STATOpinion

I’m a rare disease mom, and I finally have new hope for my son’s future

For too long, the promise of personalized therapies has been tantalizingly close, yet frustratingly out of reach for ...
Healio

FDA accepts supplemental NDA for phentolamine in presbyopia

The FDA accepted a supplemental new drug application to expand the indication for Ryzumvi to include the treatment of ...
Conventus Law

India – Medical Device As Software: Has CDSCO Guidance Changed The Rules?

Summary: The CDSCO’s Draft Guidance on Medical Device Software only clarifies how the existing Medical Devices Rules apply to software across its lifecycle, but does not create any new regulatory ...
Dark Reading

Trump Administration Rescinds Biden-Era Software Guidance

The White House's Office of Management and Budget (OMB) has issued a memorandum to roll back software security requirements established by the previous administration, including following NIST ...
FierceBiotech

FDA outlines draft policy on MRD, complete response for accelerated approvals in multiple myeloma

After a short delay and concerns of potential intervention from senior officials, the FDA has issued a draft guidance for the industry on the potential use of minimal residual disease (MRD) and ...
Seeking Alpha

Legend Biotech Arcellx rise after FDA draft guidance on multiple myeloma trials

Arcellx (ACLX) and Legend Biotech (LEGN) traded higher on Tuesday after the U.S. FDA issued draft guidance on the use of minimal residual disease and complete response as study endpoints that can ...
TechCrunch

BioticsAI, which won Disrupt’s Battlefield competition in 2023, gains FDA approval for its AI-powered fetal ultrasound product

TechCrunch Disrupt Battlefield 2023 winner BioticsAI announced on Monday that it has received FDA clearance for its AI software that helps detect fetal abnormalities in ultrasound images. The product ...
Reuters

Schrodinger to offer Eli Lilly's AI drug discovery platform on its software

Jan 9 (Reuters) - Schrodinger (SDGR.O), opens new tab said on Friday it is collaborating with Eli Lilly (LLY.N), opens new tab to offer the pharmaceutical major's AI-based platform, TuneLab, on its ...
The National Law Review

Ringing in the New Year with Digital Health- FDA Updates Guidance Documents on Clinical Decision Support Software and General Wellness Products

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
Reuters

US FDA to limit regulation of health and fitness wearables, commissioner says

Jan 6 (Reuters) - The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed to support healthy lifestyles, issuing new guidance to ...
STAT

FDA announces sweeping changes to oversight of wearables, AI-enabled devices

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. Mario Aguilar covers technology ...