In March, the FDA approved Janssen Pharmaceuticals’ depression drug esketamine, a form of...
- FDA greenlight for esketamine sheds light on ketamine’s potential
- BMS’ Opdivo plus Yervoy for RCC to be available through NHS Scotland
- Everest Medicines to commercialise Calliditas’ Nefecon in Greater China and Singapore
- FDA approves first drug for episodic cluster headaches
- Berkeley scientists discover Chinese CRISPR babies at higher risk of early death
FDA greenlight for esketamine sheds light on ketamine’s potential
In March, the FDA approved Janssen Pharmaceuticals’ depression drug esketamine, a form of ketamine for use as a treatment for depression. Billed as the most exciting antidepressant in decades, the drug has an entirely new mechanism of action. So what does esketamine offer, and why is the FDA so sure the benefits outweigh the risks?
Merck’s Keytruda secures expanded indications in US
The US Food and Drug Administration (FDA) has approved two indications for Merck’s Keytruda, expanding its application to the oncology market.
BMS’ Opdivo plus Yervoy for RCC to be available through NHS Scotland
Scotland’s healthcare pricing regulator the Scottish Medicines Consortium (SMC) has decided to fund Bristol Myers-Squibb (BMS)’s Opdivo (nivolumab) plus Yervoy (ipilimumab) for use in NHS Scotland for renal cell carcinoma (RCC) patients, who are previously untreated and considered to be of intermediate or poor prognostic risk.
Regulators demand more details on Roche’s $4.8bn Spark acquisition
The US Federal Trade Commission (FTC) has requested that both Roche and Spark Therapeutics submit additional information and documentary material regarding their proposed merger agreement.
Genentech receives FDA approval for Polivy to treat DLBCL
Genentech has received accelerated approval from the US Food and Drug Administration (FDA) for the use of Polivy (polatuzumab vedotin-piiq) in combination with bendamustine and rituximab (BR) to treat diffuse large B-cell lymphoma (DLBCL) in adults.
Everest Medicines to commercialise Calliditas’ Nefecon in Greater China and Singapore
Sweden-based Calliditas Therapeutics has announced that Everest Medicines will commercialise its IgA nephropathy (IgAN) drug Nefecon in Greater China, which encompasses China, Hong Kong, Macau and Taiwan, and Singapore.
FDA advisory panel recommends TB Alliance’s tuberculosis drug
An advisory panel to the US Food and Drug Administration (FDA) has recommended the approval of TB Alliance’s investigational drug pretomanid in combination with bedaquiline and linezolid to treat drug-resistant tuberculosis.
FDA grants fast-track designation to bone marrow cancer drug
Sierra Oncology has received the US Food and Drug Administration's (FDA) fast track designation for its investigational drug momelotinib.
Landmark study shows pharma worse than the automotive industry for carbon emissions
In addition to the lack of awareness of pharma’s contribution to climate change, lack of adequate regulation is a key contributing factor.
FDA agrees to review Celgene-Acceleron’s luspatercept in anaemia
The US Food and Drug Administration (FDA) has accepted a biologics licence application (BLA) for Celgene and Acceleron Pharma’s luspatercept.
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