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

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

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

New Jersey-based drugmaker Bristol Myers Squibb this month dedicated its first production facility in Indiana, a former north ...

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

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

Institutional investors including Armistice Capital, RTW Investments, and Wellington Management have increased their exposure ...

The approval was based on data from the randomized, double-blind, placebo-controlled phase 3b AVA-PED-301 trial.

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

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

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

As life-extending technologies and aging interventions proliferate, questions surround who will be granted access to a longer ...