American Pharmacy News
  • People
  • Innovation
  • Regulatory
  • Industry
  • Federal Issues
  • State Issues
  • Directory
  • People
  • Innovation
  • Regulatory
  • Industry
  • Federal Issues
  • State Issues
  • Directory
  • Home
  • »
  • Stories
  • »
  • Regulatory

Lannett gets FDA approval for extended-release niacin tabs

American Pharmacy News Reports | Jun 23, 2017
The product is available in both 500-mg. and 1000-mg. tablet doses.

Philadelphia-based Lannett Company Inc. recently obtained approval from the U.S. Food and Drug Administration (FDA) for its generic formulation of niacin in extended-release form, with the product available in both 500-mg and 1000-mg tablet doses. Read More »

OncoSec's melanoma drug receives Orphan Drug Designation

American Pharmacy News Reports | Jun 23, 2017
Tavokinogene telsaplasmid is the active biologic agent in ImmunoPulse IL-12, OncoSec’s lead product candidate.

OncoSec Medical Inc.'s pIL-12 drug, also known as tavokinogene telsaplasmid, has been given an Orphan Drug Designation by the U.S. Food and Drug Administration. Read More »

FDA to review oncology drug from Amgen and Allergan

American Pharmacy News Reports | Jun 22, 2017
In the Phase 3 study analyzing the biosimilar’s performance in treating patients with non-squamous non-small cell lung cancer, the drug met its primary endpoint.

Amgen and Allergan's data supporting their Biologics License Application for ABP 215, a biosimilar candidate to Avastin (bevacizumab), will be reviewed by the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration by July 13. Read More »

Plaintiff lawyer ads may scare some Americans from taking their prescriptions, finds new survey

LocalLabs News Service | Jun 22, 2017

Do television ads by plaintiffs' lawyer firms hawking lawsuits over prescription drugs cause patients to cease taking their prescribed prescriptions? Read More »

FDA authorizes Aristada in diverse doses to combat schizophrenia

American Pharmacy News Reports | Jun 16, 2017
A common difficulty in medication administration is dosage adherence.

Alkermes PLC’s Aristada (aripiprazole lauroxil) injectable medication has won approval from the U.S. Food and Drug Administration as an extended-release injectable suspension to treat schizophrenia. Read More »

Sanofi Pasteur announces U.S. availability of Quadracel vaccine

American Pharmacy News Reports | Jun 16, 2017
The Centers for Disease Control recommends that children between the ages of 4 and 6 receive the vaccines that Quadracel provides.

Sanofi Pasteur's Quadracel vaccine has been approved by the U.S. Food and Drug Administration to protect children between the ages of 4 and 6 against diphtheria, tetanus, pertussis and poliomyelitis. Read More »

Enanta and AbbVie receive green light to study hepatitis C drug

American Pharmacy News Reports | Jun 16, 2017
The drug is the second protease inhibitor Enanta has collaborated on with AbbVie.

Enanta Pharmaceuticals Inc.'s New Drug Application (NDA) for its pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), developed in conjunction with AbbVie, has been accepted by the U.S Food and Drug Administration. Read More »

Spinraza gains European go-ahead to treat spinal muscular atrophy

American Pharmacy News Reports | Jun 13, 2017
Positive results from two major clinical studies contributed to endorsement of the product.

Spinraza (nusinersen) recently won European Commission authorization to treat 5q SMA — the most common form of spinal muscular atrophy — becoming the first such drug to achieve European approval, manufacturer Biogen announced from Cambridge, Massachusetts. Read More »

Pfizer meningitis drug gains European approval for young patients

American Pharmacy News Reports | Jun 13, 2017
Young people can be misled by meningococcal disease symptoms, which can resemble the flu.

Trumenba, Pfizer’s branded vaccine against certain forms of meningococcal disease, officially won approval from the European Commission for patients aged 10 years and up, representing progress for protection in the young adult demographic. Read More »

SCOTUS ruling in Sandoz v. Amgen will speed biosimilars to market, could save U.S. consumers billions

LocalLabs News Service | Jun 12, 2017

The U.S. Supreme Court issued a 9-0 ruling today that will have the effect of speeding the process for biosimilars going to market. Read More »

Otsuka, Proteus re-apply to FDA for digital drug approval

American Pharmacy News Reports | Jun 10, 2017
Otsuka and Proteus Digital Health requested FDA approval with an application for the invention.

