NEWS

Novartis drug Tasigna® approved by FDA to treat children with rare form of leukemia By: Novartis News Novartis announced today that the US Food and Drug Administration (FDA) expanded the indication for Tasigna® (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia [..]

Novartis teams up with Harvard to develop next-generation biomaterial systems to deliver immunotherapies By: Novartis News Novartis announced today that it is teaming up with scientists from the Wyss Institute for Biologically Inspired Engineering at Harvard University and the Dana-Farber Cancer Institute to develop biomaterial systems for its portfolio of [..]

U.S. FDA Approved ERLEADA™ for Prostate Cancer By: Janssen News The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved ERLEADA™ (apalutamide), a next-generation androgen receptor inhibitor,[1] for the treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). ERLEADA™ is the first FDA-approved [..]

FDA Aproved First Diagnostic Blood Test for Traumatic Brain Injury By: Business Wire Banyan Biomarkers, Inc., a pioneer in developing biomarkers for traumatic brain injury (TBI), announced that the U.S. Food and Drug Administration (FDA) has granted the De Novo request for the commercialization of Banyan BTITM (Brain Trauma Indicator), an [..]

Sandoz Announces US FDA Approval and Launch of Glatopa® for Relapsing Forms of Multiple Sclerosis By: Novartis News Sandoz, a Novartis division, today announced the US FDA approval and launch of Glatopa® (glatiramer acetate injection) 40 mg/mL. Glatopa (glatiramer acetate injection) 40 mg/mL is FDA-approved as a fully-substitutable, AP-rated generic version of Copaxone®* (glatiramer [..]

Novartis Receives FDA Approval for Cosentyx® Label Update to Include Moderate-to-Severe Scalp Psoriasis By: Novartis News Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Cosentyx® (secukinumab), the first interleukin-17A (IL-17A) inhibitor approved to treat moderate-to-severe plaque psoriasis[1]. The updated label includes Cosentyx data in moderate-to-severe [..]

FDA Approved Lutathera® of Novartis for Treatment of Gastroenteropancreatic Neuroendocrine Tumors By: Novartis Media Release Novartis AG (NYSE: NVS) today announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and Drug Administration (FDA) approval of its new drug application (NDA) for Lutathera® (lutetium Lu 177 dotatate*) [..]

Novartis exclusively licenses first ophthalmology gene therapy in all markets outside the US, a milestone for patients with rare inherited vision loss By: Novartis Media Release Novartis today announced a licensing agreement with Spark Therapeutics covering development, registration and commercialization rights to voretigene neparvovec in markets outside the US. Voretigene neparvovec, [..]

FDA Granted Breakthrough Therapy Designation to Novartis Kisqali® By: Novartis News Novartis announced Kisqali® (ribociclib) received US Food and Drug Administration (FDA) Breakthrough Therapy designation for initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with [..]

Promacta® of Novartis Receives FDA Breakthrough Therapy Designation for First-Line Use in Severe Aplastic Anemia (SAA) Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Promacta®(eltrombopag) for use in combination with standard immunosuppressive therapy for the treatment of patients with severe aplastic [..]

Novartis drug Tasigna® is approved by FDA For CML  By: Novartis Media Release Novartis announced that the US Food and Drug Administration (FDA) approved the inclusion of Treatment-free Remission (TFR) data in the Tasigna® (nilotinib) US product label. Tasigna is now the first and only BCR-ABL tyrosine kinase inhibitor (TKI) to [..]

First Drug for Eosinophilic Granulomatosis with Polyangiitis (EGPA) of GSK Approved by FDA By: GSK News GlaxoSmithKline plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as the first targeted treatment for eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss syndrome.  GSK [..]

FDA Approves Sanofi-Aventis’s Admelog to Treat Diabetes: The First Short-Acting “Follow-On” Insulin Product By: Sanofi-Aventis News The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Admelog®, the first follow-on insulin lispro to help people living with diabetes manage blood sugar levels at mealtime. “Sanofi has a deep heritage and broad [..]

This New Tool by FDA Will Help Doctors to Better Manage Antibiotic Use By: FDA News The U.S. Food and Drug Administration is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance. [..]

U.S. FDA Approves Mylan and Biocon’s Ogivri™, for HER2-Positive Breast and Gastric Cancers By: PRNewswire HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India,/PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Ogivri™(trastuzumab-dkst), a biosimilar to Herceptin® (trastuzumab), co-developed with Biocon. Ogivri [..]

FDA Grants Full Approval to Genentech’s Avastin  for Brain Cancer By: Genentech News Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has granted full approval for Avastin®(bevacizumab) for the treatment of adults with glioblastoma that progressed following prior [..]

Rxsight’s Light Adjustable Lens Got FDA Approval By: RxSight, Inc. News ALISO VIEJO, Calif., RxSight, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the RxSight™ Light Adjustable Lens and the Light Delivery Device (LDD) for patients with pre-existing astigmatism of ≥ 0.75 diopters undergoing cataract surgery. This [..]

FDA Approved ViiV’s Juluca® For HIV By: ViiV Healthcare News ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, announced that the US Food and Drug Administration (FDA) has approved Juluca®, indicated as a complete regimen for the maintenance treatment of HIV-1 [..]

FDA Approved Pfizer’s Sutent® For Renal Cell Carcinoma By: Pfizer News Pfizer Inc. (NYSE:PFE) announced that the U.S. Food and Drug Administration has approved a new indication expanding the use of SUTENT® (sunitinib malate) to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma [..]

FDA Approved Genentech’s Hemlibra for Hemophilia A By: Genentech News Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved HEMLIBRA® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children [..]

Ultragenyx’s MEPSEVII™ Got FDA Approval NOVATO, Calif., (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved MEPSEVII™ (vestronidase alfa), the first medicine approved for the treatment of [..]

Now You Can Get Your Blood Test Results In Minutes, On-site, With New Sysmex XW-100 : F.D.A. Approved  Sysmex America announced that its Sysmex XW-100 received clearance from the U.S. Food and Drug Administration (FDA)—making it the first Clinical Laboratory Improvement Amendments (CLIA)-waived, complete blood count (CBC) system. Once prepared for each [..]

TransEnterix’s New Robotically-Assisted Surgical Device Is Approved by U.S. FDA TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, announced the Company has received FDA 510(k) clearance for the Senhance™ Surgical Robotic System. “The clearance of the Senhance System in the US [..]

Another Revolutionary Gene Therapy Treatment Approved by U.S. FDA Kite, a Gilead Company, (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has granted regular approval to Yescarta™ (axicabtagene ciloleucel), the first chimeric antigen receptor T cell (CAR T) therapy for the treatment of adult patients with relapsed or refractory large B-cell [..]

FDA Approved Roche’s cobas Zika: First Donor Screening Test for Zika Virus By: Roche Molecular Systems, Inc. News Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the cobas® Zika test for use on the cobas 6800/8800 Systems. The cobas [..]

FDA Approved Respicardia’s Implantable Device to Treat Central Sleep Apnea By: FDA News The U.S. Food and Drug Administration approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea. The Remedē System is an implantable device that stimulates a nerve located in [..]

FDA Awards 15 Grants for Clinical Trials for The Product Development Against Rare Diseases By: FDA News The U.S. Food and Drug Administration announced that it has awarded 15 new clinical trial research grants totaling more than $22 million over the next four years to boost the development of products [..]