X4 Pharmaceuticals Announces EMA Validation of Marketing Authorization Application (MAA) for Mavorixafor for the Treatment of WHIM Syndrome
Submission supported by positive results from global, Phase 3 4WHIM clinical trial; U.S. regulatory approval in WHIM syndrome ...
Managed Healthcare Executive16h
FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower ...
New weight-loss jabs linked to increased cancer risk
Doctors say new research has found a link between weight-loss drugs and cancer, putting users at 'significantly higher risk' ...
BioSpace23h
Biogen Trims Research Workforce, Higher-Dose SMA Drug Accepted for Regulatory Review
In a good-news-bad-news week for Biogen, the company will cut an undisclosed number of employees, just as a higher dose of ...
Investing on MSN17h
Ionis stock rises on FDA, EMA nod for SMA drug dose increase
Investing.com -- Shares of Ionis Pharmaceuticals (NASDAQ: IONS) climbed 7% today after the company announced that regulatory agencies in the United States and Europe have accepted applications for a ...
Pharmaceutical Technology on MSN21h
Biogen’s higher dose Spinraza under review by US and EU regulators
Biogen’s applications for the higher dose regimen of spinal muscular atrophy (SMA) drug Spinraza are now under review in the US and Europe.
Toleranzia AB: Toleranzia AB provides update on clinical trial application
Toleranzia AB (the "Company" or "Toleranzia") announces that the process for the Company's clinical trial application is proceeding in accordance with the medicinal agencies' usual course. On January ...
Warning! Weight loss jabs like Ozempic linked to deadly cancer diagnosis in the year after using them
American doctors have now discovered the injections put users at 'significantly higher' risk compared to three other common diabetes drugs.
Pharmabiz9h
Jaguar Health begins patient dosing in investigator-initiated POC trial of crofelemer for rare disease indication of MVID
San Francisco, California Friday, January 24, 2025, 11:00 Hrs [IST] ...
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Intellia doses first subject in trial of NTLA-2002 for hereditary angioedema
The HAELO trial will assess the therapy’s safety and efficacy in 60 adult subjects with Type I or Type II HAE.
Moderna Awarded Tender for the Supply of Its mRNA COVID-19 Vaccine in the European Union
The Agreement provides participating countries with the opportunity to diversify their mRNA COVID-19 vaccine supply and gain access to pre-filled ...