Afrezza hopes that its inhalable insulin product will be a gamechanger for diabetics. (Image courtesy Afrezza). Insulin injections may soon be a thing of the past if Mannkind Corp.'s inhalable insulin product, Afrezza, is approved by ...
Salix Pharmaceuticals and Pharming Group have announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) Action Date to 16 July 2014 for the Biologics License Application (BLA) for the ...
Tags: Drug, Pharming Group
Takeda Pharmaceutical Company Limited ("Takeda") and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that the United States (U.S.) Food & Drug Administration (FDA) has extended the Prescription Drug User ...
Tags: Takeda Pharmaceutical Company Limited, Prescription Drug User Fee Act
QRxPharma, an Australian-based commercial-stage specialty pharmaceutical company, has resubmitted its MOXDUO new drug application (NDA). At a meeting in early October 2013, the US Food and Drug Administration (FDA) provided QRxPharma with ...
Tags: QRxPharma, Drug Application
US-based BioMarin Pharmaceutical has announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted in favor of approval of Vimizim for the treatment of Morquio A ...
The US Food and Drug Administration (FDA) has accepted for review US-based biopharmaceutical firm NPS Pharmaceuticals' supplemental new drug application (sNDA) for Gattex (teduglutide [rDNA origin]) for injection. In the US, Gattex is ...
Tags: FDA, biopharmaceutical
Amarin, a biopharmaceutical company, has announced the outcome of the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee for the use of Vascepa (icosapent ethyl) capsules in the treatment of high ...
AMAG Pharmaceuticals has received a notice of three-month extension from the US Food and Drug Administration (FDA) for a supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection to be used for intravenous (IV) therapy. ...
Tags: AMAG Pharma, Intravenous Use
The Pulmonary-Allergy Drugs Advisory Committee (PADAC) of the US Food and Drug Administration (FDA) has recommended the approval of GlaxoSmithKline (GSK) and Theravance's umeclidinium/vilanterol as a treatment for chronic obstructive ...
Tags: Health, Medicine, Investigational Copd Drug
The US Food and Drug Administration (FDA) has scheduled a meeting on 03 October 2013 to discuss QRxPharma's Moxduo new drug application (NDA) for the treatment of moderate to severe acute pain. The meeting is aimed at focusing on ...
Tags: Acute Pain Drug
The US Food and Drug Administration (FDA) has accepted for review the complete response submission made by Endo Health Solutions' subsidiary Endo Pharmaceuticals to the new drug application (NDA) for its testosterone undecanoate injection ...
Tags: Aveed Injection, Medicine
Biopharmaceutical company Gilead Sciences has obtained priority review status for Sofosbuvir new drug application (NDA) from the FDA for the treatment of hepatitis C infection (HCV). The investigational product is an oral nucleotide ...
Tags: Gilead, Sofosbuvir NDA
Cubist Pharmaceuticals has received the US Food and Drug Administration (FDA) fast track status for its late-stage antibiotic candidate ceftolozane/tazobactam in the previously granted Qualified Infectious Disease Product (QIDP) ...
Tags: Cubist, Fast Track Status
The US Food and Drug Administration (FDA) has accepted to review Antares Pharma's new drug application (NDA) of OTREXUP, designed for the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis. OTREXUP ...
Delcath Systems has submitted its proprietary chemosaturation delivery system's new drug application (NDA) to the US Food and Drug Administration (FDA). The application includes the use of chemosaturation system along with melphalan ...
Tags: FDA, NDA, medical application