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 recently announced that the European Commission (EC) granted the company authorization to bring to market Amgevita in all available indications. Read More »
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 recently announced positive data from the Phase 3 '482 study, which is the largest international multiple myeloma trial ever conducted. Read More »
Abbot recently announced that the U.S. Food and Drug Administration (FDA) approved its FlexAbility Ablation Catheter. Read More »
.jpg)
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 »
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 »
.jpg)
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 »
.jpg)
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 »
.jpg)
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 »
.jpg)
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 »
.jpg)
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 »
.jpg)
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 »
.jpg)
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 »
.jpg)
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 »
.jpg)
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 »
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 »
Merck, which is known as MSD outside the United States and Canada, and Pfizer Inc. recently announced the acceptance for review of three New Drug Applications by the U.S. Food and Drug Administration. Read More »
The Food and Drug Administration has approved ALK's Biologics License Application for a sublingual immunotherapy tablet aimed at combating the negative effects caused by dust mite allergies. Read More »
The U.S. Food and Drug Administration has approved Noctivia nasal spray for adults who deal with nocturnal polyuria, a condition that causes overproduction of urine during the night. Read More »
Alerts Sign-up
