New Approvals – Page 14

Abeona Therapeutics Receives FDA Rare Pediatric Disease Designation for ABO-202 Gene Therapy Program in CLN1 Disease

Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, announced today that the FDA has granted Rare Pediatric Disease Designation for the ABO-202 program (AAV-CLN1), an AAV-based gene therapy for the treatment of CLN1 disease (infantile and late infantile onset Batten disease).

Source: Tmcnet
432
March 19, 2018

FDA Grants Breakthrough Device Designation to Polyganics’ Liver and Pancreas Sealant Patch

Polyganics, a privately held medical technology company that develops, manufactures and commercializes bioresorbable medical devices, announced that the US Food and Drug Administration (FDA) has granted Polyganics’ request for Breakthrough Device designation to its Liver and Pancreas Sealant Patch. The Liver and Pancreas Sealant patch is considered a unique breakthrough in the prevention of fluid leakage after hepato-pancreato-biliary (HPB) procedures, for which currently no approved or cleared alternatives exist.

Source: polyganics
656
March 15, 2018

bioresorbable medical devices FDA New Approvals Polyganics

Busy Sanofi takes a pass on one of Alnylam’s rare disease drugs, FDA offers ‘breakthrough’ status for PhIII

A couple of months after Sanofi $SNY and Alnylam $ALNY retooled their RNAi collaboration so that the French pharma giant could concentrate on their hemophilia therapy while giving up rights to the biotech’s patisiran, the two partners are also going their separate ways on a late-stage drug for rare cases of primary hyperoxaluria type 1.

Source: Endpts
566
March 14, 2018

hemophilia lumasiran New Approvals RNAi

The Menarini Group Announced Marketing Authorization Application for Delafloxacin

The Menarini Group announced today that on March 6th 2017 it submitted a Marketing Authorization Application for delafloxacin at the European Medicines Agency (EMA) under the trade name Quofenix. The proposed indication for delafloxacin in Europe is the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) and the conclusion of the European regulatory process is expected in IIQ 2019.

Source: finance.yahoo
476
March 13, 2018

ABSSSI delafloxacin New Approvals

FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world

The U.S. Food and Drug Administration expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, the agency approved the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world.

Source: FDA
639
March 9, 2018

FDA heart valves medical device New Approvals

FDA approves new HIV treatment for patients who have limited treatment options

Today, the U.S. Food and Drug Administration approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV). Trogarzo is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications.

Source: Prnewswire
484
March 8, 2018

antiretroviral HIV New Approvals

First European filing acceptance of a selective sodium glucose cotransporter-2 (SGLT-2) inhibitor in type-1 diabetes

AstraZeneca today announced that the European Medicines Agency has accepted the Marketing Authorisation Variation forForxiga (dapagliflozin), a selective SGLT-2 inhibitor, for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D).

Source: astrazeneca
670
March 7, 2018

AstraZeneca diabetes Forxiga insulin New Approvals

Sanofi files Dupixent for severe asthma

US regulators have accepted for review Sanofi/Regeneron’s biologic Dupixent as an add-on maintenance treatment in certain adults and adolescents with moderate-to-severe asthma.

Source: pharmatimes
970
March 6, 2018

asthma Dupixent New Approvals Sanofi

Cardiovascular Systems, Inc. and OrbusNeich Announce FDA Clearance of the First and Only 1.0mm Coronary Balloon in the U.S.

Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the OrbusNeich® 1.0mm Sapphire® II PRO coronary balloon.

Source: Enhancedonlinenews
497
March 5, 2018

artery disease New Approvals Sapphire

MeiraGTx Earns EMA PRIME Designation for Achromatopsia Gene Therapy Candidate

A new gene therapy to treat a debilitating eye disorder is one step closer to regulatory approval in Europe. Gene therapy company MeiraGTx said the European Medicines Agency granted Priority Medicines (PRIME) designation to its candidate A002 for treatment of achromatopsia.

Source: biospace
415
March 5, 2018

achromatopsia eye disorder New Approvals

Abeona Therapeutics Receives FDA Rare Pediatric Disease Designation for ABO-202 Gene Therapy Program in CLN1 Disease

FDA Grants Breakthrough Device Designation to Polyganics’ Liver and Pancreas Sealant Patch

Busy Sanofi takes a pass on one of Alnylam’s rare disease drugs, FDA offers ‘breakthrough’ status for PhIII

The Menarini Group Announced Marketing Authorization Application for Delafloxacin

FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world

FDA approves new HIV treatment for patients who have limited treatment options

First European filing acceptance of a selective sodium glucose cotransporter-2 (SGLT-2) inhibitor in type-1 diabetes

Sanofi files Dupixent for severe asthma

Cardiovascular Systems, Inc. and OrbusNeich Announce FDA Clearance of the First and Only 1.0mm Coronary Balloon in the U.S.

MeiraGTx Earns EMA PRIME Designation for Achromatopsia Gene Therapy Candidate

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