Regulatory & Policy
China Medical System submits NDA in China for IL-4Ralpha mAb comekibart in seasonal allergic rhinitis
China Medical System submits NDA for long-acting IL-4Rα antibody in seasonal allergic rhinitis
Belite Bio initiates NDA submission for tinlarebant in Stargardt disease type 1
Belite Bio has initiated a rolling New Drug Application (NDA) submission to the US FDA for tinlarebant (LBS-008), an oral investigational therapy targeting...
FDA accepts Dogwood Therapeutics' SP16 IND application for chemotherapy-induced pain and neuropathy
Dogwood Therapeutics announced that the US FDA has accepted an Investigational New Drug (IND) application for SP16, an intravenously administered...
Renaissance Pharma's daretabart receives FDA Fast Track designation for high-risk neuroblastoma
Renaissance Pharma Limited announced in April 2026 that the US FDA had granted Fast Track Designation for daretabart (hu1418K322A) and cleared the company's...
FDA delays review of Savara's molgramostim inhalation solution for autoimmune PAP to November
The US FDA has extended its review period for the Biologics License Application (BLA) submitted by Savara Inc. for molgramostim inhalation solution...
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...
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