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The FDA ordered Avidity Biosciences to halt clinical trial enrollment after a patient suffered a “serious adverse event” testing the company’s candidate drug for myotonic dystrophy type 1.
The FDA has granted a rolling review to CRISPR Therapeutics and Vertex’s exa-cel, a potential one-time treatment for sickle cell disease and transfusion-dependent beta-thalassemia.
During an R&D presentation Tuesday, Transgene executives and oncology experts highlighted promising therapeutic progress in its programs - focusing on its developmental cancer vaccines.
Colossal started the “de-extinction” of the thylacine, commonly known as the Tasmania tiger. Now with a $30 million investment, this technology is gaining more traction.
The U.S. Equal Employment Opportunity Commission filed a lawsuit Monday against Eli Lilly and Co. alleging the company refused to hire older workers for sales representative positions.
Sanofi has inked a licensing deal with Scribe Therapeutics to develop novel natural killer (NK) cell therapies for cancer using Scribe’s CRISPR genome editing technology.
In the ongoing proxy battle between London-based Mereo BioPharma Group and Rubric Capital Management, Mereo outlined the outcome of the most recent negotiations, which Rubric rejected.
MassBioEd partners with developers in Boston to train and employ more workers in a burgeoning Genetown life sciences industry desperate for skilled labor. Meanwhile, Biogen clears real-estate space.
Daiichi Sankyo won approval in Japan for Ezharmia, making it the first dual inhibitor of EZH1 and EZH2 to receive regulatory approval for ATL.
Quality by design principles, when fully optimized, can decouple much of the process from the molecule itself, leading to significant efficiencies.
Equillium, 9 Meters Biopharma and ABVC Biopharma have something to say about lupus, short bowel syndrome and ADHD.
Lipocine will undergo a strategic realignment and focus its drug development program on developing a pipeline of differentiated products for central nervous system disorders.
BioSpace spoke with Saundra Pelletier, CEO of Evofem Biosciences, to discuss the realities of being a woman in the life sciences and find out the career moves that propelled her forward.
In an 8-4 vote, the FDA’s Oncologic Drugs Advisory Committee Roster voted against the benefit-risk profile of Secura Bio’s P13K inhibitor Copiktra (duvelisib).
The announcement follows a subgroup analysis of the Phase III SOLO3 trial which showed patients treated with Lynparza saw a 33% greater risk of death than controls who received standard chemotherapy.
Seagen and LAVA Therapeutics inked a licensing deal for LAVA’s Gammabody platform for solid tumors, which can potentially exceed $700 million.
The FDA might only have two PDUFA dates on the calendar this week, but all eyes in the neurodegenerative disease community will be on the first one: Amylyx’s AMX0035 for ALS.
September 24 is World Cancer Research Day, and September is Childhood Cancer Awareness Month. BioSpace spoke with leaders from three companies tackling pediatric glioma.
Recently published research into repairing nerve damage caused by injury may also pay off in treating some of the most vexing neurodegenerative diseases like Alzheimer’s.
NovoCure announced the launching of a U.S.-based arm to focus on and attempt to grow its glioblastoma (GBM) business and increase its patient population.