Dive Brief: The Food and Drug Administration will convene a panel of experts to review Sarepta Therapeutics’ application for approval of a muscular dystrophy gene …
Dive Brief: An experimental Merck & Co. drug that pairs Keytruda with a new type of immunotherapy did not help people with lung cancer in …
Pfizer’s planned $43 billion acquisition of Seagen will be a major test for the Federal Trade Commission since the monopoly-regulating agency revised its views of …
Three months ago, Japanese pharmaceutical giant Takeda paid a biotechnology startup $4 billion for an experimental drug in one of the largest deals of its …
Dive Brief: Sanofi said Thursday it will cut the prices for its insulin products by as much as 78%, following two of its rivals who …
New Building at Rockford, Illinois site will significantly increase equipment and capacity for injectable biologics and other self-administered therapies PCI Pharma Services (PCI), a …
Though the FDA has long been aware of the risk that some people with breast implants may develop a rare form of T-cell lymphoma—now known …
Laura Perryman, former CEO of neurostimulation device maker Stimwave, was arrested in Florida on Thursday after being accused of running a yearslong scheme to defraud …
Applied Molecular Transport has already sacrificed a lot last year to keep its chronic pouchitis treatment on track—including 40% of its staff and early-stage pipeline …
The FDA’s nascent Safer Technologies Program, or STeP, is getting a major glow-up. Half a decade after first proposing the program—which aims to speed up …
A common treatment for the breathlessness experienced by many people with chronic obstructive pulmonary disease (COPD) relies on the use of a positive-expiratory pressure (PEP) …
A surgical robot system developed by Noah Medical and newly cleared by the FDA is out of this world—or, at least, the current world of …
Just over a year after lining up another $3.4 billion to keep developing new tools and technologies toward its long-standing goal of honing our knowledge …
When Veru swiftly wrapped up a phase 3 trial of its COVID treatment last April, expectations bubbled that the company may be able to pry …
Viz.ai is already an old hand at putting its disease-spotting artificial intelligence algorithms through the FDA review process, having secured the agency’s sign-off for seven …
At the end of 2019, Olympus outlined an updated game plan for its medical device business, directing its focus toward gastrointestinal, urological and respiratory care, …
There are no treatments for aortic stenosis, a heart valve problem afflicting as many as a fifth of people over 65. The only solution is …
Insulet broke new ground in 2021 as its annual revenues surged past the $1 billion mark for the first time—even without a splashy new product …
Nearly two years after submitting its MiniMed 780G insulin delivery system to the FDA for clearance, Medtronic is still awaiting the agency’s nod—though not for …
Destiny Pharma could be in line for $570 million thanks to a new co-development agreement with U.S.-based Sebela Pharmaceuticals for a Clostridium difficile treatment. The …
