The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...

Unpredictable FDA and funding woes delay crucial drug approvals, depriving thousands of patients access to vital treatments ...

Israeli food tech firm Believer Meats has secured US FDA approval for its cultivated meat, and completed the construction of ...

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.

Mike Pence's think tank is asking the Food and Drug Administration to turn over documents related to the dangers of the ...

The European Union has approved GSK's drug Blenrep to treat relapsed or treatment-resistant forms of a cancer affecting blood ...

Doptelet and new oral sprinkle granules is approved for children one year and older with chronic immune thrombocytopenia, ...

A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

Four months after giving Eli Lilly’s Alzheimer’s disease treatment  a thumbs down, Europe’s Committee for Medicinal Products ...