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61-75 of 3532 results
Pfizer, Eli Lilly get FDA fast track status for chronic pain drug Tanezumab
By PBR Staff Writer
Pfizer and Eli Lilly have secured fast track status from the US Food and Drug Administration (FDA) for tanezumab to treat chronic pain in patients with osteoarthritis (OA) and chronic low back pain (CLBP).
Regulatory Affairs > News
FDA asks Endo to withdraw opioid painkiller over abuse risks
By PBR Staff Writer
The US Food and Drug Administration (FDA) has asked Endo Pharmaceuticals to withdraw its Opana ER (oxymorphone hydrochloride) from the market owing to increased abuse of the reformulated opioid pain medication.
Regulatory Affairs > News
FDA approves two-month dosing option of Alkermes’ Aristada for schizophrenia
By PBR Staff Writer
Alkermes has secured approval from the US Food and Drug Administration (FDA) for a two-month dosing option of Aristada to treat schizophrenia.
Regulatory Affairs > News
ViiV Healthcare seeks EMA, FDA approvals for two-drug regimen to treat HIV-1 infection
By PBR Staff Writer
ViiV Healthcare, a joint venture of GlaxoSmithKline (GSK), Pfizer, and Shionogi, is seeking approval from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for the HIV maintenance regimen with two medicines.
Regulatory Affairs > News
Pfizer’s Meningococcal Group B vaccine, Trumenba, gets approval in Europe
Pfizer has secured approval the European Commission (EC) for TRUMENBA (Meningococcal Group B Vaccine) for preventing invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years of age and older.
Regulatory Affairs > News
FDA panel recommends Pfizer’s epoetin alfa biosimilar to treat anemia
By PBR Staff Writer
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of Pfizer's biosimilar to Amgen’s anemia drug Epogen (epoetin alfa) across all indications.
Regulatory Affairs > News
FDA approves Merck’s Keytruda for cancer patients with certain biomarkers
The US Food and Drug Administration (FDA) has granted accelerated approval to Merck’s Keytruda for patients whose cancers have a specific genetic feature (biomarker).
Regulatory Affairs > News
UK’s CMA accuses Merck of breaching competition law
The UK’s Competition and Markets Authority (CMA) has issued a statement of objections to pharmaceutical firm Merck Sharp & Dohme Limited (MSD).
Regulatory Affairs > News
Genentech’s Actemra approved by FDA for giant cell arteritis treatment
Genentech’s Actemra (tocilizumab) subcutaneous injection has been approved by the US Food and Drug Administration (FDA) for the treatment of giant cell arteritis.
Regulatory Affairs > News
EC launches probe into Aspen's pricing practices for cancer drugs
The European Commission has initiated a formal investigation to see whether Aspen Pharma had excessively priced five life-saving cancer medicines.
Regulatory Affairs > News
FDA turns down generic version of GSK's asthma/COPD inhaler Advair Diskus
By PBR Staff Writer
Vectura and its partner Hikma Pharmaceuticals announced that the US Food and Drug Administration (FDA) turned down VR315, a generic version of GlaxoSmithKline’s asthma/COPD inhaler Advair Diskus.
Regulatory Affairs > News
FDA approves Novartis’ Rydapt for AML and rare blood disorders
By PBR Staff Writer
Novartis’ Rydapt (midostaurin) has secured approval from the US Food and Drug Administration (FDA) in newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of systemic mastocytosis (SM).
Regulatory Affairs > News
Shire wins EC conditional approval for Natpar to treat hypoparathyroidism
By PBR Staff Writer
Shire has secured conditional marketing approval from the European Commission (EC) for its Natpar (rhPTH[1-84]) to treat patients with chronic hypoparathyroidism.
Regulatory Affairs > News
EC approves AstraZeneca’s Tagrisso to treat mutation-positive NSCLC
By PBR Staff Writer
AstraZeneca has secured full marketing authorization from the European Commission (EC) for its Tagrisso (osimertinib) 40mg and 80mg once-daily tablets to treat adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
FDA rejects Vernalis’ NDA for cough cold treatment
By PBR Staff Writer
The US Food and Drug Administration (FDA) has rejected Vernalis’ new drug application for cough cold treatment, CCP-07.
Regulatory Affairs > News
61-75 of 3532 results