#drug approval

All articles tagged with "drug approval"

FDA clears Gilead’s hepatitis D treatment after a four-year delay tied to manufacturing issues

The FDA has approved Gilead’s hepatitis D drug Hepcludex, ending a four-year wait after the therapy was previously rejected over manufacturing and distribution problems.

Key Takeaways

The FDA approved Gilead’s hepatitis D drug Hepcludex.
The therapy had been rejected four years earlier over manufacturing and distribution issues.

DT Editorial Team·May 23, 2026·via endpoints.news

FDA clears Merck’s once-daily two-drug HIV tablet for adults with suppressed virus

The FDA has approved Merck’s Idvynso, a once-daily two-drug tablet for certain adults with HIV-1, adding a new oral option for people who are already virologically suppressed.

Key Takeaways

The FDA approved Idvynso for adults with HIV-1 who are already virologically suppressed.
The once-daily tablet combines doravirine and islatravir in a single pill.

DT Editorial Team·May 2, 2026·via medicalxpress.com

Replimune’s second FDA rejection keeps pressure on biotech regulation and cancer drug risk

Replimune’s skin cancer therapy has reportedly been rejected by the FDA again, extending a high-profile regulatory setback that had already become a flashpoint in agency debates.

Key Takeaways

Replimune’s skin cancer drug was reportedly rejected by the FDA for a second time.
The case had already become a flashpoint in FDA debates.

DT Editorial Team·Apr 11, 2026·via statnews.com

FDA Clears a New Weight-Loss Pill at Unusual Speed

A newly approved daily weight-loss pill moved through U.S. FDA review faster than most drugs in recent years, signaling continued momentum in the obesity treatment market.

Key Takeaways

The FDA has approved a new daily weight-loss pill.
The review moved faster than most recent drug approvals.

DT Editorial Team·Apr 3, 2026·via medicalxpress.com

Health

The FDA has approved Johnson and Johnson's icotrokinra, branded Icotyde, for moderate-to-severe psoriasis in patients aged 12 and up — a drug the company expects to become a multi-billion dollar blockbuster.

DT Editorial Team·Mar 19, 2026·3 min read·via endpoints.news

#drug approval

FDA clears Gilead’s hepatitis D treatment after a four-year delay tied to manufacturing issues

FDA clears Merck’s once-daily two-drug HIV tablet for adults with suppressed virus

Replimune’s second FDA rejection keeps pressure on biotech regulation and cancer drug risk

FDA Clears a New Weight-Loss Pill at Unusual Speed

FDA clears Gilead’s hepatitis D treatment after a four-year delay tied to manufacturing issues

FDA clears Merck’s once-daily two-drug HIV tablet for adults with suppressed virus

Replimune’s second FDA rejection keeps pressure on biotech regulation and cancer drug risk

FDA Clears a New Weight-Loss Pill at Unusual Speed

FDA Approves J&J's Icotyde, a New Psoriasis Pill With $5B+ Potential