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Apr 24, 2026
The EMA’s CHMP recommended approval of Sanofi’s Cenrifki (tolebrutinib) for non-relapsing secondary progressive multiple sclerosis. The phase 3 HERCULES study showed reduced disability progression, while liver injury remains an identified safety risk.
Apr 14, 2026
The FDA approved an updated Vabysmo label for macular edema following retinal vein occlusion beyond six months. The decision extends treatment based on data showing visual acuity gains and central subfield thickness reductions maintained through week 72.
Apr 24, 2026
The Trump administration moved to reclassify marijuana from Schedule I to Schedule III under the Controlled Substances Act. The change is expected to ease research restrictions but will not immediately legalize marijuana.
Apr 24, 2026
The FDA reversed course and said it would review Moderna’s application for a new mRNA-based flu vaccine. The move followed growing concern about federal vaccine policy and came after HHS canceled nearly $500 million in mRNA vaccine contracts.
Apr 23, 2026
The FDA’s publication of complete response letters has tightened company disclosure around drug rejections and exposed common approval hurdles. Analyses of the letters point to frequent facilities and product quality deficiencies and delays averaging more than 2.5 years to final approval.
Apr 23, 2026
The FDA accepted Hansa Biopharma’s BLA for imlifidase and set a PDUFA action date of Dec. 19, 2026. The filing is backed by Phase 3 ConfIdeS data showing statistically significant efficacy.
Apr 23, 2026
A $3.2 million research collaboration is developing a drug that directly breaks down MDM2 in triple-negative breast cancer. Early laboratory models showed tumour shrinkage, and the team is studying dosing, safety and performance.
Apr 22, 2026
NRx said the FDA issued a positive review letter on its preservative-free ketamine ANDA, requesting only minor administrative changes. The company also received FDA guidance outlining a path to an NDA for NRX-100 using clinical trial data and real-world evidence.
Apr 22, 2026
AsedaSciences signed a commercial agreement with Clyde Biosciences to integrate the CellOPTIQ cardiotoxicity screen into its 3RnD platform. The deal adds a validated in vitro CiPA assay for chemical and drug safety assessment.
Apr 22, 2026
Astellas terminated its phase 1 ASP5502 study in Sjögren’s syndrome as Novartis said the FDA granted breakthrough therapy designation to ianalumab. Novartis plans global regulatory submissions from early 2026 after positive phase III data.
Apr 22, 2026
Adial Pharmaceuticals completed demonstration batch production for AD04, meeting prespecified specifications and matching the prior Phase 2 dissolution profile. The step enables clinical and registration batch production for the planned Phase 3 trial.
Apr 22, 2026
Trump’s April 2, 2026 proclamation imposes Section 232 tariffs of up to 100% on patented pharmaceutical imports and ingredients. Generic drugs and biosimilars are excluded.
Apr 22, 2026
Ascentage Pharma said six clinical abstracts were selected for ASCO 2026 and four preclinical studies will be presented at AACR 2026. The presentations feature olverembatinib and other pipeline candidates.
Apr 22, 2026
PARP inhibitors remain strongest in BRCA1/2-altered tumors as use beyond that group has been uneven. In June 2025, the FDA narrowed Zejula’s first-line ovarian maintenance indication to HRD-positive tumors only.
Apr 22, 2026
mRNA cancer vaccines showed promising pancreatic cancer trial results and boosted tumor-fighting drugs in other research. U.S. officials canceled $500 million in vaccine funding, while the NCI is backing a $200 million cancer vaccine partnership.
Apr 21, 2026
The FDA said uniQure’s Phase I/II data for Huntington’s disease gene therapy AMT-130 are not adequate for a marketing application. The agency recommended a new randomised, double-blind, sham surgery-controlled study.
Apr 21, 2026
BridgeBio Oncology Therapeutics said Bbo-11818 received FDA Fast Track designation for adult patients with advanced KRAS-mutated pancreatic ductal adenocarcinoma. The status may accelerate development and review and allow more frequent FDA communication during clinical trials.
Apr 21, 2026
Wafik S. El-Deiry highlighted p53 research and the August 2025 approval of dordaviprone/modeyso, the first treatment for diffuse gliomas with H3K27M mutations. Separate posts also described glioblastoma precision oncology discussions and a lifetime achievement award in Mumbai.
Apr 20, 2026
LENZ Therapeutics submitted a UK marketing authorization application for VIZZ for presbyopia on April 20, 2026. The filing follows FDA approval in July 2025 and EMA validation in March 2026.
Apr 21, 2026
A securities class action alleges Corcept misled investors about the regulatory prospects for relacorilant. The suit cites an FDA Complete Response Letter, a 50.4% stock drop, and an April 21, 2026 lead plaintiff deadline.
