Curated news and analysis on clinical trials, drug approvals, and medical research.
Zimbabwe rolled out lenacapavir, a twice-yearly HIV prevention injection, on Thursday for high-risk populations including sex workers and adolescent girls. The donor-supported program will initially reach 46,000 people across 24 sites.
Bristol Myers Squibb faces a steep patent cliff with key drugs losing protection between 2027-2029, but newer products like Cobenfy show promise. The stock trades at less than 10 times earnings with a 4.2% dividend yield.
Eighty-six countries including the US and China signed a declaration calling for secure and trustworthy AI at the five-day AI Impact Summit in New Delhi, though the statement included no concrete regulatory commitments and drew criticism for being too generic.
Long-term data from the QUASAR extension study show TREMFYA® maintained clinical remission in over 80% of ulcerative colitis patients at Week 140, with more than half achieving endoscopic remission and no new safety concerns observed.
Abivax announced novel preclinical and clinical data for obefazimod at ECCO 2026, highlighting anti-fibrotic potential in Crohn's disease, favorable safety profile, and rapid onset of symptomatic relief in inflammatory bowel disease patients.
U.S. military strikes alleged drug trafficking boat in Eastern Pacific, killing three people. The attack brings total deaths from Trump administration boat strikes to 148 since September.
Dr. Reddy's Laboratories secures FDA acceptance for DRL-AB, the first abatacept biosimilar application in the U.S., targeting a market worth $3.7 billion annually and positioning the company for first-mover advantage.
The US FDA has accepted Dr Reddy's Biologics License Application for DRL-AB, a proposed interchangeable biosimilar to Orencia (abatacept) for intravenous infusion, marking the first abatacept biosimilar submission.
Vanda Pharmaceuticals announced FDA approval for BYSANTI tablets to treat Bipolar I manic episodes and schizophrenia in adults. The drug has patent protection extending to 2044 and will be commercially available in Q3 2026.
The FDA has approved BYSANTI (milsaperidone), a new chemical entity for treating bipolar I disorder and schizophrenia in adults. The drug is Vanda's second approval in less than two months and is expected to launch in Q3 2026.
The U.S. Food and Drug Administration has approved Vanda Pharmaceuticals' Bysanti for treating schizophrenia and acute bipolar I disorder. The company expects to launch the drug in the third quarter of 2026.
Savara Inc. announced the FDA has accepted its Biologics License Application for Molbreevi to treat autoimmune pulmonary alveolar proteinosis, granting Priority Review with a PDUFA action date of August 22, 2026.
Savara Inc. announced the FDA has filed for review the BLA for MOLBREEVI to treat autoimmune PAP, granting Priority Review with a PDUFA action date of August 22, 2026. The therapy could become the first approved treatment for this rare lung disease.
New COMP006 phase 3 data shows single-dose COMP360 psilocybin achieved a 3.8-point MADRS reduction in treatment-resistant depression, with results comparable to esketamine pivotal trials and rapid onset of effect.
The FDA has accepted Teva and Medincell's New Drug Application for TEV-'749, a once-monthly subcutaneous olanzapine formulation for schizophrenia treatment that showed no need for post-injection monitoring in Phase 3 trials.
The FDA has accepted Teva and Medincell's New Drug Application for olanzapine extended-release injectable suspension (TEV-'749), a once-monthly subcutaneous treatment for schizophrenia in adults that showed no evidence for post-injection monitoring requirements.
Dr. Reddy's Laboratories has received FDA acceptance for its biosimilar application targeting Bristol-Myers Squibb's Orencia, marking the first U.S. application for an off-patent version of the arthritis treatment that generated $2.7 billion in 2025.
New research reveals semaglutide may directly repair cartilage in osteoarthritis patients, while a separate study raises concerns about SNAC, an ingredient used in oral semaglutide formulations, and its effects on gut health.
Switzerland-based CRISPR Therapeutics stands to benefit from increased Casgevy sales following partner Vertex Pharmaceuticals' fourth-quarter results, with five additional gene-editing therapies in clinical trials targeting larger patient populations.
PDS Biotechnology adopted an amended protocol for its Phase 3 VERSATILE-003 trial, adding progression-free survival as an interim primary endpoint to support potential accelerated approval of PDS0101 in HPV16-positive head and neck cancer.
