Xyzal Allergy approved for over-the-counter sales
Sanofi has received FDA approval of Xyzal Allergy 24HR, an over-the-counter option for those suffering with certain allergies. Read More »
FDA issues new naming guidance for biologics, biosimilars
The U.S. Food and Drug Administration released its final guidance on naming biologics and biosimilars. Read More »
FDA gives new Alzheimer's treatment fast-track designation
ABBV-8E 12 -- a new Alzheimer’s treatment still in development -- received a fast-track designation from the U.S. Food and Drug Administration to be moved to clinical trials. Read More »
FDA approves d-Methadone for clinical trials
Relmada Therapeutics, a biopharmaceutical company that specializes in developing treatments for central nervous system diseases, received approval from the U.S. Food and Drug Administration to advance a new therapy to clinical trials. Read More »
Linzess for constipation receives FDA approval
The U.S. Food and Drug Administration has approved Linzess, a treatment for people suffering with chronic idiopathic constipation. Read More »
Narcan nasal application receives FDA approval
The U.S. Food and Drug Administration has given approval for the use of Narcan, an emergency treatment medication to counteract heroin overdoses, in a nasal spray form. Read More »
New drug formulary creates greater access to cancer treatments
A new drug formulary that will allow cancer centers to access approved and investigational drugs for the use of preclinical and clinical studies in cancer treatment has been launched by the National Cancer Institute. Read More »
Academy recommends patient information be shared with pharmaceutical companies
New consensus recommendations from the Academy of Managed Care Pharmacy ask the U.S. Food and Drug Administration to allow biopharmaceutical companies to share patient health and economic information with policy makers. Read More »
Eli Lilly granted extended review period for arthritis drug
The FDA has extended the review period for Baricitnib, a new once-a-day drug for rheumatoid arthritis. Read More »
FDA approves Teva pain medication for long-term use
The U.S. Food and Drug Administration has approved Vantrelatm, a pain medication designed by Teva Pharmaceutical Ltd., for long-term use in time-released capsules. Read More »
European Commission OK's Gilead drug for Hepatitis C
The European Commission has granted Gilead Sciences Inc. marketing authorization for Vemlidy, a drug used in the treatment of people suffering from chronic Hepatitis B infections. Read More »
FDA approves application for new breast cancer treatment
The U.S. Food and Drug Administration recently approved a license application for Mylan Biotechnology, in collaboration with Biocon, for the use of biosimilar tratuzumab in the treatment of breast cancer. Read More »
Ovarian cancer treatment receives FDA approval
Ovarian cancer patients who have a sensitivity to chemotherapy will soon have another option to treat their disease as the U.S. Food and Drug Administration has approved Avastin as an alternative to or supplement for chemotherapy. Read More »
FDA approves review of Genentech drug to treat advanced bladder cancer
Biotech group Genentech scored a big victory as the U.S. Food and Drug Administration has granted a priority review of the company’s newest cancer-treating drug, Tecentriq. Read More »
Treatment for extrerme nearsightedness receives FDA approval
The U.S. Food and Drug Administration has approved the use of Lucentis, created by biotech company Genentech, for people suffering with severe nearsightedness. Read More »
Alexion receives orphan drug designation for PNH treatment
The U.S. Food and Drug Administration granted orphan drug designation to Alexion Pharmaceuticals for ALXN1210, a drug for treating patients with paroxysmal nocturnal hemoglobinuria. Read More »
Acucela treatment receives FDA orphan drug designation
The U.S. Food and Drug Administration granted orphan drug designation to Acucela's leading drug candidate emixustat hydrochloride, which was created to treat Stargardt disease. Read More »
AcelRX submits FDA application for pain-reducing drug
AcelRX Pharmaceuticals recently submitted a new drug application to the U.S. Food and Drug Administration for ARX-04. Read More »
GUEST COMMENTARY: PBMs: Protecting Consumers and Employers From High Drug Prices
Marrk Merritt, president and CEO of the Pharmaceutical Care Management Association, writes, "The truth is PBMs reduce costs for payers and consumers by 30 percent or more and are part of the solution. It’s time for drug manufacturers to take responsibility for their own business mistakes instead of blaming others." Read More »
Endo International releases HCI generic injection drug in U.S.
Endo International, PLC, a subsidiary of Par Pharmaceutical, recently released mycophenolate mofetil hydrochloride (HCI) in the U.S. following Food and Drug Administration approval of its Abbreviated New Drug Application. Read More »
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