Regulatory Affairs

Regulatory Affairs News

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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
Roche secures FDA approvals for cancer drugs Zelboraf and Alecensa
By PBR Staff Writer
Roche has secured approvals from the US Food and Drug Administration (FDA) for its blood cancer drug Zelboraf (vemurafenib) and lung cancer drug Alecensa (alectinib).
Regulatory Affairs > News
FDA lifts clinical hold on Cellectis phase 1 trials with UCART123 in AML and BPDCN
The US Food and Drug Administration (FDA) has lifted the clinical hold, previously announced on September 4, 2017, on Phase 1 trials of Cellectis’ UCART123 product candidate in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Regulatory Affairs > News
Novartis seeks EMA approval for CTL019 for two indications
By PBR Staff Writer
Novartis is seeking approval from the European Medicines Agency (EMA) for its CTL019 (Kymriah or tisagenlecleucel) to treat two forms of blood cancer.
Regulatory Affairs > News
FDA advisory committees recommend approval of Indivior's RBP-6000 to treat opioid use disorder
Indivior has announced that the Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration (FDA) voted 18 to 1 to recommend approval of RBP-6000 for the treatment of opioid use disorder (OUD).
Regulatory Affairs > News
AstraZeneca’s Calquence secures FDA approval for mantle cell lymphoma
By PBR Staff Writer
AstraZeneca’s Calquence (acalabrutinib) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.
Regulatory Affairs > News
FDA approves new dosing for Xarelto to reduce risk of VTE
Janssen Pharmaceuticals reported that 10mg once-daily dose of Xarelto (rivaroxaban) has been approved by the US Food and Drug Administration (FDA) for reducing the continued risk for recurrent venous thromboembolism (VTE) after at least six months of initial anticoagulation therapy.
Regulatory Affairs > News
Lannett, Celgene sign settlement and license agreement related to Thalomid
Lannett has entered into a settlement and license agreement with Celgene, which resolves patent infringement litigation in the US related to Celgene's Thalomid.
Regulatory Affairs > News
FDA accepts Roche’s sBLA for Avastin to treat women with advanced ovarian cancer
Roche has announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental biologics license application (sBLA) for Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the front-line treatment of women with advanced ovarian cancer.
Regulatory Affairs > News
Teva loses Copaxone patent dispute case to Mylan in UK
By PBR Staff Writer
The UK High Court of Justice has given a decision in favor of Mylan and Synthon over their dispute concerning the patent of Teva Phamaceutical Industries’ multiple sclerosis (MS) treatment Copaxone which was ruled to be invalid due to obviousness.
Regulatory Affairs > News
FDA rejects PTC Therapeutics' application for Duchenne drug
By PBR Staff Writer
PTC Therapeutics has failed to secure the approval from the US Food and Drug Administration (FDA) for its experimental drug Ataluren (Translarna) to treat nonsense mutation Duchenne muscular dystrophy (nmDMD).
Regulatory Affairs > News
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