Indivior Statement RE: Delayed FDA Approval of SUBLOCADE® Label Changes
Indivior PLC (Nasdaq/LSE: INDV) provides the following update regarding its PDUFA action date for label changes (rapid initiation protocol and alternative injection sites) for SUBLOCADE® ...
Pharm Exec8d
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 ...
Pharm Exec21h
FDA Approves AbbVie’s Emblaveo for Complicated Intra-Abdominal Infections
Emblaveo marks the first and only fixed-dose intravenous monobactam/β-lactamase inhibitor combination antibiotic to be ...
Pharmaceutical Technology5h
Travere takes rare disease kidney drug to FDA despite failed trial
Travere’s stock price climbed by 14% following the announcement it will seek an FDA label expansion for Filspari.
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 Oncology6d
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 ...
The American Journal of Managed Care11d
FDA Approves First HER2-Ultralow Companion Diagnostic, Expanding Treatment Eligibility
Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...
Vertex Pharma Stock Surges After FDA Approves Non-Opioid Pain Drug
Analyst is bullish on Vertex Pharmaceuticals, citing FDA approval for JOURNAVX and strong earnings growth potential in 2025.
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 ...
Managed Healthcare Executive11d
FDA Approves Journavx, New Nonopioid Med, for Acute Pain
The FDA recently approved Vertex Pharmaceuticals Incorporated’s Journavx (suzetrigine), a first-in-class non-opioid ...
SpringWorks shares rise on FDA nod for GOMEKLI
Shares of SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) climbed 2.7%, building on a previous gain of 2%, following the FDA ...
Daily Voice Tolland County CT on MSN11d
FDA Approves First Non-Opioid Painkiller In 20+ Years: 'A Historic Milestone'
The Food and Drug Administration has approved a first-of-its-kind non-opioid pain medication, providing a new option for ...