Approvals

AstraZeneca’s Immunotherapy Drug Wins Key Lung Cancer Approval

February 22, 2018

LONDON, Feb 19 (Reuters) – AstraZeneca’s immunotherapy drug Imfinzi has won crucial approval from U.S. regulators for use in lung cancer, opening up a multibillion-dollar market for a medicine that has so far lagged behind competitors.   The U.S. Food and Drug Administration (FDA) said late on Friday it had granted approval for expanded use […]

FDA Approves Osmotica Pharmaceutical’s Once-Daily OSMOLEX ER™ (amantadine) extended-release tablets for the treatment of Parkinson’s Disease and Drug-Induced Extrapyramidal Reactions in Adults

February 20, 2018

BRIDGEWATER, N.J., Feb. 19, 2018 (GLOBE NEWSWIRE) — Osmotica Pharmaceutical US LLC (“Osmotica” or the “Company”), a privately-held specialty pharmaceutical company developing novel central nervous system (CNS) treatments utilizing its proprietary osmotic drug delivery platform, announced today that the U.S. Food and Drug Administration (FDA) has approved OSMOLEX ER™, an amantadine extended release tablet, for […]

FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing

February 19, 2018

The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation). “This is the first treatment approved for stage III […]

Stallergenes Greer Announces Approval in Japan of Pediatric Use for ACTAIR®, Sublingual Immunotherapy Tablet for the Treatment of House Dust Mite Allergy

February 16, 2018

LONDON–(BUSINESS WIRE)–Regulatory News:   “The approval of ACTAIR for pediatric use in Japan will provide a valuable treatment option for patients under the age of 12 suffering from allergic rhinitis caused by an allergy to house dust mites. We are very pleased that this product will be available to even more patients in Japan” Tweet […]

J&J Gets First-Of-Its-Kind Prostate Cancer Approval

February 15, 2018

Dive Brief: In a first-of-its-kind approval on Wednesday, the Food and Drug Administration approved a treatment based on a new endpoint – metastasis-free survival. Johnson & Johnson’s apalutamide is now indicated for non-metastatic castration-resistant prostate cancer. The drug, approved ahead of its April user fee action date, will be sold under the trade name Erleada. […]

FDA approves first blood test that can help diagnose a concussion

February 15, 2018

The Food and Drug Administration on Wednesday approved a first-ever blood test to detect the telltale signs of serious brain injury, bringing to fruition a long quest to make the diagnosis of concussions simpler and more precise. After deliberations that took less than six months, the FDA approved the marketing of the Banyan Brain Trauma […]

ERLEADA™ (apalutamide), a Next-Generation Androgen Receptor Inhibitor, Granted U.S. FDA Approval for the Treatment of Patients with Non-Metastatic Castration-Resistant Prostate Cancer

February 15, 2018

HORSHAM, Pa., Feb. 14, 2018 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today 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 treatment for these patients. Today’s […]

AMAG Pharmaceuticals Announces FDA Approval of Makena® (hydroxyprogesterone caproate injection) Subcutaneous Auto-Injector to Reduce the Risk of Preterm Birth in Certain At-Risk Women

February 15, 2018

WALTHAM, Mass., Feb. 14, 2018 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) approved the Makena® subcutaneous auto-injector drug-device combination product as a ready-to-administer treatment to reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered one preterm baby in […]

GSK receives European approval for expanded indication for Fluarix Tetra (Influenza Vaccine) for ages six months and older

February 15, 2018

GSK [LSE/NYSE: GSK] today announced the expanded indication for Fluarix Tetra (Quadrivalent Influenza Vaccine) has been approved in Europe to include adults and now children from six months of age for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine. […]

Sandoz announces US FDA approval and launch of Glatopa® 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis

February 14, 2018

Holzkirchen, February 13, 2018 – 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 acetate injection) 40 mg/mL three times-a-week therapy for relapsing forms of multiple sclerosis (MS). […]

Abiomed Receives Approval for Expanded FDA Indication for High Risk Percutaneous Coronary Intervention (PCI) Procedures

February 14, 2018

DANVERS, Mass., Feb. 14, 2018 (GLOBE NEWSWIRE) — Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support and recovery technologies, today announced that it has received an expanded U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for the Impella 2.5® and Impella CP® heart pumps during elective and urgent high risk percutaneous coronary […]

Celltrion Receives EU Approval for Trastuzumab Biosimilar

February 14, 2018

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion, Inc. (KRX:068270) announced today that the European Commission (EC) approved Herzuma® (trastuzumab biosimilar) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. The decision follows a positive opinion from the Committee for Medicinal Products […]

Ferring’s CLENPIQ™ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution for Colonoscopy Prep Now Available

February 13, 2018

PARSIPPANY, N.J., Feb. 12, 2018 /PRNewswire/ — Ferring Pharmaceuticals Inc. announced today that CLENPIQ™ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution for cleansing of the colon in adults undergoing a colonoscopy is now available by prescription in the United States. Approved by the U.S. Food and Drug Administration (FDA) in November 2017, […]

Icon Bioscience Receives FDA Approval for DEXYCU™, a Potentially Transformational Drug Therapy for Treating Inflammation Associated with Cataract Surgery

February 13, 2018

NEWARK, Calif.–(BUSINESS WIRE)–Icon Bioscience, Inc. (IBI), a specialty biopharmaceutical company focused on utilizing its Verisome® drug-delivery platform to develop unique intraocular eye-care therapeutics, today announced that the United States Food and Drug Administration (FDA) has approved IBI’s New Drug Application (NDA) for DEXYCU™ (dexamethasone intraocular suspension), a dropless, long-acting therapeutic for treating inflammation associated with […]

