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.
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. At the start of the biotech industry, progress was slow. Between 1983 and 1995, the U.S. FDA approved an average of two biologics each year. Now, biologics have taken the lead by the smallest of margins, accounting for 50.1% of drugs in development at the start of 2026, according to the Pharma Annual Review 2026, published by Pharmaprojects, a firm that tracks global pharma R&D.
Nyrada Pty Ltd. has synthesized new short transient receptor potential channel 6 (TRPC6) and 7 (TRPC7) antagonists potentially useful for the treatment of cancer.
Aurigene Oncology Ltd. and Olema Pharmaceuticals Inc. have disclosed new proteolysis targeting chimera (PROTAC) compounds comprising an E3 ubiquitin ligase CBL-B (CBLB)-binding moiety coupled to a histone acetyltransferase KAT6A (MOZ; MYST-3)-targeting moiety. They are described as potentially useful for the treatment of cancer.
Avelos Therapeutics Inc. has divulged new sulfur or selenium-containing compounds acting as DNA polymerase θ (POLθ; POLQ) inhibitors potentially useful for the treatment of cancer.
A Purdue Research Foundation patent details the discovery of 5/5-5/6 bisaryl compounds acting as mitogen-activated protein kinase kinase kinase 7 (MAP3K7; TAK1) inhibitors reported to be useful for the treatment of multiple myeloma and inflammatory disorders.
Beone Medicines I GmbH and Beone Pharmaceutical (Suzhou) Co. Ltd. have identified new macrocyclic GTPase KRAS inhibitors potentially useful for the treatment of cancer.
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