Pharma News

Nirsevimab is the first investigational immunisation designed to protect all infants across the RSV season with a single dose.

The FDA has extended by 90 days its Prescription Drug User Fee Act (PDUFA) decision dates for Amicus Therapeutics’ AT-GAA dual therapy, which includes a Biologics License Application (BLA) for c...

Stealth Biotherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochond...

Evidence continues to gather that "long COVID," that is, continued negative health impacts months after apparent recovery from severe COVID-19, is an important risk for some patients. ...

Researchers reviewed findings from 158 global studies to determine how COVID-19 affects people living with diabetes.

Participants in a small UK study who received a fourth dose of either the Pfizer-BioNTech COVID-19 vaccine, Comirnaty, or the Moderna COVID-19 vaccine, Spikevax, showed a strong immune response. ...

Scientists found that an experimental drug, sodium selenate, is safe and well tolerated in patients with a type of dementia that often strikes early in adulthood. ...

The FDA has asked Clovis Oncology for more clinical trial data on Rubraca (rucaparib) combined with Bristol Myers Squibb’s Opdivo (nivolumab) as a first-line ovarian cancer maintenance treatment,...

Pfizer made the splash of the young week Tuesday morning, inking an acquisition deal with New Haven, Connecticut-based Biohaven Pharma totaling $11.6 billion.  ...

France’s Agency for the Safety of Health Products (ANSM) is filing criminal charges against the institute led by Didier Raoult, the controversial promoter of hydroxychloroquine as a COVID-19 treatme...

The FDA has lifted a clinical hold on Lexington, Mass.-based LogicBio’s early-stage study in pediatric patients with methylmalonic acidemia (MMA) — a rare inherited disorder in which the body c...

The FDA has pushed back its decision date on Pfizer’s and Myovant Sciences’ supplemental New Drug Application (sNDA) for Myfembree (relugolix, estradiol and norethindrone acetate) from May 6 t...