Latest Biotech News

Biogen won its first global approval in China for felzartamab, a monoclonal antibody for multiple myeloma. The Chinese regulator cleared the therapy for second-line use, to be used alongside...

Bristol Myers Squibb secured the first-in-class FDA nod for Zenbexus, its protein degrader in multiple myeloma. The approval positions CELMoDs (covalent and targeted protein degraders) as a...

Cretostimogene grenadenorepvec delivered high complete response rates in a phase III BOND-003 Cohort C study in BCG-unresponsive, high-risk non–muscle-invasive bladder cancer with carcinoma in...

OraSure withdrew its FDA submission for the InteliQuick CT/NG molecular test, disrupting a planned 2026 launch. In the company’s disclosure, FDA discussions led OraSure to pull the 510(k) and CLIA...

Capricor Therapeutics said it will amend its BLA for deramiocel, seeking approval to improve limb function in Duchenne muscular dystrophy after earlier regulatory setbacks. The update follows the...

BMJ Public Health retracted a controversial study that alleged a link between COVID-19 vaccines and excess mortality after an institutional investigation. The retraction directly targets the...

The British Journal of Cancer issued a retraction of a previously published report describing antitumor activity from the recombinant polypeptide GST-NT21MP in breast cancer. The withdrawn...

A phase III BOND-003 Cohort C report extended evidence for an oncolytic approach in a heavily pretreated bladder cancer population defined by BCG unresponsiveness and carcinoma in situ. In...

PatientRightsAdvocate.org sued the American Medical Association, arguing the AMA does not have valid copyright over CPT codes that providers must use for billing. The lawsuit follows a prior...

A commentary argues that pharma’s AI bottleneck in real-world data analysis is less about model size and more about the semantic layer used to interpret clinical meaning. The piece highlights that...

Bristol Myers Squibb won an FDA accelerated approval for Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj, plus dexamethasone, for adult patients with advanced multiple...

Bristol Myers Squibb’s Zenbexus received first-in-class FDA approval in multiple myeloma, formally positioning the therapy as the lead molecule in the CELMoDs class of cancer drugs. BMS is framing...

Cretostimogene grenadenorepvec delivered strong complete response outcomes in a Phase 3 BOND-003 Cohort C study for high-risk, BCG-unresponsive non–muscle-invasive bladder cancer with carcinoma in...

Capricor said it will amend its biologics license application for deramiocel after the FDA opened a new path via additional data tied to an open-label extension in Duchenne muscular dystrophy. The...

OraSure Technologies withdrew its FDA 510(k) and CLIA waiver submission for the InteliQuick CT/NG point-of-care molecular test after discussions with the agency. The withdrawal will delay...

Fujifilm Biotechnologies moved to scale manufacturing readiness after its Holly Springs, North Carolina commercial-scale cell culture site was selected for the FDA’s PreCheck Pilot Program. The...

Aligned Marketplace secured $20 million in new funding toward an advanced primary care marketplace, led by Venrock in its Series A. The company said it has raised $31 million to date, positioning...

Boulevard Bio emerged from stealth with about $65 million in launch financing to reimagine autoimmune treatment through B cell biology. The New York-based company, backed entirely by Deerfield...

A syndicate backed MapLight with a fresh equity financing package described as supporting its schizophrenia platform, according to a public equity report. The update places MapLight on a path...

Two separate retraction items flagged publication integrity in medicine. BMJ Public Health retracted a controversial paper that alleged a link between COVID-19 vaccines and excess deaths after an...