Replimune’s application is the latest example of changing attitudes at the FDA. Elsewhere, Revolution Medicines outlined more RAS-blocking data and a Definium stock offering brought in $800 million.
An article from
News roundup
Replimune’s application is the latest example of changing attitudes at the FDA. Elsewhere, Revolution Medicine outlined more RAS-blocking data and a Definium stock offering brought in $800 million.
Published June 26, 2026
By
FDA advisory panels are back, with new meetings for Replimune, Capricor
FDA reverses course on Regenxbio’s childhood gene therapy after rejection
Merck KGaA throws down $11.3B for Bio-Techne in its biggest deal since 2015 Sigma-Aldrich buy
Another big deal, another sign biotech M&A is back
Regenxbio to resubmit Hunter syndrome gene therapy as FDA rare disease about-face continues
Europe's CHMP reverses endorsement of Amgen's Tavneos as FDA hearing looms
Boundless Bio's reverse merger; CARsgen wins first solid tumor approval for CAR-T
Replimune was among the drugmakers that had criticized the FDA for what they called inconsistent guidance around trials and…
Replimune will resubmit advanced melanoma drug RP1 to the FDA after two rejections, following the ouster of Commissioner Marty…
A twice-spurned therapy that’s been seen as one of the FDA’s more controversial recent rejections is getting a new chance…
Pharma updates from the Pharmalot campus via the Pharmalittle newsletter
Replimune Group (REPL) shares gain on key RP2 & RP1 oncology data presentations at ASCO. Read the clinical trial results.
US stocks up, Dow Jones up 171 pts. Replimune Group rises after FDA agreement. Other big gainers include Dell, NetApp, and Okta.
