Dive Brief: ProQR Therapeutics is overhauling its research, cutting staff and trying to find a new way forward for its lead drug after a surprising …
Dive Brief: Halozyme Therapeutics, a San Diego-based company whose business revolves around a type of drug delivery technology, announced Wednesday plans to expand its offerings …
Dive Brief: The Food and Drug Administration has cleared Gilead to restart some trials testing an experimental cancer drug the company acquired in a roughly …
Medicare will not pay for Biogen’s new Alzheimer’s medicine unless prospective patients are enrolled in a clinical trial, the U.S. government said Thursday in a …
Dive Brief: Akebia Therapeutics will lay off 42% of its workforce after the Food and Drug Administration last month rejected its most advanced experimental drug, …
Dive Brief: Pfizer said Thursday it will spend as much as $525 million to buy the privately held biotech ReViral, adding experimental treatments for respiratory …
Dive Brief: The Food and Drug Administration has approved the first drug to treat an ultra-rare cluster of conditions caused by mutations in a specific …
Dive Brief: The Food and Drug Administration rejected an Akebia Therapeutics’ anemia pill vadadustat, the company announced Wednesday, over concerns the drug isn’t as safe as currently …
By a slim margin, advisers to the Food and Drug Administration have concluded that the agency should hold off approving a closely watched, experimental medicine …
The drug’s beginnings, according to the two former students there to see them, were quite humble. About a decade ago, Justin Klee and Josh Cohen …
Dive Brief: A drug combination including the Roche immunotherapy tiragolumab failed a Phase 3 trial in a tough-to-treat form of lung cancer, a setback for …
Dive Brief: Adagio Therapeutics said it will ask the Food and Drug Administration for emergency authorization of its COVID-19 drug after announcing Wednesday that the antibody …
Dive Brief: Vertex will begin late-stage testing of one of its top drug prospects later this month, announcing on Tuesday plans for a Phase 2/3 …
Dive Brief: Pfizer said Wednesday an experimental drug central to its $7 billion purchase of Arena Pharmaceuticals succeeded in a crucial Phase 3 trial in …
Dive Brief: Novartis has won Food and Drug Administration approval to sell a radiopharmaceutical designed to treat a form of advanced prostate cancer in a …
If a drug delivery device fails a design verification test, the consequences can be far-reaching. If, for example, the volume of drug being delivered does …
Dive Brief: Shares in Nektar Therapeutics fell by more than half Monday morning after the San Francisco biotech company and partner Bristol Myers Squibb disclosed …
Sanofi and its development partner, the Swedish drug company Sobi, said Wednesday they plan to submit an experimental, longer-lasting hemophilia treatment for approval now that …
Dive Brief: After receiving a rejection last year, Acadia said Wednesday that the Food and Drug Administration agreed to review its resubmitted application to expand …
In a State of the Union address Tuesday night, President Joe Biden highlighted the country’s need for quality mental health services and called for action …
