Pharm Exec4d
FDA Approves Expanded Label for Roche's Companion Diagnostic to Identify HER2-Ultralow Breast Cancer Patients Eligible for Enhertu
The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...
Senators warn FDA about Super Bowl commercial believed to mislead patients
A group of Senators has warned the FDA about an ad expected to air during Sunday’s big game that they believe misleads ...
Nasdaq12d
FDA Approves Qelbree Label For ADHD And Lactation
(RTTNews) - Supernus Pharmaceuticals, Inc. (SUPN), a biopharmaceutical company, announced on Monday that the U.S. Food and Drug Administration or FDA has approved an updated label for Qelbree or ...
dvm3604d
Drug label is updated for pain management therapy
Librela (bedinvetmab injection) is a monthly injectable monoclonal antibody, for which real-world drug experience data has ...
FDA approves Qelbree label update for ADHD treatment
ROCKVILLE, Md. - Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a biopharmaceutical company specializing in CNS diseases with an impressive 89% gross profit margin, has announced the FDA approval of a ...
Do food warning labels actually work? Answering your questions.
Readers had a lot to say about my latest column on the Food and Drug Administration’s proposed front-of-package labels. Most ...
JD Supra1d
Finally, FDA’s Final Word on Unapproved Use Communications
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...
Librela U.S. label update ‘better than feared’ for Zoetis, says Morgan Stanley
Morgan Stanley analyst Erin Wright views the latest label change for Librela as “encouraging,” offering vets clarity in prescribing, and while ...
FDA approves Symbravo for acute treatment of migraine in adults
The U.S. Food and Drug Administration has approved Axsome Therapeutics' Symbravo (meloxicam and rizatriptan) for the acute ...
Targeted Oncology3d
FDA Expands PATHWAY HER2 (4B5) Test to Include HER2-Ultralow Status
The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...
Pet drug maker to add death, seizures to warning label on med investigated by Channel 2
ATLANTA — A pet drug maker is making a big change on their labels for their new arthritis shot after Channel 2 Action News ...
With FDA approval, Genentech turns eye implant's focus to diabetes
Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...