JD Supra3d
FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for Nonprescription Use
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...
JD Supra12d
Balancing Safety and Accessibility: FDA Broadens Approval Pathway for Nonprescription Drugs by Finalizing the ‘ACNU’ Rule
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...
MM&M4d
Rx Rundown: Johnson & Johnson, Eli Lilly, the FDA and more
N-Power Medicine, backed by Merck GHI, announced the acquisition of Syapse Holdings. Samsung Biologics and LigaChem extended their ADC services deal. Publicis Worldwide merged with Leo Burnett to form ...
Yahoo29d
FDA approves Zepbound for obstructive sleep apnea
According to drugmaker Eli Lilly, it’s the first and only FDA-approved prescription medication for adults with obstructive sleep apnea. It’s also FDA-approved to treat obesity. Obstructive ...
Nasdaq13d
Petros Pharmaceuticals Positioned To Lead Rx-to-OTC Switch With New FDA Rule
Petros aims to be a innovator in this emerging market by helping companies meet the FDA's requirements for Rx-to-OTC switches. "We are excited to be at the forefront of this emerging sector," said ...
Zawya7d
FDA approves Tirzepatideas: The first and only prescription medicine for moderate-to-severe obstructive sleep apnea in adults with obesity
Averaging up to 20% of weight loss, adults taking Tirzepatide had at least 25 fewer breathing interruptions each hour as they ...