USFDA

- Read more about Matinas BioPharma Get FDA Clearance to Initiate Phase 1 Clinical Study of MAT2501
Matinas BioPharma Holdings, Inc., announced that its Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) is now open and the Company is authorized to initiate a Phase 1 clinical study for investigational drug, MAT2501 (encochleated amikacin), for the treatment of non-tuberculous mycobacterium (NTM) infections, its lead chronic indication.
- Read more about ACADIA Pharmaceuticals Announces FDA Advisory Committee Meeting to Review NUPLAZID™
ACADIA Pharmaceuticals Inc., a biopharmaceutical company announced that the Psychopharmacologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data included in ACADIA’s New Drug Application (NDA) for NUPLAZID™ (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease.
- Read more about Dr. Reddy’s Lab Receives FDA approval for ZEMBRACETMSymTouchTM (sumatriptan succinate) Injection
Dr. Reddy's Laboratories, announced that the U.S. Food and Drug Administration (FDA) has approved ZEMBRACE™SymTouch™ (sumatriptan succinate) injection, a drug-device combination product intended for the treatment of acute migraine episodes, with or without aura, in adults who are inadequately managed with existing treatment regimens. ZEMBRACESymTouch is available as a prefilled, ready-to-use, single-dose disposable autoinjector containing 3 mg of sumatriptan, a selective 5-HT1B/ID receptor agonist. The injection is intended to be given subcutaneously.
- Read more about FDA approves first drug to show survival benefit in liposarcoma
The U.S. Food and Drug Administration approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug. Halaven is marketed by Eisai based in Woodcliff Lake, New Jersey.
- Read more about Sun Pharma launched therapeutic equivalent to Novartis' Gleevec in US
Sun Pharma launched therapeutic equivalent to Gleevec® in the US market. Sun Pharma’s subsidiary received final approval for Imatinib Mesylate from FDA in December 2015.
- Read more about SCYNEXIS, Inc. get FDA fast track and QIDP designations for Intravenous Formulation of SCY-078
Drug development company SCYNEXIS, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted both Fast Track and Qualified Infectious Disease Product (QIDP) designations for the intravenous (IV) formulation of SCY-078, SCYNEXIS' novel antifungal product, for the indications of invasive candidiasis (including candidemia) and invasive aspergillosis. SCYNEXIS is currently conducting a Phase 1 study of the IV formulation of SCY-078 to evaluate the safety, tolerability and pharmacokinetics of single-rising doses. The FDA granted QIDP and Fast Track designations for the oral formulation of SCY-078 for both the treatment of invasive candidiasis and invasive aspergillosis in 2014. The oral formulation is currently in Phase 2 development for both invasive candidiasis and vulvovaginal candidiasis.
- Read more about Lynparza™ (olaparib) granted Breakthrough Therapy designation by US FDA
AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for the oral poly ADP-ribose polymerase (PARP) inhibitor Lynparza™ (olaparib), for the monotherapy treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer (mCRPC) in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (abiraterone or enzalutamide).
- Read more about Abbvie’s Venetoclax receives 3rd Breakthrough Therapy Designation from the FDA
AbbVie , a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the investigational agent venetoclax in combination with hypomethylating agents (HMAs) for the treatment of patients with untreated (treatment-naïve) acute myeloid leukemia (AML) who are ineligible to receive standard induction therapy (high-dose chemotherapy). Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein being developed by AbbVie in partnership with Genentech and Roche.
- Read more about Exelixis announces U.S. FDA Deems NDA sufficiently complete and Grants Priority review for Cabozantinib
Exelixis, Inc. announced that the U.S. Food & Drug Administration (FDA) has determined the company’s New Drug Application (NDA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy to be sufficiently complete to permit a substantive review. The NDA will be considered officially filed 60 days from the date of the completion of the submission, or February 20, 2016. The FDA granted Priority Review to the filing and assigned a Prescription Drug User Fee Act action date of June 22, 2016
- Read more about Merck Receive FDA approval of ZEPATIER™
Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved ZEPATIER™ (elbasvir and grazoprevir) for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection, with or without ribavirin (RBV), following priority review by the FDA.