Pharma News

The FDA has granted Breakthrough Therapy designation to Pfizer’s respiratory syncytial vaccine (RSV) candidate, RSVpreF, for the prevention of RSV-associated lower respiratory tract illness in in...

The FDA has told Karyopharm Therapeutics that before the agency will grant market approval for Xpovio (selinexor) for front-line maintenance of advanced or recurrent endometrial cancer, the company...

Fresh data shows that Pfizer's COVID vaccine is far less powerful at preventing infection among children ages 5 to 11 than teens, a finding that could leave some parents of younger children worried...

New Haven, Conn.-based Biohaven Pharmaceutical has struck a global licensing deal with Bristol Myers Squibb (BMS) to develop and market taldefgrobep alfa, an investigational therapy for treating n...

A new methodology simulates counterfactual, time-varying, and dynamic treatment strategies, allowing doctors to choose the best course of action.

AbbVie has filed for an expanded indication for its blockbuster Imbruvica (ibrutinib) as a treatment for chronic graft vs. host disease (cGVHD) in pediatric and adolescent patients who have undergo...

Few would disagree that too much of a good thing is not such a good thing.

The FDA has granted an orphan drug designation (ODD) to the investigational anti-BCMA CAR T-cell therapy CT103A for use as a potential therapeutic option in patients relapsed/refractory multiple my...

Viatris is leaving the biosimilar field just months after winning the landmark FDA approval for the first interchangeable biosimilar product.

With one heart failure nod already in the books, Eli Lilly and Boehringer Ingelheim’s diabetes blockbuster Jardiance (Empagliflozin) just racked up another key approval—opening the door to a mu...

Health Canada has approved Medicago’s Covifenz COVID-19 two-dose vaccine, the first authorized vaccine that uses plant-based proteins.

Massachusetts-based Toxikon Corp., a Labcorp subsidiary, has received an FDA warning letter for good laboratory practice (GLP) violations, including multiple observations of inaccurately recorded ...