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- Read more about CapsoVision, Inc. Receive FDA 510(k) Clearance for CapsoCam® Plus
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.
- Read more about Bristol-Myers Squibb’s Opdivo® Receive FDA Approval Based on Overall Survival in Head and Neck Cancer
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.
- Read more about US FDA approves Gilead's Vemlidy to treat HBV
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.
- Read more about Seattle Genetics Receives FDA Breakthrough Therapy Designation for ADCETRIS®
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.
- Read more about Emmaus’ NDA for Sickle Cell Disease Accepted for Review by FDA
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.
- Read more about Amryt receive FDA Orphan Drug Designation for Drug used to Treat Acromegaly
Amryt, a clinical-stage specialty pharmaceutical company focused on best-in-class treatments for orphan diseases, is pleased to announce that the U.S. Food and Drug Administration ("FDA") has granted orphan drug designation to the Company's drug compound, AP102, which has the potential to treat patients with acromegaly. Acromegaly is a rare endocrine disorder in which the body produces excessive growth hormone, leading to abnormal growth throughout the body over time.
- Read more about U.S.FDA accept Kedrion Biopharma and Kamada’s BLA for Human Rabies Immunoglobulin therapy
Kedrion Biopharma, and Kamada Ltd, two leading human-derived protein therapeutics companies, announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for a human anti-rabies immunoglobulin (IgG) therapy. Rabies is a life-threatening condition that impacts approximately 40,000 people in the U.S. each year. At present, U.S. healthcare professionals have only two rabies IgG therapy options from which to select in preventing the onset of rabies in someone who may have been exposed to the deadly virus.
- Read more about Amgen's Enbrel gets US FDA nod to treat children with chronic moderate-to-severe plaque psoriasis
Amgen announced that the US Food and Drug Administration has approved the supplemental Biologics License Application (sBLA) for the expanded use of Enbrel (etanercept), making it the first and only systemic therapy to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque psoriasis.
- Read more about FDA Approve lupin’s Generic Ortho Cyclen® 28 Tablets
Pharma Major Lupin Limited (Lupin) announced that it has received final approval for Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg from the United States Food and Drug Administration (FDA) to market a generic version of Janssen Pharmaceuticals, Inc.’s Ortho-Cyclen® 28 Tablets (Norgestimate/Ethinyl Estradiol). The approved product will be manufactured at Lupin’s Pithampur facility.
- Read more about FDA Advisory Committee Votes(7-6) to Cempra's Solithromycin
Cempra, Inc. announced that the majority of the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted (7-6) that efficacy results of Cempra's solithromycin outweigh the risks for the treatment of community-acquired bacterial pneumonia (CABP).