Regulatory & Policy
Partner Therapeutics seeking third indication for Bizengri in NRG1 fusion-positive cholangiocarcinoma
Partner Therapeutics submitted a supplemental Biologics License Application (sBLA) to the US FDA on April 14, 2026 for Bizengri (zenocutuzumab-zbco),...
Dogwood/Serpin's LRP1 agonist gets FDA IND nod for chemotherapy-induced neuropathy
Dogwood Therapeutics (Nasdaq: DWTX) announced on April 15, 2026 that the US FDA has accepted an investigational new drug application for SP16, an...
RemeGen adds 5th China indication for HER2 ADC, in urothelial carcinoma
IMPORTANT NOTICE: The source data describes a regulatory approval by China's NMPA — not a regulatory submission or filing. The article below accurately...
FDA accepts Telix's Pixclara resubmission for recurrent or progressive glioma imaging
Telix Pharmaceuticals has submitted a resubmitted New Drug Application (NDA) to the US FDA for Pixclara (floretyrosine F 18), a positron emission tomography...
DualityBio files HER2 ADC trastuzumab pamirtecan for 1st approval in China
DualityBio submits a Biologics License Application (BLA) to China's National Medical Products Administration (NMPA) for trastuzumab pamirtecan (T-Pam;...
Nuvalent's files with FDA for neladalkib in TKI pre-treated ALK-positive lung cancer
Nuvalent submitted a New Drug Application to the US FDA on April 7, 2026, for neladalkib, an investigational ALK-selective tyrosine kinase inhibitor,...
Neurocrine target Soleno withdraws EU market approval filing for Viokat
Note to editor: The source material concerns a regulatory withdrawal, not a submission or approval filing. The article has been written to accurately...
MHRA accepts Savara's Molbreevi application for autoimmune pulmonary alveolar proteinosis treatment
Savara Inc. has submitted a Marketing Authorisation Application (MAA) to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for MOLBREEVI...
Quantum Bio filed IND for Lucid-MS to start Phase II in multiple sclerosis
Quantum BioPharma submitted an IND application to the U.S. Food and Drug Administration in March 2026 for Lucid-21-302, known as Lucid-MS, a small-molecule...
FDA accepts Ultragenyx's UX111 gene therapy resubmission for Sanfilippo syndrome Type A treatment
Ultragenyx Pharmaceutical has submitted a resubmitted Biologics License Application to the US FDA for UX111 (rebisufligene etisparvovec), an AAV9 gene...
Cogent files KIT-targeted bezuclastinib plus sunitinib for approval in imatinib-pretreated GIST
Cogent Biosciences has submitted a New Drug Application to the US FDA for bezuclastinib, a selective KIT tyrosine kinase inhibitor, seeking approval for use...
FDA extends review of Orca Bio's Orca-T for hematologic malignancies to July 2026
Orca Bio has announced that the US FDA extended the review timeline for its Biologics License Application (BLA) for Orca-T, an investigational allogeneic...
BridgeBio files NDA for BBP-418 in limb-girdle muscular dystrophy type 2I/R9
BridgeBio Pharma submitted a New Drug Application to the US FDA on 30 March 2026 for oral BBP-418, seeking approval for the treatment of individuals living...
Pfizer partner RemeGen takes 4th China indication for HER2-ADC disitamab vedotin, in HER2-low breast cancer
IMPORTANT NOTICE: The source material describes a regulatory approval by China's NMPA — not a submission or filing. The article brief requests coverage of a...
FDA approves Biogen's high dose Spinraza regimen for spinal muscular atrophy
The US FDA has approved a high dose regimen of Spinraza (nusinersen) for the treatment of spinal muscular atrophy, the agency and developer Biogen announced...
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