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FDA committees find OPANA ER's risks outweigh benefits

American Pharmacy News Reports | Mar 16, 2017
The FDA will take the committee’s votes into consideration as it determines whether or not to take regulatory action on the drug.

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

American Pharmacy News Reports | Mar 15, 2017
Servier is sponsoring a UCART19 study titled CALM Phase 1 that began in the U.K. in August 2016.

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

American Pharmacy News Reports | Mar 15, 2017
Sales of the tablets in both dosages in the U.S. drew approximately $853 million for the 12-month period ending on Jan. 31.

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

American Pharmacy News Reports | Mar 15, 2017
The OSLER-1 open-label extension study involved 1,324 patients.

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

American Pharmacy News Reports | Mar 15, 2017
Acorda is awaiting the results of a challenge to these patents.

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

American Pharmacy News Reports | Mar 15, 2017
The multinational study was randomized, double blind and placebo-controlled and featured parallel groups.

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

American Pharmacy News Reports | Mar 10, 2017
The study is to be completed prior to the submission of a Biologicals Licensing Application. 

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 »

FDA to review type 2 diabetes drugs from Merck and Pfizer

American Pharmacy News Reports | Mar 10, 2017
The NDAs are for medicines containing ertugliflozin, an investigational SGLT2 inhibitor.

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 »

FDA approves ALK's application for dust mite allergy tablet

American Pharmacy News Reports | Mar 8, 2017
The medication is specially suited to address house dust mite-induced rhinitis.

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 »

FDA approves Noctivia for adults who deal with nocturnal polyuria

American Pharmacy News Reports | Mar 7, 2017
Noctivia nasal spray has gained FDA approval for adults who deal with nocturnal polyuria.

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 »

FDA moves forward with Teva's application for tardive dyskinesia drug

American Pharmacy News Reports | Mar 5, 2017
SD-809 has already been approved for Breakthrough Therapy Designation by the FDA. 

The FDA has approved the New Drug Application from Teva Pharmaceutical Industries Ltd. and granted Priority Review for SD-809, a treatment for tardive dyskinesia.  Read More »

FDA reclassifies rapid-flu detection standards

American Pharmacy News Reports | Mar 4, 2017
The lapse in quality of care was a concern in regard to the ability to detect the flu in patients.

The U.S. Food and Drug Administration recently reclassified Class I devices, which are antigen-based rapid influenza antigen detection systems that are meant to detect the virus from clinical specimens, to Class II devices that are subject to special controls, according to PRNewswire.  Read More »

FDA grants Perrigo approval for cough relief medication

American Pharmacy News Reports | Mar 4, 2017
The medication is intended for symptomatic cough relief in adults and children 6 and older.

The U.S. Food and Drug Administration has granted Perrigo Co. final approval for hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) 5 mg/1.5mg per 5 mL. Read More »

FDA approves deflazacort for muscular dystrophy patients

American Pharmacy News Reports | Feb 25, 2017
Marathon plans to release the drug this year under the brand name Emflaza.

The U.S. Food and Drug Administration has approved deflazacort, a new treatment for Duchenne muscular dystrophy in patients 5 years and older. Read More »

Competition Act tabled by House committee

American Pharmacy News Reports | Feb 23, 2017
The act seeks to remove barriers regarding competition of generic drugs.

The Lower Drug Costs through Competition Act created by the House Energy and Commerce Committee was taken off the committee’s fast track on Feb. 3 Read More »

Amgen applies to broaden use of Blincyto

American Pharmacy News Reports | Feb 21, 2017
Blincyto was granted a priority review designation by the FDA.

Biotech company Amgen submitted an application to the U.S. Food and Drug Administration for Blincyto, a drug used in the treatment of lymphoblastic leukemia, to broaden its uses and treatments. Read More »

Eli Lilly gets European marketing rights for Olumiant

American Pharmacy News Reports | Feb 20, 2017
The European Commission’s approval of Olumiant is an exciting milestone for the rheumatoid arthritis community.

The European Commission has granted Eli Lilly & Co. marketing rights for Olumiant, a drug used to treat patients suffering with severe rheumatoid arthritis. Read More »

FDA approves Parsabiv for adults with kidney failure

American Pharmacy News Reports | Feb 15, 2017
The number of people suffering from HPT has nearly doubled in the last five years.

The U.S. Food and Drug Administration approved Amgen's Parsabiv for the treating of secondary hyperparathyroidism in adults with chronic kidney failure and is administered at dialysis locations throughout the country. Read More »

Appeals court lifts injunction on Praluent

American Pharmacy News Reports | Feb 15, 2017
Regeneron is challenging both the injunction ruling and the validity of the appeal process.

A U.S. appeals court suspended a permanent injunction on Praluent, a cholesterol management drug, allowing Regeneron Pharmaceuticals to once again manufacture, market, sell and ship the drug around the world. Read More »

Manufacturer says blood pressure machines meet CDC guidelines

American Pharmacy News Reports | Feb 14, 2017
Kiosk machines must have software that directly transfers results to the pharmacist.

PharmaSmart International, a specialist in blood pressure kiosks, announced that its machines meet new Centers for Disease Control guidelines. Read More »

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