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Ahead of a scheduled Advisory Committee meeting this week, the FDA released favorable remarks about the Pfizer-BioNTech and Moderna COVID-19 vaccines for children under the age of five.
While a handful of companies have dominated the COVID-19 vaccine market in the U.S. and Europe, a number of biotechs are continuing to develop vaccines to use as booster shots.
The approval of AMX0035, which will be marketed under the brand name Albrioza, marks the first new ALS drug approved in Canada since 2018.
Genmab’s Phase II expansion cohort of the EPCORE NHL-1 clinical trial revealed that its investigational bispecific antibody epcoritamab induced a durable response in patients with LBCL.
CRISPR Therapeutics shared positive initial data from its Phase I COBALT-LYM trial of CTX130 for cancer which demonstrated safety and efficacy when used to target CD70.
Horizon Therapeutics’ Bill Rees spoke to BioSpace about the scientific discovery and collaboration potential of its new Rockville, Maryland site, which is expected to open in 2024.
SPACs – special purpose acquisition companies – have lost their luster and may never regain it. BioSpace spoke with Neal Gerber Eisenberg’s Gregory D. Grove.
For the second straight day, the FDA’s Cell, Tissue and Gene Therapies Advisory Committee voted unanimously to approve a bluebird lentiviral vector (LVV) gene therapy.
Researchers from all around the world have been working on mapping human genes to their functions. Now, for the first time, that mapping has been completed.
Cogent Biosciences shared its Phase II APEX clinical trial on bezuclastinib for patients with AdvSM and showed promise in treating the rare blood disorder.
The House of Representatives voted on a bill that would give the U.S. Food and Drug Administration more power to ensure biopharma companies run large follow-up trials to confirm accelerated approvals.
AbbVie announced Friday that its investigational drug navitoclax, when used together with ruxolitinib, eases symptoms in myelofibrosis patients who had not yet been treated with a JAK inhibitor.
