Approvals

Novartis drug Tasigna® (nilotinib) secures EU approval for first and second-line treatment of Ph+ CML-CP in children

November 20, 2017

Basel, November 20, 2017 – Novartis announced today that the European Commission (EC) approved Tasigna® (nilotinib) for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) and pediatric patients with Ph+ CML-CP with resistance or intolerance to prior therapy including imatinib. Tasigna is the only […]

TESARO Announces European Commission Approval of ZEJULA® for Women With Recurrent Ovarian Cancer

November 20, 2017

ZUG, Switzerland, Nov. 20, 2017 (GLOBE NEWSWIRE) — TESARO, Inc. (NASDAQ:TSRO), an oncology focused biopharmaceutical company, announced today that the European Commission (EC) has granted marketing authorization for ZEJULA® (niraparib) as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who […]

U.S. FDA Approves Kaléo’s AUVI-Q® (Epinephrine Injection, USP) 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children

November 20, 2017

Richmond, VA (November 20, 2017) kaléo, a privately-held pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for AUVI-Q®(epinephrine injection, USP) 0.1 mg, the first and only epinephrine auto-injector (EAI) specifically designed for the treatment of life-threatening allergic reactions, including anaphylaxis, in infants and […]

FASLODEX® (fulvestrant) Receives US FDA Approval for the Treatment of Advanced Breast Cancer in Combination with Abemaciclib

November 15, 2017

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved a new indication for FASLODEX® (fulvestrant), expanding the indication to include use with abemaciclib, a CDK4/6 inhibitor, for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) in women […]

Fasenra (Benralizumab) Receives US FDA Approval For Severe Eosinophilic Asthma

November 15, 2017

WILMINGTON, Del., November 14, 2017) – AstraZeneca (NYSE:AZN) and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has approved FASENRA™ (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. FASENRA is not approved […]

Merck Receives FDA Approval of PREVYMIS™ (letermovir) for Prevention of Cytomegalovirus (CMV) Infection and Disease in Adult Allogeneic Stem Cell Transplant Patients

November 9, 2017

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved PREVYMIS™ (letermovir) once-daily tablets for oral use and injection for intravenous infusion. PREVYMIS is indicated for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in adult […]

U.S. FDA Approves Auryxia® (ferric citrate) Tablets as a Treatment for People with Iron Deficiency Anemia and Chronic Kidney Disease, Not on Dialysis

November 7, 2017

BOSTON, Nov. 07, 2017 (GLOBE NEWSWIRE) — Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a company focused on bringing innovative medicines to people with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has approved Auryxia for an additional indication. The approval is for the treatment of iron deficiency anemia in adults with chronic kidney […]

Indivior drug to fight opioid addiction recommended by U.S. panel

November 2, 2017

(Reuters) – Indivior’s experimental drug to help fight America’s growing opioid addiction crisis has been recommended for approval by a U.S. advisory panel, boosting its sales prospects as competitors threaten revenues from an older product.   Shares in the London-listed company, which specializes in addiction treatment, were 11 % higher by 0855 GMT on Wednesday […]

AstraZeneca Diabetes Drug Formulation Gets FDA Nod

October 26, 2017

AstraZeneca PLC (AZN.LN) has received approval from the U.S. Food and Drug Administration for a new formulation of its type-2 diabetes treatment option Bydureon, it said Monday.   The pharmaceutical company said that the regulator has given the green light to its Bydureon BCise injectable suspension drug–a single-dose autoinjector device that is used once a […]

Idifarma Approved For EU-GMP Commercial Capsule Manufacturing

October 26, 2017

A Spanish contract development and manufacturing organisation (CDMO) has expanded its GMP manufacturing offering with the installation of new automatic capsule filling capabilities at its EU-GMP approved plant in Pamplona, Spain. The new Bosch GKF-702 automatic capsule filling machine, which is capable of manufacturing from 3,000 to 42,000 hard capsules per hour, is now fully […]

