Researchers have identified distinct immune responses driving checkpoint myocarditis, a severe heart inflammation linked to cancer immunotherapy.

Sarepta Therapeutics halts development of vesleteplirsen (SRP-5051), a more potent follow-up to Exondys 51 for Duchenne muscular dystrophy (DMD).

The FDA has extended the review period for Novartis' ofatumumab, a potential treatment for multiple sclerosis, with a decision now expected in September.

The FDA has approved Blincyto (blinatumomab) for adult and pediatric patients with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase.

A comprehensive study across multiple clinics in the U.S. and Europe has confirmed the efficacy of ulipristal acetate as an emergency contraceptive, showing a significant reduction in pregnancy rates when administered within 48 to 120 hours after unprotected intercourse. The study also compared its effectiveness and safety profile with levonorgestrel, another emergency contraceptive, finding ulipristal acetate to be non-inferior and well-tolerated.

A new study indicates that Paxlovid, an antiviral treatment for COVID-19, may significantly lower the risk of developing long COVID. The research, which analyzed medical records of over 56,000 patients, found that those who took Paxlovid within five days of diagnosis had a 26% lower risk of long-term symptoms. The study also highlights the drug's effectiveness across different vaccination statuses and its potential to reduce hospitalizations and deaths.

Biogen has announced its acquisition of Human Immunology Biosciences (HI-Bio) for $1.15 billion in cash, with potential additional payments of up to $650 million based on milestones. This move aims to diversify Biogen's pipeline, traditionally focused on neurology, by adding HI-Bio's lead drug, felzartamab, which has completed Phase 2 trials for kidney conditions. The acquisition is part of Biogen's strategy to reduce pipeline risk and explore new therapeutic areas under CEO Chris Viehbacher's leadership.

Roluperidone, currently in Phase 3 trials, offers hope for treating schizophrenia's negative symptoms by blocking serotonin rather than dopamine.

Morepen Laboratories has received regulatory clearance from India's CDSCO to conduct bioequivalence studies for Resmetirom tablets in three dosage strengths (60mg, 80mg, 100mg) for treating non-alcoholic steatohepatitis.

A new NIH-funded study will investigate why some cancer treatments cause cardiotoxicity in certain patients but not others, focusing on covalent kinase inhibitors.

The European Medicines Agency's committee has recommended the approval of lecanemab for treating early Alzheimer's disease, reversing its previous rejection.

The European Union's CHMP has recommended the approval of Leqembi for specific patients in the early stages of Alzheimer's disease, potentially marking the EU's first treatment for the condition.

The FDA has extended the review period for Merus' zenocutuzumab, a bispecific antibody targeting NRG1 fusion-positive cancers, to February 4, 2025.

The FDA has extended the target action date for reviewing Organon's supplemental New Drug Application for VTAMA (tapinarof) cream, 1%, to March 12, 2025.

Hanmi Pharm aims to launch efpeglenatide, a GLP-1 receptor agonist, for obesity treatment in late 2026, ahead of the previously projected 2027 timeline.

Hanmi Pharmaceutical has expedited the launch of its anti-obesity drug candidate, efpeglenatide, to the second half of 2026.

LAVA Therapeutics has discontinued the development of LAVA-1207, a novel bispecific gamma-delta T-cell engager for treating PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), due to unmet internal benchmarks in a phase 1/2a trial. Despite this, the treatment showed promise in reducing PSA levels in some patients and will remain available for those currently undergoing treatment. The company is now focusing on other pipeline projects, including LAVA-1266 for acute myeloid leukemia and myelodysplastic syndrome.

Neogap Therapeutics has commenced a Phase I/II clinical trial for its personalized Tumor Trained Lymphocyte (pTTL) therapy in Sweden.

The FDA has extended the PDUFA action date for elamipretide to April 29, 2025, allowing more time to review supplemental data for Barth syndrome treatment.

Ascentage Pharma raised $126.4 million in a U.S. IPO to support late-stage clinical development of olverembatinib and lisaftoclax, aimed at treating CML and CLL, respectively.