Tag: New Drug

FDA Approved 48 New Medicines in 2019

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After a flurry of activity in December, when the FDA approved seven new molecular entities (NMEs), the total of novel drugs that were given the green light this year reached 48, a number that ranks th...

Novartis Could Launch New Age-Related Macular Degeneration Drug in Europe in 2020

Novartis could launch its new age-related macular degeneration drug in Europe early next year after getting a green light from the EMA’s main advisory committee. The Committee for Medicinal Products ...

EMA Recommended for Approval Five New Medicines

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EMA’s human medicines committee (CHMP) recommended five medicines for approval at its December 2019 meeting. The Committee recommended granting a marketing authorisation for Beovu (brolucizumab) fo...

Grifols Announced Launch of XEMBIFY® for PI Treatment

Grifols, a leading global producer of plasma-derived medicines, announced the launch of its latest immunoglobulin (IG) innovation, XEMBIFY® (immune globulin subcutaneous human-klhw), the company’s fir...

EMA Recommended Seven New Medicines for Approval

EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its November 2019 meeting. The Committee recommended granting a marketing authorisation for Isturisa* (osilodrosta...

Chugai Pharma launched Hemlibra® for Prophylaxis of Bleeding Episodes

Chugai Pharmaceutical Co., Ltd. announced that Chugai Pharma Taiwan Ltd., a wholly owned subsidiary of Chugai, launched Hemlibra®, a new drug created by Chugai for routine prophylaxis of bleeding epis...

FDA Statement on Impurities in Ranitidine Drugs

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Americans deserve to have confidence in the quality of drugs the U.S. Food and Drug Administration regulates – from the prescription medicines they take to the over-the-counter (OTC) products they use...

EMA Recommended Seven New Medicines for Approval

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EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its October 2019 meeting. The Committee recommended granting conditional marketing authorisation for Ervebo (Ebola...

NICE Approved Elmiron for Bladder Pain Syndrome Treatment

The National Institute for Health and Care Excellence (NICE) Appraisal Committee has published a draft final appraisal regarding Elmiron (pentosan polysulfate sodium) for bladder pain syndrome. The...

EMA’s CHMP Recommended for Approval Seven New Medicines

european medicines agency
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its September 2019 meeting. The Committee recommended granting a marketing authorisation for Xospata* (gilteritini...

Ipsen Registered New Anticancer Drug in Russia

Ipsen announced the registration of a new anticancer drug in Russia, cabosantinib. The drug is intended for the treatment of advanced renal cell carcinoma (RCC) in adult patients with intermediate or ...

ALK Confirmed Launch of Sublingual Allergy Immunotherapy Tablet

ALK has confirmed the first launch of its sublingual allergy immunotherapy (SLIT) tablet for the treatment of tree pollen allergy. The product, branded ITULAZAX®, was launched in Germany after ALK rec...

Large Number of Drug Manufacturers Fail to Complete FDA’s Accelerated Approval Program

A large number of drug manufacturers are failing to complete the FDA’s Accelerated Approval Program, meaning not all available drugs are fully approved, finds a study. New research has reveal...

EvaluatePharma: FDA to Approve 11 Blockbuster Candidates in August

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The U.S. Food and Drug Administration (FDA) will likely approve 11 innovative medicines in August, and the list includes a strong blockbuster candidate upadacitinib, an oral Janus kinase (JAK) inhibit...

FDA’s Arthritis Advisory Committee Recommended to Approve BI’s Ofev®

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Boehringer Ingelheim announced that the FDA’s Arthritis Advisory Committee recommended (10-7 vote) tor approve Ofev® (nintedanib) for the treatment of systemic sclerosis associated interstitial lung d...

Janssen Announced Positive Results from the Study for Ponesimod

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The Janssen Pharmaceutical Companies of Johnson & Johnson announced positive top-line results from the Phase 3 OPTIMUM study, which evaluated the efficacy and safety of ponesimod compared to Aubag...