EPIDIOLEX®:First FDA-approved Drug Derived From Marijuana

July 17, 2018 Vijay Soni 0

EPIDIOLEX®:First FDA-approved Drug Derived From Marijuana GW Pharmaceuticals plc (Nasdaq: GWPH, “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its U.S. subsidiary Greenwich Biosciences, announced today that the U.S. Food and Drug Administration [..]

FDA Approves TPOXX® :The First Drug For Smallpox

July 17, 2018 Vijay Soni 0

FDA Approves TPOXX® :The First Drug For Smallpox SIGA Technologies, Inc. (SIGA) (NASDAQ:SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced that the U.S. Food and Drug Administration (FDA) has approved oral TPOXX® (tecovirimat) for the treatment of smallpox to mitigate the impact of a potential outbreak. TPOXX, a small-molecule [..]

FDA Grants Priority Review to Genentech’s Cancer Immunotherapy Tecentriq

May 7, 2018 Vijay Soni 0

FDA Grants Priority Review to Genentech’s Cancer Immunotherapy Tecentriq 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 accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for TECENTRIQ® (atezolizumab), in combination [..]

Novartis Receives Second FDA Approval for Kymriah® to Treat B-cell Lymphoma

May 2, 2018 Vijay Soni 0

Novartis Receives Second FDA Approval for Kymriah® to Treat B-cell Lymphoma By: Novartis News Novartis today announced the US Food and Drug Administration (FDA) has approved Kymriah® (tisagenlecleucel) suspension for intravenous infusion for its second indication – the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two [..]

U.S. FDA Approved ERLEADA™ for Prostate Cancer

February 28, 2018 Vijay Soni 0

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

February 18, 2018 Vijay Soni 0

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

February 13, 2018 Vijay Soni 0

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

February 12, 2018 Vijay Soni 0

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

January 26, 2018 Vijay Soni 0

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

January 25, 2018 Vijay Soni 0

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®

January 7, 2018 Vijay Soni 0

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)

January 7, 2018 Vijay Soni 0

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

December 28, 2017 Vijay Soni 0

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 [..]

FDA Approves Sanofi-Aventis’s Admelog to Treat Diabetes: The First Short-Acting “Follow-On” Insulin Product

December 17, 2017 Vijay Soni 0

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 [..]

U.S. FDA Approves Mylan and Biocon’s Ogivri™, for HER2-Positive Breast and Gastric Cancers

December 6, 2017 Vijay Soni 0

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

December 6, 2017 Vijay Soni 0

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

November 28, 2017 Vijay Soni 0

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

November 28, 2017 Vijay Soni 0

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

November 21, 2017 Vijay Soni 0

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

November 20, 2017 Vijay Soni 0

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 [..]