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

The U.S. Food and Drug Administration has extended its review of Bayer's experimental menopause relief drug, the German ...

Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.

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 ...

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

The US Food and Drug Administration (FDA) has approved an improved stool collection kit of Geneoscopy’s RNA-based colorectal ...

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

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

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

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

GoodRx reports that insurance coverage for GLP-1 medications varies. It's more likely when prescribed for FDA-approved uses ...