Nexus Pharmaceuticals Receives FDA Approval for Procainamide HCL Injection, USP

October 20, 2017

VERNON HILLS, Ill., Oct. 19, 2017 /PRNewswire/ — Nexus Pharmaceuticals announced today the immediate availability in the United States of Procainamide HCL Injection, USP. Nexus Pharmaceuticals’ Procainamide HCL Injection, USP is available as a multi dose vial containing 1,000 mg per 2 mL (500 mg/mL) or as a multi dose vial containing 1,000 mg per […]

Kite’s Yescart (Axicabtagene Ciloleucel) Becomes First CAR T Therapy Approved by the FDA for the Treatment of Adult Patients With Relapsed or Refractory Large B-Cell Lymphoma After Two or More Lines of Systemic Therapy

October 19, 2017

FOSTER CITY, Calif. & SANTA MONICA, Calif.–(BUSINESS WIRE)–Kite, a Gilead Company, (Nasdaq: GILD) today 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 lymphoma after […]

Janssen Announces U.S. FDA Approval Of STELARA® (ustekinumab) For The Treatment Of Adolescents With Moderate To Severe Plaque Psoriasis

October 18, 2017

HORSHAM, Pa., Oct. 13, 2017 /PRNewswire/ — Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for STELARA® (ustekinumab) for the treatment of adolescents (12 years of age or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Today’s approval […]

Anika Announces Regulatory Approval for MONOVISC® in Australia for the Treatment of Pain Associated with Osteoarthritis of all Synovial Joints

October 17, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced that regulatory authorities in Australia granted approval to MONOVISC®, Anika’s single injection viscosupplement for the treatment of pain associated with osteoarthritis of all synovial joints, including the hip and […]

GSK announces first approval of Shingrix in Canada

October 16, 2017

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that Shingrix has been approved in Canada for the prevention of shingles (herpes zoster) in people aged 50 years or older.[i] Shingrix is a non-live, recombinant subunit adjuvanted vaccine given intramuscularly in two doses. Shingles is caused by reactivation of the varicella zoster virus, the same virus that causes […]

Janssen Announces U.S. FDA Approval Of STELARA® (ustekinumab) For The Treatment Of Adolescents With Moderate To Severe Plaque Psoriasis

October 16, 2017

HORSHAM, Pa., Oct. 13, 2017 /PRNewswire/ — Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for STELARA® (ustekinumab) for the treatment of adolescents (12 years of age or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Today’s approval […]

Janssen Announces U.S. FDA Approval Of STELARA® (ustekinumab) For The Treatment Of Adolescents With Moderate To Severe Plaque Psoriasis

October 16, 2017

HORSHAM, Pa., Oct. 13, 2017 /PRNewswire/ — Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for STELARA® (ustekinumab) for the treatment of adolescents (12 years of age or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Today’s approval […]

Galderma Announces FDA Approval of Restylane® Silk as the First HA Dermal Filler Approved for Injection via Cannula

October 13, 2017

FORT WORTH, Texas, Oct. 12, 2017 /PRNewswire/ — Galderma, a global leader focused on medical solutions in skin health, announced today it has received U.S. Food and Drug Administration (FDA) approval for the use of a small blunt tip cannula with Restylane® Silk for lip augmentation.2 Restylane® Silk was the first FDA-approved hyaluronic acid (HA) […]

FDA Advisory Committee Unanimously Recommends Approval of Investigational LUXTURNA™ (voretigene neparvovec) for Patients with Biallelic RPE65-mediated Inherited Retinal Disease

October 13, 2017

PHILADELPHIA, Oct. 12, 2017 — Spark Therapeutics (NASDAQ: ONCE), a fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, announced today that the U.S. Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Advisory Committee has unanimously recommended (16-0) approval of LUXTURNA™ (voretigene neparvovec), an investigational, potential one-time gene therapy, […]

U.S. FDA Approves LYRICA® CR (pregabalin) Extended-Release Tablets CV New formulation may offer convenience to patients

October 12, 2017

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today that the United States Food and Drug Administration (FDA) has approved LYRICA® CR (pregabalin) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and the management of postherpetic neuralgia (PHN). LYRICA CR did not receive approval for the […]

Flexion Therapeutics Announces FDA Approval of Zilretta™ (triamcinolone acetonide extended-release injectable suspension) for Osteoarthritis (OA) Knee Pain

