Replimune Group Inc. received another complete response letter (CRL) from the U.S. FDA for immunotherapy vusolimogene oderparepvec to treat advanced melanoma, sending shares plunging by more than 19% on the April 10 PDUFA date.

The U.S. FDA has accepted for review Telix Pharmaceuticals Ltd’s resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), its radiolabeled glioma imaging product for characterizing progressive or recurrent glioma in adult and pediatric patients. The FDA assigned a Sept. 11, 2026, PDUFA date.

Oricell Therapeutics Holdings Ltd closed a $110 million pre-IPO round to expand its global footprint and advance its lead candidate, a GPC3-targeted autologous CAR T therapy for liver cancer to registrational trials.

More than four decades on from the approval of the first biologic drug, the industry has reached a tipping point, and biotech drugs now outnumber small molecules in the global R&D pipeline.

C4 Therapeutics Inc.’s degrader-antibody conjugate (DAC) strategy gathered more steam with a new collaboration between the firm and Roche AG that brings $20 million up front with the potential for more than $1 billion in discovery, regulatory and commercial milestone payments.

In a decision that maintains the regulatory status quo, the U.S. FDA denied a petition from Harrison.ai to partially exempt certain diagnostic/detection AI devices from premarket review so long as the manufacturer has 510(k) clearance for a device in a similar category and a robust postmarket plan.

Syneron Bio is emerging as one of the most heavily backed new entrants in the macrocyclic peptide space, raising more than $250 million in venture funding and securing a multibillion-dollar deal with Astrazeneca plc as it builds a platform spanning several of the most competitive frontiers in drug development.

The U.S. confirmed the agreement in principle made last December to exempt U.K. pharmaceuticals from import tariffs, as the U.K government put its commitment to spend more on patented drugs into effect.

Founded amid the booming next-generation antibody-drug conjugate (ADC) space, Sidewinder Therapeutics Inc. has emerged from stealth with an oversubscribed $137 million series B round and plans to advance a lead program into the clinic in 2027.

Amplia Therapeutics Ltd. has halted recruitment in its phase II Amplicity trial in advanced pancreatic cancer due to three dose-limiting toxicities related to the chemotherapy regimen, modified FOLFIRINOX (mFOLFIRINOX), which is being administered in combination with lead compound narmafotinib (AMP-945), a focal adhesion kinase inhibitor.