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FDA
On Wednesday, the FDA approved Merck’s pneumococcal 15-valent conjugate vaccine for children 6 weeks through 17 years of age.
Galapagos announced that it had acquired CellPoint and AboundBio in an all-cash transaction, greatly expanding its drug portfolio.
Novartis’ win in the patent dispute over its drug, Gilenya, was short-lived after a U.S. appeals court reversed its 2020 ruling vs. HEC Pharm’s attempt to create a generic version.
CRISPR Therapeutics could be on the cusp of achieving a first in gene therapy, the first company to achieve regulatory approval for a CRISPR-Cas9 program.
TC BioPharm is developing a new approach to chimeric antibody receptor (CAR) T-cell therapies with the potential to eliminate off-target effects, and possibly help more patients.
Halberd Corporation spins off new subsidiary to take unconventional approach to cancer treatment.
Decentralized clinical trials may cost more upfront, but can have huge returns on the back end, according to speakers at Informa Connect’s Decentralized Clinical Trials meeting.
9 Meters Biopharma is discontinuing a Phase III clinical trial for larazotide, a treatment for celiac disease as interim results were not statistically significant.
Acer Therapeutics and Relief Therapeutics announced the FDA has denied their NDA for ACER-001 (sodium phenylbutyrate) for the treatment of urea cycle disorders.
Despite the refutation of research articles by Piero Anversa, they continue to serve as a basis for funding requests from scientists who hope to prove that the heart can regenerate cardiac muscle.
Mark Cuban Cost Plus Drug Company now boasts over 700 prescription generic drugs for a variety of conditions, ranging from acid reflux to dementia to autoimmune diseases like Rheumatoid Arthritis.
Three physicians filed a lawsuit against the FDA alleging the organization acted outside its authority and with their ability to practice medicine by discouraging the use of ivermectin to treat COVID-19.
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