A pioneering prototype blending a mood stabilizer with technology is on the radar for two companies determined to develop a combination drug/device that, if approved by the FDA, could potentially address serious mental health challenges. Read More »

Sanofi obtains FDA go-ahead for kidney transplant drug

Carol Ostrow | Jun 9, 2017
Thymoglobulin is intended for use in conjunction with standard immunosuppressive therapy following kidney transplants.

With kidney disease ranking in the nation’s top 10 causes of death, Sanofi recently announced a breakthrough with FDA approval of its branded Thymoglobulin for boosting immunosuppression for patients to prevent rejection following kidney transplants. Read More »

Pfizer plans Phase 3 study of Clostridium difficile vaccine

American Pharmacy News Reports | Jun 9, 2017
Clostridium difficile, a spore-forming pathogen, often targets people with altered gut microbial flora.

Pfizer Inc. recently shared positive data from its Phase 2 study examining Clostridium difficile (C. difficile) vaccine candidate, PF-06425090, a product created to help prevent C. difficile infection (CDI), which can include life-threatening diarrhea and pseudomembranous colitis. Read More »

Pfizer's Xeljanz receives positive opinion from European committee

American Pharmacy News Reports | Jun 9, 2017
More than 2.9 million people are currently living with moderate to severe rheumatoid arthritis in Europe.

Pfizer Inc. recently announced that its Xeljanz drug for treating moderate to severe active rheumatoid arthritis (RA) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Read More »

GSK submits Biologics License Application for influenza vaccine

American Pharmacy News Reports | Jun 5, 2017
Fluarix Quadrivalent was approved in 2012 in the United States to prevent influenza.

GSK has submitted a supplemental Biologics License Application for Fluarix Quadrivalent (influenza vaccine) to the U.S. Food a​​​​​nd Drug Administration. Read More »

Bavencio gains FDA approval for intravenous use

American Pharmacy News Reports | Jun 5, 2017
Bavencio was approved by the FDA for intravenous use.

Pfizer Inc. and EMD Serono, Merck KHaA’s biopharmaceutical arm in the United States and Canada, recently announced that Bavencio was approved by the Food and Drug Administration for intravenous use. Read More »

Diplomat Pharmacy offers new rheumatoid arthritis treatment

American Pharmacy News Reports | Jun 4, 2017
Approximately 1.5 million individuals in the U.S. suffer from rheumatoid arthritis.

Diplomat Pharmacy Inc. is now filling prescriptions for KEVZARA (sarilumab), an FDA-approved medication for the treatment of moderate-to-severe rheumatoid arthritis (RA) in patients who are intolerant to or not receiving enough of a response from other disease modifying antirheumatic drugs. Read More »

PCMA applauds FDA attempts to stop prescription drug price-fixing

American Pharmacy News Reports | Jun 4, 2017
Generic medications provide a lower cost alternative to consumers.

The Pharmaceutical Care Management Association (PCMA) released a statement in support of the Food and Drug Commissioner’s call to publish a list of off-patent drugs that may be vulnerable to price-fixing. Read More »

BioPharma Services passes trio of FDA inspections

American Pharmacy News Reports | Jun 4, 2017
The company has clinical facilities in Canada and the United States that can accommodate 250 patients.

BioPharma Services Inc. recently passed three Food and Drug Administration inspections without a single Form 483 being issued. Read More »

Merck's HIV drug receives preliminary European approval

American Pharmacy News Reports | Jun 2, 2017
Patients who weigh at least 88 pounds should take two of the tablets once a day.

Merck has received approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for ISENTRESS, a 600 mg. tablet coated in film and paired with other anti-retroviral prescriptions for those who have been diagnosed HIV-1. Read More »

  • «
  • 1
  • 2
  • ...
  • 8
  • 9
  • 10 (current)
  • 11
  • 12
  • ...
  • 16
  • 17
  • »
Trending

Shaun Noorian, CEO of Empower Pharmacy

CEO of Empower Pharmacy on GLP-1 access: 'The system treats compounding like a loophole instead of a lifeline'

Melissa Magstadt, Secretary of Health

South Dakota celebrates 25 years of Bright Start home visiting program

Melissa Magstadt, Secretary of Health

Potential measles exposure reported in Hot Springs

Chris Sain President

North Carolina Board of Pharmacy schedules July meeting with live stream option

Cecil H.  Cordle Georgia Board Of Pharmacy President

Pharmacy license expiry extended due to payment issues

Copyright © 2025 American Pharmacy News. All Rights Reserved.

  • About
  • Contact
  • Privacy Policy
  • Terms of Service

Alerts Sign-up