October 9, 2017

BURLINGTON, Mass., Oct. 06, 2017 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the U.S. Food and Drug Administration (FDA) approved Zilretta™ (triamcinolone acetonide extended-release injectable suspension), the first and only extended-release, intra-articular injection for osteoarthritis knee pain. Zilretta is a non-opioid medicine that employs Flexion’s proprietary microsphere technology to provide proven pain […]

Flexion Therapeutics Announces FDA Approval of Zilretta™ (triamcinolone acetonide extended-release injectable suspension) for Osteoarthritis (OA) Knee Pain

October 9, 2017

Innovative, non-opioid, intra-articular therapy, proven to deliver meaningful analgesia over 12 weeks in patients with moderate to severe OA knee pain Product label also includes positive data from type 2 diabetes study Commercial supply expected to be available by late October following recent completion of manufacturing process validation Conference call scheduled for Monday, October 9, […]

FDA approves implantable device to treat moderate to severe central sleep apnea

October 9, 2017

The U.S. Food and Drug Administration today 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 the chest that is responsible for sending signals to the diaphragm to stimulate breathing. “This implantable device […]

Mylan, in Partnership with Synthon, Receives Marketing Authorization Approval in Europe for First Generic for Copaxone® 40 mg/mL

October 6, 2017

HERTFORDSHIRE, England and PITTSBURGH, Oct. 5, 2017 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) today announced that partner, Synthon, received marketing authorization approval in Europe for Glatiramer Acetate Injection 40 mg/mL, a therapeutically equivalent generic version of Teva’s Copaxone® 40 mg/mL, indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a […]

Alcon receives CE Mark for first-of-its-kind AutonoMe(TM) preloaded intraocular lens (IOL) delivery system with Clareon® IOL

October 6, 2017

Basel, October 6, 2017 – Alcon, the global leader in eye care and a division of Novartis, has achieved European CE Mark for the Clareon® IOL with the AutonoMe(TM) delivery system. AutonoMe(TM) is the first-and-only automated, disposable, pre-loaded IOL delivery system that enables precise delivery of the IOL into the capsular bag in patients undergoing […]

Mylan surges, Teva slumps after FDA approves Copaxone copy

October 5, 2017

(Reuters) – Mylan NV’s long-awaited U.S. approval for its generic version of rival Teva’s blockbuster multiple sclerosis treatment Copaxone drove Mylan’s shares up around 18 percent on Wednesday while Teva shares plunged.   The approval late on Tuesday by the U.S. Food and Drug Administration came earlier than both companies had expected. It was issued […]

Alvogen Obtains First Approval for Glatiramer Acetate 40 mg/mL in Europe

October 5, 2017

PINE BROOK, N.J.–(BUSINESS WIRE)–Alvogen today announced the successful closure of the decentralized procedure for RemurelTM (glatiramer acetate) 40 mg/mL, the first generic equivalent of CopaxoneTM 40 mg/mL in Europe.   Alvogen is already successfully marketing a once daily subcutaneous 20 mg/mL prefilled syringe under the brand name RemurelTM. The approval of the generic three times […]

Regulatory Approval in Europe Granted for Synthon’s Glatiramer Acetate 40 mg/ml

October 5, 2017

Nijmegen, the Netherlands, October 05, 2017 / B3C newswire / — Synthon today announced that it has successfully concluded the decentralized procedures for glatiramer acetate 40 mg/ml pre-filled syringe for the treatment of relapsing forms of multiple sclerosis and received regulatory approval in Europe. Synthon’s three-times-a-week glatiramer acetate is a therapeutically equivalent version of the […]

Vical Announces that its Antifungal VL-2397 is Eligible for Limited Use Indication Approval by FDA Based on a Single Phase 2 Efficacy Trial

October 3, 2017

SAN DIEGO, Oct. 02, 2017 (GLOBE NEWSWIRE) — Vical Incorporated (Nasdaq:VICL) today announced that the U.S. Food and Drug Administration (FDA) has advised that Vical’s investigational antifungal VL‑2397 would be eligible for a Limited Use Indication (LUI) approval assuming a successful outcome of a single Phase 2 trial carried out in accordance with a protocol […]

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