Regulatory Affairs

Regulatory Affairs News

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Amgen’s Repatha approved by FDA for heart attack and stroke prevention
By PBR Staff Writer
Amgen’s cholesterol drug Repatha (evolocumab) has been approved by the US Food and Drug Administration (FDA) to prevent heart attacks, strokes and coronary revascularizations in adults having cardiovascular disease.
Regulatory Affairs > News
Indivior's Sublocade secures FDA approval to treat opioid use disorder
By PBR Staff Writer
Indivior’s Sublocade (buprenorphine extended- release) injection has been approved by the US Food and Drug Administration (FDA) for the treatment of moderate to severe opioid use disorder (OUD).
Regulatory Affairs > News
AstraZeneca submits sNDA for Tagrisso to treat EGFRm NSCLC
By PBR Staff Writer
AstraZeneca has submitted a supplemental new drug application (sNDA) to Japan’s pharmaceuticals and medical devices agency seeking approval for Tagrisso (osimertinib) as a first line treatment for patients with inoperable or recurrent EGFR mutation-positive (EGFRm) non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
European Commission approves Tremfya to treat moderate to severe plaque psoriasis
Janssen-Cilag International announced that the European Commission (EC) has approved Tremfya (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Regulatory Affairs > News
Midatech secures manufacturing certification from Spanish regulatory authority
Midatech Pharma has received manufacturing certification from Spanish regulatory authority AEMPS.
Regulatory Affairs > News
UK regulator accuses Concordia of overcharging NHS for thyroid drug
By PBR Staff Writer
The UK Competition and Markets Authority (CMA) has accused Canadian pharma company Concordia International of abusing its dominant position by increasing the price of a thyroid drug by about 6,000%.
Regulatory Affairs > News
Novartis gets EC approval for Tasigna to treat Ph+ CML-CP in children
By PBR Staff Writer
Novartis has secured approval from the European Commission (EC) for its Tasigna (nilotinib) to treat pediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
Regulatory Affairs > News
Samsung Bioepis’ trastuzumab biosimilar gets EC approval for breast cancer
By PBR Staff Writer
The European Commission (EC) has approved Samsung Bioepis' Ontruzant, a biosimilar version of Genentech’s Herceptin (trastuzumab), for the treatment of breast cancer in early and metastatic stages and also for metastatic gastric cancer.
Regulatory Affairs > News
Roche’s Hemlibra secures FDA approval for hemophilia A with inhibitors
By PBR Staff Writer
Roche’s Hemlibra (emicizumab-kxwh) has been approved by the US Food and Drug Administration (FDA) for routine prophylaxis to prevent or reduce frequency of bleeding episodes in patients with hemophilia A who have factor VIII inhibitors.
Regulatory Affairs > News
Ultragenyx’s Mepsevii secures FDA approval for Mucopolysaccharidosis VII
By PBR Staff Writer
Ultragenyx Pharmaceutical’s enzyme replacement therapy Mepsevii (vestronidase alfa) has secured approval from the US Food and Drug Administration (FDA) for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome) in both children and adults.
Regulatory Affairs > News
AstraZeneca gets FDA nod for Fasenra to treat severe eosinophilic asthma
By PBR Staff Writer
AstraZeneca, along with its wholly owned subsidiary MedImmune, has secured approval from the US Food and Drug Administration (FDA) for Fasenra (benralizumab) for the treatment of severe eosinophilic asthma.
Regulatory Affairs > News
US FDA approves first drug with digital ingestion tracking system
By PBR Staff Writer
Otsuka Pharmaceutical has secured approval from the US Food and Drug Administration for its Abilify MyCite (aripiprazole tablets with sensor), an antipsychotic drug that has an embedded sensor to digitally track if patients have ingested their medication.
Regulatory Affairs > News
Sprycel approval expanded to include treatment of children with Ph+ CML in chronic phase
The US Food and Drug Administration (FDA) has expanded the indication for Bristol-Myers Squibb’s Sprycel (dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Regulatory Affairs > News
EMA’s CHMP recommends Amgen and Allergan’s ABP 215 to treat certain types of cancer
By PBR Staff Writer
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended to approve ABP 215 for the treatment of certain types of cancer.
Regulatory Affairs > News
Merck gets FDA approval for Prevymis to prevent CMV infection and disease in adult allogeneic stem cell transplant patients
Merck has announced that the US Food and Drug Administration (FDA) has approved Prevymis (letermovir) once-daily tablets for oral use and injection for intravenous infusion.
Regulatory Affairs > News
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