Submission readiness extends beyond content. Early regulatory operations planning supports a compliant, high-quality ...
Regulators say the telehealth company illegally shared patients’ health data with advertisers and misled its customers. Hims ...
Early indicators from a compassionate use plan led analysts to hike projections for daraxonrasib. Elsewhere, Intellia believes it’s answered a key safety question and Arrowhead moved to catch a rival.
Despite another strong earnings report, analysts warned that upcoming cystic fibrosis data from Sionna Therapeutics "looms ...
RNA editing startup Airna is adding more funds to its Series A round, raising another $60 million as it develops genetic medicines for lung, cardiovascular, metabolic and blood diseases. The Boston- ...
The startup is the 12th drug company to bank at least $250 million in an IPO this year, nearly matching totals last seen ...
The company could rival Vertex and Lilly in the burgeoning market for non-opioid, ion-channel-blocking pain drugs. Its ...
An FDA nod mostly clears the way for Orzeyful to enter, by Wall Street estimates, a multibillion-dollar market for drugs that ...
The clearance paves the way for the first preventive flu shot based on mRNA technology and completes a dramatic regulatory ...
Some analysts see warning signs in crucial drug launches from Gilead and Merck, while an important trial readout could change ...
The transaction combines two companies marketing nearly a dozen neurological drugs that bring in steady, but not blockbuster ...
Better-than-expected sales helped Biogen regain the support of investors, while AstraZeneca and GSK worked to convince Wall ...
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