Curated news and analysis on clinical trials, drug approvals, and medical research.
The FDA has accepted Hansa Biopharma's Biologics License Application for imlifidase, a desensitization treatment for highly sensitized adult kidney transplant patients with positive crossmatch against deceased donors, with a PDUFA date of December 19, 2026.
The global nuclear medicine equipment market is projected to reach USD 10.00 billion by 2035, driven by rising cancer prevalence, technological advances in hybrid imaging systems, and AI integration in diagnostic workflows.
The FDA approved Tecvayli plus Darzalex Faspro for relapsed or refractory multiple myeloma after at least one prior therapy, and accepted a new drug application for iberdomide plus daratumumab and dexamethasone with a PDUFA date of August 17, 2026.
A Phase 1 trial of azer-cel, a CAR T-cell therapy using donor T-cells to target B-cells, is recruiting patients with progressive multiple sclerosis at eight U.S. sites. Separately, multiple randomized trials are comparing hematopoietic stem cell transplantation against high-efficacy disease-modifying therapies.
The FDA approved Tecvayli plus Darzalex Faspro for relapsed/refractory multiple myeloma in March 2026, and Darzalex Faspro-based quadruplet D-VRd for newly diagnosed transplant-ineligible patients in January 2026.
Children with obstructive sleep apnea face nearly twice the risk of contracting influenza or COVID-19 compared to controls, with increased vulnerability persisting even after adenotonsillectomy, according to a five-year study of over 1 million children.
AbbVie is testing venetoclax in a Phase 2 study for adults with relapsed or refractory Waldenström macroglobulinemia or lymphoplasmacytic lymphoma in Japan, aiming to expand the drug into rare blood cancers.
New clinical trials show single doses of psilocybin and LSD produce significant, lasting reductions in OCD and generalized anxiety disorder symptoms for up to 12 weeks, marking a potential shift from daily medication regimens.
The FDA has placed a partial hold on U.S. enrollment in a Phase 2 trial of del-desiran for myotonic dystrophy type 1, citing preclinical mouse data showing blood pressure drops not seen in humans, following a serious adverse event in earlier testing.
Pfizer reported positive Phase 3 trial results for BRAFTOVI combination therapy in metastatic colorectal cancer and received FDA Priority Review for HYMPAVZI expansion to hemophilia patients including children.
Two gene therapies for inherited eye diseases have progressed to clinical trials, with the FDA clearing Sanaregen's SVT-001 for Familial Drusen and SpliceBio treating its first patient in a Stargardt disease trial in Oxford.
New treatments for rare pediatric neurological conditions show promise, with zorevunersen reducing seizures in Dravet syndrome patients and an SMA therapy under FDA review following stem cell research breakthroughs.
The global biosimilar market is experiencing robust growth, valued at USD 36.79 billion in 2024 and projected to reach USD 282.3 billion by 2035 at a CAGR of 20.35%, driven by patent expirations, cost pressures, and expanding access to biologic therapies.
Protagonist Therapeutics reported fourth quarter and full year 2025 financial results, with two NDAs submitted and multiple Phase 3 trials advancing. The company holds $646 million in cash and expects regulatory decisions in 2026.
Altimmune's pemvidutide received FDA Breakthrough Therapy Designation for MASH treatment, with Phase 3 trial initiation planned for 2026. The company raised $75 million in January 2026 to fund development.
Zealand Pharma reported full-year 2025 revenue of DKK 9.2 billion, bolstered by a significant upfront payment from Roche. The company ended the year with DKK 15.1 billion in cash and set 2026 operating expense guidance between DKK 2.72 billion and DKK 3.3 billion.
The FDA has placed a partial clinical hold on PepGen's Phase 2 FREEDOM2-DM1 trial for myotonic dystrophy type 1, citing questions about preclinical pharmacology and toxicology studies. The company is submitting additional analyses to address the FDA's concerns.
Medicus Pharma reported Phase 2 SKNJCT-003 topline data showing 73% clinical clearance and 40% histological clearance at Day 57 in the 200μg cohort. Separately, the FDA cleared the company to begin a Phase 2b dose optimization study for Teverelix in advanced prostate cancer.
The cardiovascular biologics market is projected to reach $4.23 billion by 2033, while the cell therapy market is expected to reach $5.38 billion by 2032, driven by RNA-based therapies and regulatory approvals.
CSPC Pharmaceutical Group has received approval from China's National Medical Products Administration to begin clinical trials for three drug candidates: a hemophilia A biosimilar, a long-acting pain medication, and an injection designated SYH9089.
