Drug Development

FEATURED STORIES
As communication gaps in the US healthcare market widen, the emphasis on the need for credible information and patient empowerment is paramount.
As high prices and supply issues drive consumers to alternative markets for GLP-1s, physicians aren’t too interested in using these therapies to treat conditions like heart disease risk that have existing cheap standards of care.
SpringWorks Therapeutics sprung out of Pfizer’s storeroom, when a rare disease advocacy group pushed to keep a program for neurofibromatosis alive. This method could work for “every rare disease under the sun,” advocates say.
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Milestone Pharmaceuticals hit another bump in the road in its quest to get Cardamyst approved for paroxysmal supraventricular tachycardia when the FDA issued a Complete Response Letter on Friday.
BNT327, a PD L1/VEGF antibody, belongs to a class of next-generation immunotherapies hoping to beat out Keytruda.
Merck’s new formulation of the mega-blockbuster Keytruda, made in collaboration with Alteogen, could help to keep the drug’s patent cliff at bay.
Deloitte urged pharma executives to “be bold” in a new report tracking the top 20 pharmaceutical companies’ R&D performance.
In this episode presented by DIA, BioSpace’s head of insights Lori Ellis discusses the evolution of women’s inclusion in clinical trials with Martin Hodosi, partner at Kearney and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine.
The latest data from Johnson and Johnson’s Rybrevant and Lazcluze lung cancer combo was better than standard of care Tagrisso on overall survival. But analysts say the next step is getting a subcutaneous formula approved.
Several companies will head to the FDA seeking approval of new Duchenne muscular dystrophy treatments next year but the death of a patient taking Sarepta’s Elevidys raises important safety questions.
WVE-N531, an oligonucleotide, elicited significant functional benefit and reversal of muscle damage in the Phase II FORWARD-53 trial. Wave plans to file for accelerated approval of the candidate in 2026.
FDA
Blujepa, which treats UTIs in female patients aged 12 and up with common and uncomplicated infections, will hit the market in the second half of this year.
After years of controversy and allegations of doctored data, Cassava is moving on from Alzheimer’s.