Pharma News, 2023

Fezolinetant, Astellas Pharma’s potential first-in-class treatment for menopausal hot flashes, shouldn’t cost more than $2,600 per year if approved, according to a cost-benefit analysis by the Ins...

The FDA has updated its emergency authorizations for Pfizer’s Paxlovid (nirmatrelvir, ritonavir) and Merck’s Lagevrio (molnupiravir) to allow dispensing of the drugs without a positive COVID-19...

GSK plc  today announced that the US Food and Drug Administration (FDA) has approved Jesduvroq (daprodustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the o...

The FDA has extended its decision date on argenx’s biologics license application (BLA) for subcutaneous efgartigimod for the treatment of adults with generalized myasthenia gravis to June 20. ...

A federal court in Florida has issued a consent decree against LGM Pharma, a Boca Raton-based active pharmaceutical ingredient (API) importer and distributor, prohibiting the company from distribut...

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Jazz Pharmaceuticals’ Epidyolex (cannabidiol,100 mg/ml oral solution) for National Health Service (NHS) use as ...

The FDA has approved an expanded label for sutimlimab-jome (Enjaymo, Sanofi) with new long-term safety and efficacy data for individuals with cold agglutinin disease (CAD), to now include patients...

The European Commission (EC) has expanded its marketing authorization for Sanofi and Regeneron’s blockbuster drug Dupixent (dupilumab) to treat adults and adolescents 12 years and older with eos...

Roche and Boehringer Ingelheim have both formed partnerships with tech companies this week to develop and deploy wearable biosensor technology for use in clinical trials and patient monitoring. ...

Eli Lilly’s Jaypirca (pirtobrutinib) has gained FDA accelerated approval for treatment of adult patients with relapsed or resistant mantle cell lymphoma after at least two lines of systemic thera...

The FDA has approved Stemline Therapeutics’ Orserdu (elacestrant) as the first treatment for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastati...

Cassava Sciences is claiming a phase 2 win with its investigational Alzheimer’s treatment simufilam in patients with mild-moderate disease — but the open-label study lacks a placebo comparator,...