRd) for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy.
Regulatory Affairs > News Shire gets EMA Committee positive opinion for Intuniv to treat ADHD Shire announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of the once-daily, non-stimulant Intuniv (guanfacine hydrochloride extended release; GXR) for the treatment of attention deficit/hyperactivity disorder (ADHD) in children and adolescents.
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Novartis' Odomzo skin cancer drug gets FDA approval
By PBR Staff Writer
Swiss pharmaceutical firm Novartis has received approval from the US Food and Drug Administration (FDA) for Odomzo (sonidegib, formerly LDE225) 200mg capsules to treat adult patients with locally advanced basal cell carcinoma (laBCC).
Regulatory Affairs > News
Health Canada approves Theravance's Vibativ for HAP/VAP caused by gram-positive bacteria
By PBR Staff Writer
Theravance Biopharma has received approval from Health Canada for Vibativ (telavancin) to treat adults with hospital-acquired bacterial pneumonia (HAP) and ventilator-associated bacterial pneumonia (VAP).
Regulatory Affairs > News
Merck’s Keytruda gets European Commission approval to treat advanced melanoma
By PBR Staff Writer
The European Commission (EC) has approved Merck's anti-PD-1 therapy, Keytruda (pembrolizumab), to treat advanced (unresectable or metastatic) melanoma in adults.
Regulatory Affairs > News
Genmab's partner Novartis submits sBLA to FDA for ofatumumab to treat relapsed CLL
By PBR Staff Writer
Danish biotechnology firm Genmab has announced the submission of a supplemental Biologics License Application (sBLA) to the US FDA to use its human monoclonal antibody ofatumumab (Arzerra) as maintenance therapy of patients with relapsed chronic lymphocytic leukemia (CLL).
Regulatory Affairs > News
European Commission approves Amgen's Repatha to treat high cholesterol
Amgen announced that the European Commission (EC) has granted marketing authorization for Repatha (evolocumab), the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in the world, for the treatment of patients with uncontrolled cholesterol who require additional intensive low-density lipoprotein cholesterol (LDL-C) reduction.
Regulatory Affairs > News
Bristol-Myers gets FDA breakthrough therapy status for investigational HIV-1 attachment inhibitor
By PBR Staff Writer
Bristol-Myers Squibb has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational compound BMS-663068 when used in combination with other antiretroviral (ARV) agents to treat HIV-1 infection in heavily treatment-experienced adult patients.
Regulatory Affairs > News
Merck gets approval in Europe to extend Kuvan use for children with PKU
By PBR Staff Writer
The European Commission (EC) has authorized a change to the marketing authorization for Merck's product Kuvan (sapropterin dihydrochloride), to allow its use in children with phenylketonuria (PKU) below four years of age who have been shown to be responsive to such treatment.
Regulatory Affairs > News
Motif’s Iclaprim gets FDA QIDP designation for HABP
By PBR Staff Writer
The US Food and Drug Administration (FDA) has designated UK-based biopharmaceutical firm Motif Bio's iclaprim, a broad-spectrum antibiotic, as a Qualified Infectious Diseases Product (QIDP) to treat hospital acquired bacterial pneumonia (HABP).
Regulatory Affairs > News
Scioderm to submit rolling NDA to FDA for Zorblisa
Scioderm, a clinical-stage biopharmaceutical company focused on developing innovative therapies for treating diseases with high unmet need, including rare diseases, announced that it has agreed with the US Food and Drug Administration (FDA) to submit a rolling New Drug Application (NDA) submission for Zorblisa (SD-101), a proprietary and novel topical therapy for the treatment of blisters and lesions in patients with Epidermolysis Bullosa (EB), a rare genetic connective tissue disorder.
Regulatory Affairs > News
Viking Therapeutics submits IND application for VK5211 in acute hip fracture
Viking Therapeutics, a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders, announced that it has submitted an investigational new drug (IND) application to the Food and Drug Administration (FDA) to initiate clinical development of VK5211 in patients with acute hip fracture.
Regulatory Affairs > News
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