The US Food and Drug Administration announced Thursday that it will be phasing out a requirement that monoclonal antibodies ...

When FOX 5 asked those in Greenbelt about the measure Wednesday morning, one man said he understood the use of medical marijuana or prior use coming up on a drug ... out of the application process." ...

The FDA issued a complete response letter for the resubmission of the reproxalap new drug application for the treatment of ...

(Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company focused on immunology and inflammation, today announced in addition to developing TH104 for the proposed ...

Specialty pharmaceutical company PharmaTher Holdings’ drug application for Ketamine has received a June ... “I am very pleased with the new FDA approval goal date of June 4, 2025, for our Ketamine ...

The Pre-Investigational New Drug Application (IND) Consultation Program fosters early communications between sponsors and new drug review divisions to provide guidance on the data necessary to warrant ...

has accepted its New Drug Application (NDA) resubmission for YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with ...

(RTTNews) - Milestone Pharmaceuticals (MIST) announced the FDA issued a Complete Response Letter regarding its New Drug Application for CARDAMYST nasal spray, a prescription medication in ...