Tag Archives: FDA

FDA Approves Roche’s TECENTRIQ as initial treatment for certain advanced bladder cancer patients

First and only cancer immunotherapy approved in advanced bladder cancer as initial treatment for those unable to receive cisplatin chemotherapy BASEL, 24-Apr-2017 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) … Read the full press release

Roche’s Marketing Authorisation Application and Biologics License Application for OCREVUS accepted by EMA and FDA

OCREVUS is the first investigational medicine seeking marketing authorisation for both relapsing and primary progressive multiple sclerosis (MS) FDA grants Priority Review Designation for OCREVUS Biologics License Application (BLA) BASEL, 29-Jun-2016 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced … Read the full press release

AstraZeneca announces that FDA accepted sNDA and granted Priority Review for BRILINTA® (ticagrelor) for patients with history of heart attack

LONDON, 4-5-2015 — /EuropaWire/ — AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) and granted Priority Review for BRILINTA® (ticagrelor) tablets for patients with a history of heart attack. … Read the full press release

Novartis: FDA grants priority review designation to investigational medicine for the treatment of heart failure

Decision could speed access to LCZ696 for HFrEF patients in the US, reducing total review time from 12 to 8 months Filing is based on results from the landmark PARADIGM-HF study[1] Nearly six million people live with heart failure in … Read the full press release

Roche received second Breakthrough Therapy Designation from FDA for its investigational cancer immunotherapy MPDL3280A (anti-PDL1)

Second FDA Breakthrough Therapy Designation for MPDL3280A following bladder cancer in 2014 BASEL, 3-2-2015 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received a second Breakthrough Therapy Designation from the United States Food and … Read the full press release

Symplmed Pharmaceuticals announced the FDA approval of Prestalia® for the treatment of hypertension licensed from Servier

Cincinnati, OH, 28-1-2015 — /EuropaWire/ — Symplmed Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) has approved Prestalia® (perindopril arginine and amlodipine) tablets for the treatment of hypertension licensed from Servier (Suresnes, France). Prestalia® is the first fixed-dose combination of … Read the full press release

Novartis: FDA granted accelerated approval of Bexsero® for active immunization to prevent invasive meningococcal disease caused by meningitis B

With today’s approval, Bexsero is now licensed in 37 countries; since first approval in Europe, over 1 million doses have been distributed worldwide Bexsero’s two-dose regimen offers a flexible dosing schedule, with the first and second doses administered at least … Read the full press release

Sanofi and subsidiary Genzyme announced that FDA approved LemtradaTM (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS)

Approval Establishes Genzyme’s MS Franchise in the U.S. with Two Approved Products; Follows Global Approvals PARIS, 17-11-2014 — /EuropaWire/ — Sanofi and its subsidiary Genzyme announced today that the U.S. Food and Drug Administration (FDA) has approved LemtradaTM (alemtuzumab) for … Read the full press release

Sanofi: Genzyme’s Cerdelga™ capsules the only first-line oral therapy for certain adult Gaucher disease type 1 approved by FDA

Only First-Line Oral Treatment for Adult Gaucher Disease Type 1 Paris, 22-8-2014 — /EuropaWire/ — Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has approved Cerdelga™ (eliglustat) capsules, the only … Read the full press release

Nanostart-holding MagForce AG and its subsidiary in US held FDA meeting regarding MagForce’s NanoTherm® Therapy Pre-Submission

Frankfurt / Berlin, Germany and Nevada, USA, 5-5-2014 — /EuropaWire/ — Nanostart-holding MagForce, a leading medical device company in the field of nanomedicine focused on oncology, together with its subsidiary MagForce USA, Inc. are pleased to report that an in-person meeting was … Read the full press release

Sanofi halts clinical trials and plans for regulatory filings with its investigational JAK2 inhibitor fedratinib

Paris, France, 21-11-2013 — /EuropaWire/ — Sanofi (EURONEXT: SAN and NYSE: SNY) announced today the decision to halt all clinical trials and cancel plans for regulatory filings with its investigational JAK2 inhibitor, fedratinib (SAR302503). Following a thorough risk-benefit analysis, including consultation with the U.S. … Read the full press release

U.S. FDA’s Nonprescription Drugs Advisory Committee recommends approval of Sanofi’s Nasacort AQ Nasal Spray for over-the-counter use in the U.S.

Treats Seasonal and Year-round Nasal Allergy Symptoms in Adults and Children  Paris, France, 06-8-2013 — /EuropaWire/ — Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration’s (FDA) Nonprescription Drugs Advisory Committee (NDAC) voted 10 to … Read the full press release

Novartis announced US Food and Drug Administration (FDA) granted Breakthrough Therapy designation to its serelaxin (RLX030) for acute heart failure

Recognition by the US Food and Drug Administration (FDA) that RLX030 has the potential to address a serious unmet medical need If approved, RLX030 has the potential to be the first treatment breakthrough for Acute Heart Failure patients in 20 … Read the full press release