New Approvals – Page 19

EU OKs first-line use of Roche’s lung cancer drug Alecensa

Roche’s Alecesna has been cleared for use in Europe as a first-line treatment for ALK-positive non-small cell lung cancer (NSCLC), offering a new option for patients newly diagnosed with the disease.

Source: Pharmatimes
471
December 22, 2017

Pfizer Announces FDA Approval of XELJANZ (tofacitinib) and XELJANZ XR for the Treatment of Active Psoriatic Arthritis

XELJANZ/XELJANZ XR, THE FIRST ORAL JAK INHIBITOR IN THE U.S. FOR ADULTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS, IS NOW APPROVED FOR ADULTS WITH ACTIVE PSORIATIC ARTHRITIS

Source: Pfizer
520
December 21, 2017

DMARDs New Approvals rheumatoid arthritis XELJANZ

FDA rolls out an early and historic OK for Spark’s pioneering gene therapy

Spark Therapeutics $ONCE has scored an historic FDA approval of Luxturna, the world’s first such AAV-delivered gene therapy designed to cure a rare eye disease triggered by a genetic mutation. The drug is OK’d for RPE65 mutation linked retinal dystrophy. The treatment uses a viral vector to insert the correct copy of a gene retinal cells need to create a protein that turns light into electric signals which can restore vision lost to the disease. As with the earlier pioneering approval of the world’s first CAR-T, FDA commissioner Scott Gottlieb did the honors in recognizing the importance of this approval. And he says the agency will make sure that the regulatory path is straight and clear for the rest of the field looking to following Spark’s footsteps. “We’re at a turning point when it comes to this novel form of therapy and at the FDA, we’re focused on establishing ...

Source: drugdu
752
December 20, 2017

FDA genetic mutation. Luxturna New Approvals rare eye disease

US FDA Accepts Regulatory Submission for TAGRISSO (Osimertinib) in 1st-Line EGFR-Mutated Non-Small Cell Lung Cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of TAGRISSO® (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations). The FDA has granted TAGRISSO Priority Review status, and previously granted Breakthrough Therapy Designation for TAGRISSO in the 1st-line treatment of patients with metastatic EGFR mutation-positive (EGFRm) NSCLC.

Source: finance.yahoo
611
December 19, 2017

AstraZeneca CNS FDA New Approvals NSCLC TAGRISSO®

FDA Accepts Biologics License Application for Fremanezumab with Priority Review for Prevention of Migraine and Grants Fast Track Designation for Cluster Headache Development Program

Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraine. Additionally, the FDA has granted fast track designation for fremanezumab for the prevention of cluster headache.

Source: finance.yahoo
570
December 19, 2017

cluster headache FDA fremanezumab migraine New Approvals Teva

Medimetriks Pharmaceuticals, Inc. Receives FDA Approval for Xepi (ozenoxacin) Cream, 1%, a Novel Topical Antibiotic for Impetigo

Medimetriks Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Xepi (ozenoxacin) Cream, 1%, a new chemical entity for the treatment of impetigo in patients two months of age and older when applied topically twice daily for 5 days. In the U.S., impetigo is estimated to account for approximately 10% of skin problems observed in pediatric clinics and is considered the most common bacterial skin infection.

Source: drugs
656
December 18, 2017

FDA impetigo New Approvals skin problems Xepi (ozenoxacin) Cream

New Formulation of ONCASPAR®▼ (pegaspargase) Receives Marketing Authorization in Europe for Patients with Acute Lymphoblastic Leukemia (ALL)

Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in rare diseases, today announced that the European Commission (EC) granted Marketing Authorization for lyophilized ONCASPAR (pegaspargase), as a component of antineoplastic combination therapy in acute lymphoblastic leukemia (ALL) in pediatric patients from birth to 18 years, and in adult patients.1 The approval – which authorizes Shire to market lyophilized ONCASPAR in the 28 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway – follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on October 12.

Source: Shire
607
December 15, 2017

ALL Antineoplastic New Approvals

FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome

The U.S. Food and Drug Administration(FDA) expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body. This new indication provides the first FDA-approved therapy specifically to treat EGPA.

Source: Prnewswire;
487
December 14, 2017

EGPA New Approvals vasculitis

FDA Approves Admelog, the First Short-acting “Follow-on” Insulin Product to Treat Diabetes

The U.S. Food and Drug Administration(FDA) approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Admelog is the first short-acting insulin approved as a “follow-on” product (submitted through the agency’s 505(b)(2) pathway).

Source: fda.gov
600
December 13, 2017

Admelog blood sugar diabetes New Approvals

OTC Viagra– Pfizer snags nod for nonprescription sales of the little blue pill for men in the U.K.

Pfizer has won a first approval for OTC Viagra. Viagra Connect, the Pfizer OTC name for its blockbuster erectile dysfunction drug, has been approved for sale in the U.K.

Source: Fiercepharma
556
December 13, 2017

erectile dysfunction drug New Approvals OTC Viagra Pfizer

EU OKs first-line use of Roche’s lung cancer drug Alecensa

Pfizer Announces FDA Approval of XELJANZ (tofacitinib) and XELJANZ XR for the Treatment of Active Psoriatic Arthritis

FDA rolls out an early and historic OK for Spark’s pioneering gene therapy

US FDA Accepts Regulatory Submission for TAGRISSO (Osimertinib) in 1st-Line EGFR-Mutated Non-Small Cell Lung Cancer

FDA Accepts Biologics License Application for Fremanezumab with Priority Review for Prevention of Migraine and Grants Fast Track Designation for Cluster Headache Development Program

Medimetriks Pharmaceuticals, Inc. Receives FDA Approval for Xepi (ozenoxacin) Cream, 1%, a Novel Topical Antibiotic for Impetigo

New Formulation of ONCASPAR®▼ (pegaspargase) Receives Marketing Authorization in Europe for Patients with Acute Lymphoblastic Leukemia (ALL)

FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome

FDA Approves Admelog, the First Short-acting “Follow-on” Insulin Product to Treat Diabetes

OTC Viagra– Pfizer snags nod for nonprescription sales of the little blue pill for men in the U.K.

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