FDA Approves SYMDEKOTM (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older with Certain Mutations in the CFTR Gene

February 13, 2018

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved SYMDEKO™ (tezacaftor/ivacaftor and ivacaftor) for treating the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or who […]

Sandoz announces US FDA approval and launch of Glatopa® 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis

February 13, 2018

Holzkirchen, February 13, 2018 – 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 acetate injection) 40 mg/mL three times-a-week therapy for relapsing forms of multiple sclerosis (MS). […]

Abiomed Receives Approval for Expanded FDA Indication for Cardiomyopathy with Cardiogenic Shock

February 13, 2018

DANVERS, Mass., Feb. 13, 2018 (GLOBE NEWSWIRE) — Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, announced today that it has received an expanded U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its Impella 2.5®, Impella CP®, Impella 5.0® and Impella LD® heart pumps to provide treatment for […]

Novo Nordisk Launches Rebinyn® in the United States for People with Hemophilia B

February 9, 2018

PLAINSBORO, N.J., February 8, 2018 – Novo Nordisk, a global healthcare company, today announced that Rebinyn®, Coagulation Factor IX (Recombinant), GlycoPEGylated, is now available in the United States for the treatment of hemophilia B. Rebinyn® is an extended half-life injectable medicine used to treat and control bleeding in adults and children with hemophilia B. It […]

Novartis receives FDA approval for Cosentyx® label update to include moderate-to-severe scalp psoriasis

February 8, 2018

Basel, February 8, 2018 – 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 scalp psoriasis – one of the difficult-to-treat forms of the disease, which […]

First targeted treatment for adults with moderate-to-severe atopic dermatitis, Dupixent™, now available in Canada

February 8, 2018

TORONTO, Feb. 8, 2018 /CNW/ – Dupixent™ (dupilumab) is now available in Canada for adult patients living with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.1   AD, a form of eczema, is a chronic inflammatory disease with symptoms often appearing as […]

Norgine’s PLENVU® (NER1006) Receives Approval in Germany for Bowel Cleansing in Adults Prior to any Procedure Requiring a Clean Bowel

February 8, 2018

AMSTERDAM, February 8, 2018 /PRNewswire/ —   PLENVU® is the first 1-litre PEG bowel preparation PLENVU® is superior to MOVIPREP® in providing high-quality cleansing in the colon ascendens – an important area for adenoma detection Norgine B.V. today announced that the marketing authorisation for PLENVU® for bowel cleansing in adults prior to any procedure requiring […]

U.S. FDA approves Gilead triple HIV drug, rival files lawsuit

February 8, 2018

(Reuters) – The U.S. Food and Drug Administration on Wednesday approved Biktarvy, Gilead Sciences Inc’s once-daily, triple-combination tablet for treatment of HIV infection, paving the way for the biotech company to capture more of the multibillion-dollar HIV drug market.   Biktarvy combines new integrase inhibitor bictegravir with Descovy, an older medication that combines nucleoside reverse […]

AMAG Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application (sNDA) for Feraheme® (ferumoxytol injection)

February 5, 2018

WALTHAM, Mass., Feb. 05, 2018 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has approved its application to broaden the existing label for Feraheme® (ferumoxytol injection) beyond the current chronic kidney disease (CKD) indication to include all eligible adult Iron Deficiency Anemia (IDA) patients who have […]

FDA Clears Oricula Therapeutics Investigational New Drug Application for Clinical Trials

February 5, 2018

SEATTLE, Feb. 5, 2018 /PRNewswire/ — ORICULA THERAPEUTICS, LLC., a biotech company introducing medications to preserve hearing and balance, announced FDA permission to begin volunteer human testing for safety, tolerability, and pharmacokinetics of their novel, new medicine, ORC-13661. In animal studies, ORC-13661 provided highly significant protection of hearing in rats exposed to high doses of […]

FDA Approves AVYCAZ® (ceftazidime and avibactam) for the Treatment of Patients with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

February 2, 2018

DUBLIN, Feb. 1, 2018 /PRNewswire/ — Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Allergan’s supplemental New Drug Application (sNDA) to expand the approved use of AVYCAZ® (ceftazidime and avibactam) to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia […]

Tagrisso® (osimertinib) receives full Health Canada approval for targeted treatment of non-small cell lung cancer

February 1, 2018

MISSISSAUGA, ON, Jan. 31, 2018 /CNW/ – AstraZeneca Canada announces that Health Canada has granted full approval (Notice of Compliance) for Tagrisso® (osimertinib) for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) whose disease has progressed on or after EGFR tyrosine kinase […]

Ferring’s ZOMACTON® (somatropin) for Injection Receives FDA Approval to Treat Growth Hormone Deficiency in Adults

February 1, 2018

PARSIPPANY, N.J., Jan. 31, 2018 /PRNewswire/ — Ferring Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ZOMACTON® (somatropin) for Injection 5 mg and 10 mg recombinant human growth hormone (GH) indicated for replacement of GH in adults with GH deficiency.   Adult growth hormone deficiency (GHD) occurs in approximately […]

Advanced Accelerator Applications Receives FDA Approval for Lutathera® for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

January 26, 2018

Basel, January 26, 2018 – 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*) for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, […]

FDA approves new treatment for certain digestive tract cancers

January 26, 2018

SILVER SPRING, Md., Jan. 26, 2018 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for […]

Alnylam Announces EMA Acceptance of Marketing Authorisation Application (MAA) for Patisiran for the Treatment of Hereditary ATTR (hATTR) Amyloidosis

January 26, 2018

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) and initiated its review for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of hereditary ATTR (hATTR) amyloidosis. The filing of the MAA was previously […]

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