FDA fast-tracks Shire's SHP655 for patients with ADAMTS13
Shire PLC's recombinant ADAMTS13 drug, SHP655, has been given fast-track designation by the U.S. Food and Drug Administration. Read More »
Allergan to sell FDA-approved Restasis in first multi-dose bottle
Restasis MultiDose will now be available and approved by the U.S. Food and Drug Administration for help treating patients with a type of Chronic Dry Eye by helping them make more of their own tears. Read More »
Allergan's Juvéderm Vollure XC approved for sale in the U.S.
The U.S. Food and Drug Administration has approved Allergan PLC’s Juvéderm Vollure XC for use correcting moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over 21. Read More »
FDA tentatively OKs Mylan's HIV/AIDS drug for developing nations
Mylan N.V., a global pharmaceutical company, recently announced the U.S. Food and Drug Administration (FDA) tentatively approved the company's New Drug Application for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg ("TLE400"). Read More »
Amgen receives European approval to market Amgevita
Amgen recently announced that the European Commission (EC) granted the company authorization to bring to market Amgevita in all available indications. Read More »
DEA rule would classify Syndros drug as controlled substance
An interim final rule introduced by the Drug Enforcement Agency would result in Insys Therapeutics Inc.'s Syndros product being placed in Schedule II of the Controlled Substances Act. Read More »
Amgen unveils positive data from Phase 3 '482 study
Amgen recently announced positive data from the Phase 3 '482 study, which is the largest international multiple myeloma trial ever conducted. Read More »
Abbot receives FDA approval for its FlexAbility ablation catheter
Abbot recently announced that the U.S. Food and Drug Administration (FDA) approved its FlexAbility Ablation Catheter. Read More »
Pfizer's combination antibiotic approved in U.K., Germany
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Pfizer Inc.'s combination antibiotic Zavicefta is now available in the United Kingdom and Germany for the treatment of Gram-negative bacterial infections requiring hospitalization. Read More »
FDA accepts application for Keryx Pharmaceutical's Auryxia
The U.S. Food and Drug Administration has accepted a supplemental New Drug Application for Auryxia tablets from Keryx Biopharmaceuticals Inc., a company specializing in innovative medicines to fight renal disease. Read More »
Pfizer China’s XELJANZ approved for rheumatoid arthritis treatment
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Chinese authorities recently approved Pfizer China’s oral Janus kinase inhibitor XELJANZ, with active ingredient tofacitinib citrate, indicated for treating adults with moderate to severely active rheumatoid arthritis. Read More »
Data shared from Phase 3 study on DUPIXENT treatment of atopic dermatitis
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Regeneron Pharmaceutical Inc. and Sanofi recently presented the results of their one-year Phase 3 CHRONOS study, showing that investigational drug DUPIXENT combined with topical corticosteroids achieved better results in treating uncontrolled moderate-to-severe atopic dermatitis than TCS alone. Read More »
Mylan launches Exemestane tablets in U.S. market following FDA approval
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The U.S. Food and Drug Administration recently issued its final approval for Mylan’s Abbreviated New Drug Application for its Exemestane Tablets in a 25mg dosage, which are a generic version of Pfizer’s Aromasin tablets. Read More »
FDA committees find OPANA ER's risks outweigh benefits
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Two U.S. Food and Drug Administration committees recently voted 18 to 8, with one abstention, that Endo International’s OPANA ER (oxymorphone hydrochloride extended release) no longer has a positive risk-to- benefits ratio. Read More »
FDA gives Servier's UCART19 therapy IND clearance
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The U.S. Food and Drug Administration recently issued Investigational New Drug clearance for Servier’s UCART19, allowing the company to proceed with clinical development of the allogeneic, gene-edited cellular therapy. Read More »
Mylan gains FDA approval for generic Pristiq in extended-release form
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Mylan N.V. recently launched its Desvenlafaxine extended-release tablets, a generic version of Pfizer’s Pristiq tablets, to treat major depressive disorder in the U.S. market in 50 and 100 mg doses. Read More »
JAMA Cardiology publishes findings from Amgen's 4-year study of Repatha
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The results from Amgen’s four-year follow up OSLER-1 study on Repatha, which is so far the longest PCSK9 inhibitor clinical trial, were recently published in JAMA Cardiology. Read More »
Acorda’s AMPYRA patents upheld by federal officials
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The U.S. Patent and Trademark Office Patent Trials and Appeal Board recently upheld four patents held by Acorda Therapeutics Inc. related to its AMPYRA (dalfampridine) Extended Release Tablets in 10 mg dosages. Read More »
FDA accepts Allergan filing for schizophrenia maintenance treatment drug
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The U.S. Food and Drug Administration has accepted Allergan PLC's filing of a supplemental New Drug Application based on new clinical data that would allow the company to list maintenance on its product label for VRAYLAR (cariprazine), a drug used to treat adults with schizophrenia. Read More »
Ampion closer to approval to treat severe osteoarthritis of the knee
The Office of Tissue Advancement Therapies, a branch of the Center for Biologics Evaluation and Research of the FDA, has progressed toward the acceptance of Ampio Pharmaceuticals' Ampion for a viable treatment option for severe osteoarthritis of the knee. Read More »
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