Don Tracy, Associate Editor

Decision to discontinue marketing authorizations for Relyvrio/Albrioza comes as a result of topline results from the Phase III PHOENIX trial in patients with amyotrophic lateral sclerosis.

Early results have demonstrated that mRNA-3927 has led to a 70% reduction in the relative risk for metabolic decompensation events in patients with propionic acidemia.

Agreement comes as Teva aims to strengthen its biosimilar portfolio as part of its "Pivot to Growth" strategy.

Fanapt was previously approved by the FDA in 2009 as an antipsychotic treatment for schizophrenia.

Approval comes amid positive results from TRILUMINATE trial, which demonstrated improvement in 90% of participants treated for a leaky tricuspid heart valve.

The concussion test, which shows results after 15 minutes, can help evaluate patients up to 24 hours after injury, company says.

Approval would mark first HER2-targeted therapy for biliary tract cancer in the United States.

Treatment approved in combination with ravulizumab or eculizumab, representing minority demographic still suffering after receiving C5 inhibitor therapy for extravascular haemolysis.

In an interview with Pharm Exec Associate Editor Don Tracy, Fady Boctor, President, Chief Commercial Officer, Petros Pharmaceuticals provides his thoughts on what the future looks like when it comes to over-the-counter (OTC) contraceptives.

Company says it remains committed to advancing research for immune-mediated diseases and intends to share trial data at a later date.

Phase II clinical study showed that children as young as six years of age with hepatitis B virus could benefit from treatment with Vemlidy.

Deal aims to commercialize XTX301 for treating advanced solid tumors by leveraging Xilio’s tumor-activated immuno-oncology therapies.

Approval of Vafsen (vadadustat) based on promising results from the INNO2VATE program and additional safety data from use in Japan in adults with chronic kidney disease.

Evolut FX+ transcatheter aortic valve replacement system design includes a larger coronary access window through a modified frame.

In an interview with Pharm Exec Associate Editor Don Tracy, Fady Boctor, President, Chief Commercial Officer, Petros Pharmaceuticals talks about the recent availability of Opill as an over-the-counter (OTC) contraceptive.

Action marks the first FDA-approved blood screening test for malaria.

Winrevair is the first FDA-approved activin signaling inhibitor therapy for pulmonary arterial hypertension.

Reportedly, the oral weight loss pill VK2735 showed promising signs of effectiveness and a tolerable safety profile.

Deal includes the novel treatment CDR132L, which is currently in Phase II clinical trials for heart failure.

Spinoff seeks to aid pharmaceutical companies in accelerating early clinical development programs.

Action marks the first FDA approval of a long-acting treatment for adult patients with neuromyelitis optica spectrum disorder who are positive for the anti-aquaporin-4 antibody.

Despite not having a positive outcome, safety profiles for Keytruda and Lynparza were consistent with previous findings.

In a unanimous decision, the committee recommended Carvykti based on promising data from the Phase III CARTITUDE-4 study, which showed a positive risk-benefit assessment.

Investigation aimed to discern whether the differences in antibiotic prescribing between direct-to-consumer telemedicine appointments and primary care physician telemedicine appointments were due to the care modality or the context of the care.

Tevimbra (tislelizumab-jsgr) has been approved as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma who have previously undergone systemic chemotherapy excluding PD-L1 inhibitors.

Acquisition is highlighted by eneboparatide, Amolyt’s Phase III peptide for hypoparathyroidism with a novel mechanism of action.

Resubmission plan comes amid feedback and a complete response letter issued by the FDA in 2019 for sotagliflozin in the treatment of glycemic control in type 1 diabetes patients with chronic kidney disease.

Data shows that from 2014-2019, pneumococcal vaccinations in seniors increased by 10%, growing sales for Prevnar 13 due to government recommendation in addition to a high-profile advertising campaign.

Submission is based on positive results from the company’s Phase III QUASAR clinical trial, in which Tremfya (guselkumab) produced positive results treating moderately to severely active ulcerative colitis.

The trial of a pharmaceutical-grade CBD for social anxiety disorder, which was the first of its kind to be approved by the FDA, is expected to receive top line results next month.