GlobalData on MSN9d
UFlex receives FDA approval for recycled polyethylene in food packaging
The move marks an advancement in reducing plastic waste and assisting global brands in achieving their sustainability ...
PharmExec11d
FDA’s New Accelerated Approval Draft Guidance
The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...
AFN5d
RFK Jr takes aim at self-GRAS process, but what does it mean in practice?
Proposals to eliminate the self-affirmed GRAS pathway have sent shockwaves through the food industry. But what do they mean ...
What’s really in your food? RFK Jr. wants to close this FDA approval loophole
The U.S. health secretary has vowed to close an FDA loophole that has allowed food companies to self-police the safety of new ...
RedHill Biopharma Ltd.: RedHill Biopharma to Submit FDA-Approved Talicia for UK Marketing Authorisation
RedHill plans to submit UK MAA1 for Talicia for H. pylori infection, using MHRA's2 new fast-track approval process, referencing FDA approval, with potential UK approval ...
Healthcare Dive5d
Dr. Oz stresses need for faster Medicare coverage of new devices during confirmation hearing
Mehmet Oz, President Trump’s pick to lead the CMS, said Medicare beneficiaries should have quicker access to new medical ...
New Food Magazine1d
RFK’s push for food safety reform: experts analyse the debate over GRAS
Explore RFK Jr's push for GRAS reform and its impact on food safety. Experts David Acheson and Dr Darin Detwiler discuss ...
The Manila Times5d
Travere Therapeutics Submits sNDA to FDA for Approval of FILSPARI® (sparsentan) for the Treatment of FSGS
FILSPARI REMS: Due to the risk of hepatotoxicity and embryo-fetal toxicity, FILSPARI is available only through a restricted program called the FILSPARI REMS. Prescribers, patients, and pharmacies must ...
Healio10d
FDA approves Soliris for patients aged 6 years and up with generalized myasthenia gravis
The FDA has approved an expanded indication of Soliris, an IV-administered monoclonal antibody for patients aged 6 years and ...
From cancer vaccines to COPD treatments, these 10 companies are developing innovative medicines
Eli Lilly, Adaptimmune, Aurion Biotech, and ImmunityBio had breakthrough medicines and therapies debut in the past year.
RFK Jr. wants to eliminate FDA’s controversial food additive program. Here’s why that matters
It’s time to revamp the FDA’s “generally recognized as safe,” or GRAS, program that allows companies to add untested ...