Regulatory & Policy
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 approves Rocket Pharmaceuticals' gene therapy Kresladi for severe pediatric leukocyte adhesion deficiency-I
The US FDA has granted accelerated approval to KRESLADI (marnetegragene autotemcel), an autologous hematopoietic stem cell-based gene therapy developed by...
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...
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...
Aprea Therapeutics secures Australian and Japanese patents for WEE1 and ATR inhibitor cancer programs
Aprea Therapeutics, Inc. (Nasdaq: APRE), a clinical-stage biopharmaceutical company headquartered in the US, announced the expansion of its global...
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...
Diamyd Medical Secures Crucial US Patent for Intralymphatic Type 1 Diabetes Immunotherapy Approach
Diamyd Medical Secures Key US Patent Protection for Intralymphatic Type 1 Diabetes Immunotherapy Approach
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...
AnaCardio and Helsinn secure US patent for AC01 calcium sensitizing heart failure treatment
AnaCardio AB (Sweden), a clinical-stage biopharmaceutical company developing contractile agents for heart failure, and its partner Helsinn Healthcare SA...
FDA Aligns on Accelerated Approval Pathway for NovaBridge's Givastomig in Gastroesophageal Cancer
Clarification: This article concerns a regulatory pathway alignment, not a formal drug approval. The US FDA has not approved givastomig. The source material...
Atara Biotherapeutics and Pierre Fabre seek FDA meeting after tabelecleucel receives CRL
Atara Biotherapeutics, Inc. (Nasdaq: ATRA) announced on March 12, 2026, that a Type A meeting with the US FDA has been scheduled to discuss the Complete...
MetaVia secures global patent portfolio for DA-1726 dual agonist obesity therapy through 2041
MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company headquartered in the US, announced on February 13, 2026, that it has assembled a...
FDA Approves Bristol Myers Squibb's Sotyktu for Active Psoriatic Arthritis in Adults
The US FDA has approved Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis, Bristol Myers Squibb announced on 6 March...
FDA Approves Loargys by Immedica Pharma for Hyperargininemia in Arginase 1 Deficiency Patients
The US FDA has granted accelerated approval to Loargys (pegzilarginase-nbln) for the treatment of hyperargininemia in adult and pediatric patients aged two...
Incyte receives CRL for Zynyz in metastatic lung cancer due to manufacturing facility issues
Incyte Corporation disclosed in a SEC filing dated March 6, 2026, that the US Food and Drug Administration issued a Complete Response Letter on February 27,...
The AllSci Brief
Free, systematic R&D and deal news. Daily.