USFDA

Aduro Biotech, Inc. ,a biopharmaceutical company with three distinct immunotherapy technologies,  announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on its clinical trials evaluating the LADD (live, attenuated double-deleted) immunotherapy platform, enabling patient enrollment to resume in all Aduro-sponsored clinical studies.

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Amplyx Pharmaceuticals, a company developing novel antifungal agents for life-threatening fungal infections, announced  that the U.S. Food and Drug Administration (FDA) Office of Orphan Product Development has granted orphan drug designation to APX001, the company’s lead drug candidate. APX001 has received orphan drug designation for four distinct indications: the treatment of invasive candidiasis, invasive aspergillosis, coccidioidomycosis, and rare mold infections caused by Scedosporium spp., Fusarium spp., and Mucorales fungi (including Mucor spp., and Rhizopus spp.).

Cellnovo Group announces  that it has filed for 510(k) approval with the US Food and Drug Administration (FDA) for marketing clearance of the Company's diabetes management system.

Novartis announced that the US Food and Drug Administration (FDA) granted Priority Review to the PKC412 (midostaurin) new drug application (NDA) for the treatment of acute myeloid leukemia (AML) in newly-diagnosed adults with an FMS-like tyrosine kinase-3 (FLT3) mutation, as well as for the treatment of advanced systemic mastocytosis (SM). The premarket approval application (PMA) for the PKC412 (midostaurin) FLT3 companion diagnostic, developed in collaboration with Invivoscribe Technologies, Inc. (IVS)* has also been accepted for review by the FDA. Outside the US, the marketing authorization application for PKC412 (midostaurin) in these indications has already been accepted by the European Medicines Agency (EMA).

Dynavax Technologies Corporation announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for immunization of adults 18 years and older against hepatitis B infection. The FDA issues CRLs to communicate that the Agency has completed a review cycle of an application and to request additional information for review and approval. Dynavax expects a Class 2 designation for a resubmission of the BLA, which would result in a target review period of six months.

Silicon Valley medical device innovator CapsoVision, Inc. is pleased to announce that they have received U.S. Food and Drug Administration (FDA) 510(k) clearance for the CapsoCam® Plus small bowel capsule endoscope system.

Bristol-Myers Squibb Company  announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. Opdivo is the first and only Immuno-Oncology treatment proven in a Phase 3 trial to significantly extend overall survival (OS) for these patients. In oncology clinical trials, OS is considered the gold standard primary endpoint to evaluate the outcome of any therapy.

Gilead Sciences, Inc. announced that the US Food and Drug Administration (FDA) has approved Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease.

Seattle Genetics  Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ADCETRIS (brentuximab vedotin) for the treatment of patients with CD30-expressing mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) who require systemic therapy and have received one prior systemic therapy. MF and pcALCL are the most common subtypes of cutaneous T-cell lymphoma (CTCL), accounting for more than 75 percent of the disease.

Emmaus Life Sciences, Inc., announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application for its orally administered pharmaceutical grade L-glutamine (PGLG) treatment for sickle cell disease.

Data from the company's Phase 3 sickle cell disease trial demonstrated a reduction in the frequency of sickle cell crises and hospitalizations, as well as a reduction in cumulative days hospitalized, and a lower incidence of the life-threatening acute chest syndrome.