Merck & Co., Inc. MRK gained FDA approval for its supplemental new drug applications (sNDAs) looking for label expansion of its two new HIV drugs — Pifeltro and Delstrigo.

After marquee HIV drug approvals last year for Gilead and GlaxoSmithKline, Merck will follow into the crowded market with two new meds. The drugmaker scored FDA approvals for a new non-nucleoside ...

Merck MRK announced that the FDA has accepted for review the new drug application (“NDA”) seeking approval for its ...

The new drug application is supported by 48-week data from the Phase III MK-8591A-051 and MK-8591A-052 trials, which showed ...

Keytruda is Merck's best-selling drug, generating more than $7 billion in revenue in the first quarter. Merck ( MRK ) has received the go-ahead to expand use of its blockbuster cancer drug, Keytruda.

Aug 30 (Reuters) - Drugmaker Merck & Co Inc said on Thursday the U.S. Food And Drug Administration approved two of its oral medicines to treat HIV patients. U.S. regulators approved Delstrigo, a ...

Why FDA approval of new HIV prevention drug is a big deal 02:25. The U.S. Food and Drug Administration has approved the drug lenacapavir as a twice-yearly injection to prevent HIV.

The drug, Apretude, is approved for at-risk adults and adolescents who weigh at least 77 pounds to reduce the risk of sexually acquired HIV, the FDA announced Monday.