As vaccine policy uncertainty reaches a new level in the U.S., the Centers for Disease Control and Prevention's (CDC’s) team of vaccine advisors is set to deliberate later this week on childhood im |...

The burgeoning field of transthyretin amyloid cardiomyopathy (ATTR-CM), which spurred excitement over a potential $20 billion market, may have just revealed the first indication of a slowdown. | The...

The Trump administration has lined up another country-specific trade agreement, this time with the U.K., which confers Washington’s biggest break on pharmaceutical import tariffs yet. | The Trump...

A new FDA approval for a first-in-class drug has vaulted Otsuka into im | A new FDA approval for a first-in-class drug has vaulted Otsuka into the IgAN disease space, an increasingly competitive...

As the FDA's Commissioner's National Priority Voucher (CNPV) program has picked up steam, with 15 companies now having secured ultrafast drug reviews, questions and criticisms about the initiative |...

When the FDA reworked the prescribing information for Sarepta Therapeutics' Duchenne muscular dystrophy (DMD) gene therapy Elevidys earlier this month, the company touted a plan to study a regimen |...

Anti-vaccine sentiment is alive and well, especially in the U.S. And it was evident in recent weeks as drugmakers revealed their third-quarter earnings, replete with declining vaccine sales. | The...

Maryland is becoming the home away from home for British drugmaker AstraZeneca. | Maryland is becoming the home away from home for British drugmaker AstraZeneca. On Friday, the biopharma powerhouse...

After months of back-and-and forth with the FDA and a third-party manufacturer, Regeneron has

In its mission to grow the reach of its pyruvate kinase (PK) activator Pyrukynd (mitapivat), Agios Pharmaceuticals has come up short of producing an unequivocal win in the key indication of sickle |...

Despite an ongoing ebb and flow in their representation at the highest levels of leadership, women continue to shatter glass ceilings.Even as the first female vice president in U.S. history left...

Both Eli Lilly and Novo Nordisk are denying a telehealth company’s claim of having struck partnerships with the two companies to provide direct access to their popular obesity meds. | Both Eli Lilly...

Johnson & Johnson and Legend Biotech are said to have withdrawn an abstract originally planned for next month’s Amer | “At this point, the abstract was withdrawn in alignment with the authors, and we...

With sluggish pharmaceutical sales in the third quarter coming in below analysts’ expectations, Bayer is acutely aware of the challenges facing its key unit. | Despite the largely stagnant performa...

In a surprise move, the FDA has named the longtime leader of its oncology department, Richard Pazdur, M.D., as the new director of the Center for Drug Evaluation and Research, which oversees most p |...

As the race to develop oncology bispecifics heats up, Pfizer has offered a first look at its strategy to dethrone Keytruda and establish its

Some three months after merging, Mallinckrodt and Endo have taken the next step toward their joint future by spinning off their sterile injectables and generics businesses. | Some three months after...

In late-stage studies, Merck & Co.’s PCSK9-targeted pill achieved low-density lipoprotein cholesterol (LDL-C) reductions similar to those observed with existing injectables. | Merck & Co.’s PCSK9-t...

Becoming a blockbuster in its third full year on the market put Gilead’s cancer treatment Trodelvy on a course to potentially justify the company’s $21 billion

Akeso has data showing ivonescimab can extend the lives of patients with previously treated EGFR-mutated non-small cell lung cancer (NSCLC), results that can give the red-hot PD-(L)1xVEGF bispecifi |...