Alnylam with an untitled letter over the consumer website for Amvuttra, accusing the biotech | The FDA has hit Alnylam with ...

Since it was established nearly a year ago by the FDA, the Commissioner’s National Priority Voucher (CNPV) program has been ...

In the latest update to COVID and vaccine-related discourse bubbling up at the FDA, agency officials have recently blocked ...

In a bid to better deploy its boots-on-the-ground resources, the FDA is pulling back the curtain on a new pilot program, under which the regulator is leveraging “one-day inspectional assessments” to ...

Cell and gene therapy developers must build continuity of engagement to create trust in the modalities, according to a report ...

Following a series of “most favored nation” (MFN) pricing deals with 17 large pharma companies, the Trump administration ...

In France, Wegovy is prescribed as a second-line treatment for obesity, not for people with a lower body mass index (BMI) or ...

With commitments to invest more than $50 billion in building up its U.S. manufacturing presence, Eli Lilly has earmarked an ...

Fresh off gaining an FDA expansion for Auvelity as a treatment for Alzheimer’s disease agitation (ADA), Axsome Therapeutics ...

In an effort to reallocate resources to its growing oncology focus in the face of shrinking COVID-19 vaccine sales, German ...

Novartis is continuing its multiyear overhaul with new plans to shutter its production facility in Wehr, Germany. | Novartis ...

Pfizer is also demonstrating that its commercial portfolio can flourish beyond the historically mammoth sales of its COVID-19 ...