Sandoz Receives FDA Approval for Biosimilar HyrimozTM

October 31, 2018 Vijay Soni 0

Sandoz Receives FDA Approval for Biosimilar HyrimozTM By: Novartis News Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar, HyrimozTM (adalimumab-adaz). The FDA granted approval for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) in patients [..]

Libtayo® Received FDA Aproval As First And Only Treatment For Second Most Common Skin Cancer

September 30, 2018 Vijay Soni 0

Libtayo® Received FDA Aproval As First And Only Treatment For Second Most Common Skin Cancer Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Libtayo® (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery [..]

FDA Approved the First and Only Therapy for the Treatment of Mycobacterium Avium Complex (MAC) Lung Disease

September 30, 2018 Vijay Soni 0

FDA Approved the First and Only Therapy for the Treatment of Mycobacterium Avium Complex (MAC) Lung Disease Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of ARIKAYCE® (amikacin liposome inhalation suspension) for the [..]

FDA Approved First siRNA Based New Class of Drug for a Rare Genetic Disease

August 10, 2018 Vijay Soni 0

FDA Approved First siRNA Based New Class of Drug for a Rare Genetic Disease By: Alnylam News Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the United States Food and Drug Administration (FDA) approved ONPATTRO™ (patisiran) lipid complex injection, a first-of-its-kind RNA interference (RNAi) therapeutic, for the treatment [..]

New Era for Migraine Patients: EU Approved Aimovig® of Novartis

August 1, 2018 Vijay Soni 0

New Era for Migraine Patients: EU Approved Aimovig® of Novartis   Novartis announced that the European Commission (EC) approved Aimovig® (erenumab) for the prevention of migraine in adults experiencing four or more migraine days per month. Aimovig is the first and only treatment specifically designed for migraine prevention to be approved [..]

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 [..]