New Jersey-based specialty generic pharmaceutical manufacturing firm Teligent recently obtained U.S. Food and Drug Administration approval — its third in 2017 — for its Abbreviated New Drug Application (ANDA) regarding its Erythromycin Topical Gel USP, 2%. Read More »
Los Angeles-based Puma Biotechnology Inc.’s FDA-approved Nerlynx (neratinib) tablets — a kinase inhibitor developed to treat breast cancer — will be circulated by Cary, North Carolina’s Biologics Inc. as per a limited distribution agreement between the companies. Read More »
In answer to New Jersey-based Eagle Pharmaceuticals Inc.’s New Drug Application (NDA) for Ryanodex (dantrolene sodium) to treat exertional heat stroke (EHS), the U.S. Food and Drug Administration (FDA) recently issued a Complete Response Letter. Read More »
The U.S. Food and Drug Administration is creating new regulation on tobacco and nicotine to reduce diseases and death brought on by tobacco use. Read More »
Phoenix-based Insys Therapeutics Inc. recently revealed that its new branded liquid formulation Syndros (dronabinol oral solution) is on the market to address side effects of AIDS and chemotherapy such as weight loss and related symptoms. Read More »
LabCorp, a provider of diagnostic solutions and breakthrough medicines, recently announced plans for its all-cash acquisition of international contract research firm Chiltern of England for approximately $1.2 billion, enhancing LabCorp’s portfolio and capabilities. Read More »
Innovus Pharmaceuticals Inc., an expanding commercial-stage medication company that provides over-the-counter products for both men and women, will be filing a product licence application in Canada for its drug, Xyralid. Read More »
Filling a need for those youngsters who fear needles or find pills unmanageable, Denver-based Silvergate Pharmaceuticals Inc. recently released Xatmep, the first methotrexate oral solution to gain approval from the U.S. Food and Drug Administration. Read More »
Formulated to detect the presence of the potent opioid fentany in urine, California-based Immunalysis Corp.’s branded immunoassay Sefria — the first of its kind — recently achieved 510(k) clearance from the U.S. Food and Drug Administration. Read More »
Boston-based biopharmaceutical firm Parexel International Corp. has had two of its leaders earn a place on PharmaVOICE magazine’s annual list of the life science industry’s top 100 “inspiring people” for their overall industry contribution and highest level of commitment. Read More »
Spectrum Pharmacy Products, a top manufacturer and distributor of pharmaceutical chemicals and supplies, is partnering with the Independent Pharmacy Alliance (IPA), a retail pharmacy and trade group that represents thousands of pharmacies in the Northeastern U.S., PR Newswire reported. Read More »
To better assess patients’ oral and pharyngeal functioning for the purpose of easing swallowing disorders, the U.S. Food and Drug Administration recently approved Bracco Diagnostics Inc.’s Varibar Nectar (barium sulfate) Oral Suspension. Read More »
Animal health specialist firm Zoetis of Parsippany, New Jersey recently completed an approximately $85 million acquisition of Irish biologic therapeutics business Nexvet Biopharma PLC, with the deal expected to boost the company’s market share. Read More »
Cumberland Pharmaceuticals, specializing in therapies for underserved populations, has begun shipping its Totect brand of dexrazoxane, for alleviating certain side effects of chemotherapy during cancer treatment, to U.S. wholesalers. Read More »
Following successful clinical results, Vertex Pharmaceuticals Inc. recently gained approval from the U.S. Food and Drug Administration (FDA) to treat more than 600 cystic fibrosis (CF) patients with its proprietary Kalydeco (ivacaftor) product. Read More »
Spectrum Pharmaceuticals Inc., a biotechnology company focusing on hematology and oncology, recently completed enrollment for its Rolontis Phase 3 Advance pivotal study. Read More »
Celgene Corp. and Agios Pharmaceuticals Inc. recently received U.S. Food and Drug Administration approval for IDHIFA as a treatment for adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with an isocitrate dehydrogenase-2 (IDH2) mutation. Read More »
Neovacs, a company focusing on immunotherapies that treat autoimmune diseases, recently announced its Investigation New Drug application for IFNalpha Kinoid was cleared by the U.S. Food and Drug Administration. Read More »
Pharmacy Times, the leading media resource for pharmacists and the pharmacy industry, ranked highest in ad visibility and highest in readership in the 2017 Kantar Media Pharmacy Readership study. Read More »
Amgen and Allergan submitted a Biologics License Application for ABP 980, a biosimilar candidate to Herceptin, to the U.S. Food and Drug Administration. Read More »
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