The FDA needs more time to review Novo’s investigational bispecific antibody for hemophilia A before making an approval decision, citing manufacturing issues as the reason behind the delay. The agency ...
The U.S. Food and Drug Administration has extended its review of Novo Nordisk A/S’ NVO Biologics License Application for ...
Viatris said it will acquire Pacira Biosciences for $1.65 billion. GE HealthCare will acquire Sofie Biosciences for $945 ...
On October 5, 2026, Shionogi & Co., Ltd. entered into an agreement to acquire all shares of IntraBio Inc., a US biopharmaceutical company specializing in the rare neurological disease field, for 2 ...
The FDA has approved pritelivir (Hovilpri) tablets for adults with weakened immune systems who have mucocutaneous lesions ...
Teva has received FDA approval for once monthly injectable schizophrenia drug Weltruza. The announcement sent Teva shares ...
The FDA has approved pritelivir to treat mucocutaneous lesions caused by herpes simplex virus in immunocompromised adult ...
Pritelivir (Hovilpri) healed all lesions by day 28 in 63% of immunocompromised adults with refractory HSV versus 34% with investigator's choice in the phase 3 PRIOH-1 trial. The FDA has approved ...
A new class of medicines offers steadier protection with fewer injections, while gene therapy is beginning to test the promise of a one-time treatment.
A federal judge in Louisiana ordered the FDA to provide an update on its safety study as part of a lawsuit seeking to ...
The Food and Drug Administration says its ongoing safety review of the nation’s main abortion pill will continue into next ...
Accepted for Priority Review with a PDUFA target action date of February 4, 2027; being granted Priority Review by the FDA underscores the significant unmet need for an oral targeted therapeutic ...
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