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Xyzal Allergy approved for over-the-counter sales

American Pharmacy News Reports | Feb 3, 2017
Xyzal offers 24-hour relief from the symptoms that come with hay fever.

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

American Pharmacy News Reports | Feb 1, 2017
The guidance helps to codify names for new drugs set to be released or under development.

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

Aaron Crider | Feb 1, 2017
A new Alzheimer’s treatment has received a fast-track designation from the FDA.

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

American Pharmacy News Reports | Feb 1, 2017
d-Methadone is designed to help patients suffering with treatment-resistant depression.

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

American Pharmacy News Reports | Jan 31, 2017
Linzess is a treatment for people suffering with chronic idiopathic constipation.

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

American Pharmacy News Reports | Jan 31, 2017
The new nasal delivery system allows Narcan to go directly into the lungs and nervous system.

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

American Pharmacy News Reports | Jan 29, 2017
The new formulary is designed to help expedite availability of effective treatment options to patients with cancer.

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

American Pharmacy News Reports | Jan 28, 2017
Policy makers have often expressed a need to be proactive in receiving patient information ahead of FDA approvals.

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

American Pharmacy News Reports | Jan 26, 2017
Studies have shown that baricitinib reduces inflammation.

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

American Pharmacy News Reports | Jan 24, 2017
The U.S. Food and Drug Administration has approved Vantrelatm.

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

American Pharmacy News Reports | Jan 21, 2017
Vermildy has shown to be as effect as Gliead’s Viread but with a much smaller dose.

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

American Pharmacy News Reports | Jan 21, 2017
Trastuzumab is one of six products co-developed by the two companies.

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

American Pharmacy News Reports | Jan 21, 2017
Ovarian cancer causes more deaths in the U.S. than any other gynecologic cancer.

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

American Pharmacy News Reports | Jan 21, 2017
Tecentriq has been made available to some people with 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

American Pharmacy News Reports | Jan 21, 2017
With mCNV, abnormal blood vessels grow directly into the retina.

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

American Pharmacy News Reports | Jan 18, 2017
PNH leads to hemolysis, in which a person’s red blood cells are destroyed.

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

American Pharmacy News Reports | Jan 14, 2017
“We are very pleased to receive FDA’s orphan drug designation for emixustat,” Acucela's Dr. Ryo Kubota said.

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

American Pharmacy News Reports | Jan 10, 2017
Patients who took part in the study began to see improvement in their pain levels within 15 to 30 minutes.

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

LocalLabs News Service | Jan 10, 2017

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.

American Pharmacy News Reports | Jan 8, 2017
HCI is the generic form of CellCept.

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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