Regulatory & Policy
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...
Acurx Pharmaceuticals Secures US Patent for Innovative DNA Polymerase IIIC Inhibitor Technology
USPTO Grants Acurx Pharmaceuticals Patent for Innovative DNA Polymerase IIIC Inhibitor Technology
FDA Issues Complete Response Letter to Disc Medicine for Bitopertin in Erythropoietic Protoporphyria Treatment
Disc Medicine, Inc. (NASDAQ: IRON) disclosed on February 13, 2026, that the U.S. Food and Drug Administration issued a Complete Response Letter for the New...
FDA Approves GSK's Arexvy for At-Risk Adults Aged 18–49 Against RSV Disease
The US FDA has approved an expanded age indication for Arexvy (respiratory syncytial virus vaccine, adjuvanted), GSK's recombinant protein-based RSV...
MeiraGTx's AAV2-hAQP1 gene therapy earns FDA breakthrough designation for radiation-induced xerostomia
MeiraGTx Holdings plc (Nasdaq: MGTX), a clinical-stage genetic medicines company headquartered in London and New York, announced that the FDA has granted...
FDA approves Corcept Therapeutics' Lifyorli for platinum-resistant ovarian cancer
The US FDA on March 25, 2026, approved Lifyorli (relacorilant) in combination with nab-paclitaxel for the treatment of adults with platinum-resistant...
China's NMPA approves Xdemvy for Demodex blepharitis, triggering $15M milestone payment to Tarsus
China's National Medical Products Administration has approved XDEMVY (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis, making...
Remix Therapeutics' REM-422 Earns FDA Fast Track Designation for Adenoid Cystic Carcinoma Treatment
Remix Therapeutics, a clinical-stage biotechnology company headquartered in Watertown, Massachusetts, announced that the US FDA has granted Fast Track...
Aldeyra Therapeutics receives CRL for reproxalap citing lack of efficacy in dry eye disease
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) disclosed that the U.S. Food and Drug Administration issued a Complete Response Letter for the New Drug...
ARTHEx Biotech Secures FDA Fast Track Designation for ATX-01 in Myotonic Dystrophy Type 1
ARTHEx Biotech, a clinical-stage biotechnology company headquartered in Valencia, Spain, announced that the U.S. Food and Drug Administration (FDA) has...
FDA accepts Cogent Biosciences' NDA for bezuclastinib in non-advanced systemic mastocytosis
Cogent Biosciences announced that the US FDA has accepted its New Drug Application for bezuclastinib in patients with non-advanced systemic mastocytosis...
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