FDA panel rejects drug that could combat rare terminal illness 02:40 "Some people might think it's alarming that one in three drugs are having a safety problem after approval.If you believe this ...

Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...

The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.

While the CRL derails a near-term clearance, one analyst described the rejection as more of “a speed bump to approval, rather ...

In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...

The FDA has decided not to approve glofitamab plus gemcitabine and oxaliplatin to treat certain patients with relapsed/refractory DLBCL.

The drugs that gained FDA approval right before the deadline for their review were more likely to have post-market safety issues. On the flip-side, drugs with the quickest approvals (under 200 ...

Issues. May 2025, Medicaid ... Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, approved the drug under the FDA’s accelerated approval pathway for a subset of ...

Companies are also communicating earlier and more frequently with the FDA, which can help to avoid issues in the preliminary stages of drug approval and allow drugs to be approved on the first try.

Some experts say that actually shows our drug approval ... “The fact that a post-market safety event has been detected for 1 in 3 drugs tells me that the FDA is looking for these issues, ...

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

On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics ...