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

FDA approves fingernail psoriasis data for Humira

American Pharmacy News Reports | Apr 3, 2017
Fingernail psoriasis affects half of all psoriasis patients.

AbbVie has received approval from the U.S. Food and Drug Administration to include moderate to severe fingernail psoriasis data in the Humira (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis. Read More »

FDA approves benefit-risk ratio for Genentech blood cancer drug

American Pharmacy News Reports | Apr 1, 2017
The FDA should make a decision on whether to approve Rituxan by June 26.

The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee voted 11-0 on a favorable benefit-risk ratio for Genentech's rituximab/hyaluronidase subcutaneous injections in treating certain blood cancers. Read More »

Tildrakizumab filing with European agency validated

American Pharmacy News Reports | Mar 29, 2017
The Phase III clinical trials included in the filing had more than 1,800 participants.

The regulatory filing of investigational IL-23p19 inhibitor tildrakizumab with the European Medicines Agency was validated last week, according to Almirall and Sun Pharmaceutical Industries. Read More »

Pfizer's TRUMENBA moves closer to European approval

American Pharmacy News Reports | Mar 29, 2017
Data showed TRUMENBA produced a protective serum antibody response to meningococcal group B strains.

Pfizer Inc.'s meningococcal group B vaccine TRUMENBA has received a positive opinion from the European Medicines Agency Committee for Medicinal Products for Human Use. Read More »

European Commission approves XELJANZ for rheumatoid arthritis

American Pharmacy News Reports | Mar 29, 2017
The EC approval was based in part on the results of the Phase III Oral Rheumatoid Arthritis Trials.

XELJANZ (tofacitinib citrate) has been approved by the European Commission in mono or combination therapy for rheumatoid arthritis. Read More »

Rituxan receives breakthrough status from FDA

American Pharmacy News Reports | Mar 28, 2017
Genentech's Phase 3 study is enrolling patients.

Genentech's drug Rituxan was recently granted Breakthrough Therapy Designation Status by the U.S. Food and Drug Administration. Read More »

Bavencio treatment for Merkel cell carcinoma patients gains FDA approval

American Pharmacy News Reports | Mar 28, 2017
The FDA’s approval comes after the conclusion of the Javelin Markel 200 trial.

EMD Serano, the biopharmaceutical business of Merck KGaA, and Pfizer Inc. recently received approval from the U.S. Food and Drug Administration to market Bavencio Injection 20 mg/mL for intravenous use. Read More »

FDA fast-tracks Shire's SHP655 for patients with ADAMTS13

American Pharmacy News Reports | Mar 27, 2017
Shire noted that this does not guarantee FDA approval.

Shire PLC's recombinant ADAMTS13 drug, SHP655, has been given fast-track designation by the U.S. Food and Drug Administration. Read More »

Allergan to sell FDA-approved Restasis in first multi-dose bottle

American Pharmacy News Reports | Mar 27, 2017
Restasis Multidose, which is designed with new and patented air filter technology, will be available for the same price of single-use vials.

Restasis MultiDose will now be available and approved by the U.S. Food and Drug Administration for help treating patients with a type of Chronic Dry Eye by helping them make more of their own tears. Read More »

Allergan's Juvéderm Vollure XC approved for sale in the U.S.

American Pharmacy News Reports | Mar 25, 2017
Juvéderm Vollure XC will be available in the U.S. starting in April.

The U.S. Food and Drug Administration has approved Allergan PLC’s Juvéderm Vollure XC for use correcting moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over 21. Read More »

FDA tentatively OKs Mylan's HIV/AIDS drug for developing nations

American Pharmacy News Reports | Mar 25, 2017
Developing countries will now be able to use the drug as a first-line regimen for treating HIV/AIDS patients.

Mylan N.V., a global pharmaceutical company, recently announced the U.S. Food and Drug Administration (FDA) tentatively approved the company's New Drug Application for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg ("TLE400"). Read More »

Amgen receives European approval to market Amgevita

American Pharmacy News Reports | Mar 24, 2017
Amgevita treats select inflammatory diseases in adults, such as moderate-to-severe rheumatoid arthritis.

Amgen recently announced that the European Commission (EC) granted the company authorization to bring to market Amgevita in all available indications. Read More »

DEA rule would classify Syndros drug as controlled substance

American Pharmacy News Reports | Mar 24, 2017
The product is a cannabinoid that can be used to help treat anorexia in patients with AIDS.

An interim final rule introduced by the Drug Enforcement Agency would result in Insys Therapeutics Inc.'s Syndros product being placed in Schedule II of the Controlled Substances Act. Read More »

Amgen unveils positive data from Phase 3 '482 study

American Pharmacy News Reports | Mar 20, 2017
Multiple myeloma develops within plasma cells in bone marrow.

Amgen recently announced positive data from the Phase 3 '482 study, which is the largest international multiple myeloma trial ever conducted. Read More »

Abbot receives FDA approval for its FlexAbility ablation catheter

American Pharmacy News Reports | Mar 17, 2017
The FDA’s approval is a further step in the company’s electrophysiology portfolio expansion.

Abbot recently announced that the U.S. Food and Drug Administration (FDA) approved its FlexAbility Ablation Catheter. Read More »

Pfizer's combination antibiotic approved in U.K., Germany

American Pharmacy News Reports | Mar 17, 2017
Zaficefta is a useful tool in treating infections that are increasingly resistant to available antibiotics.

Pfizer Inc.'s combination antibiotic Zavicefta is now available in the United Kingdom and Germany for the treatment of Gram-negative bacterial infections requiring hospitalization. Read More »

FDA accepts application for Keryx Pharmaceutical's Auryxia

American Pharmacy News Reports | Mar 16, 2017
Keryx Biopharmaceuticals specializes in innovative medicines to fight renal disease.

The U.S. Food and Drug Administration has accepted a supplemental New Drug Application for Auryxia tablets from Keryx Biopharmaceuticals Inc., a company specializing in innovative medicines to fight renal disease. Read More »

Pfizer China’s XELJANZ approved for rheumatoid arthritis treatment

American Pharmacy News Reports | Mar 16, 2017
JAK disrupt a signalling pathway that is believed to play a role in RA-associated inflammation.

Chinese authorities recently approved Pfizer China’s oral Janus kinase inhibitor XELJANZ, with active ingredient tofacitinib citrate, indicated for treating adults with moderate to severely active rheumatoid arthritis. Read More »

Data shared from Phase 3 study on DUPIXENT treatment of atopic dermatitis

American Pharmacy News Reports | Mar 16, 2017
Patients who received DUPIXENT in combination with TCS had significantly higher baseline improvements.

Regeneron Pharmaceutical Inc. and Sanofi recently presented the results of their one-year Phase 3 CHRONOS study, showing that investigational drug DUPIXENT combined with topical corticosteroids achieved better results in treating uncontrolled moderate-to-severe atopic dermatitis than TCS alone. Read More »

Mylan launches Exemestane tablets in U.S. market following FDA approval

American Pharmacy News Reports | Mar 16, 2017
Exemestane tablets garnered approximately $100 million in sales between February 2016 and the end of January 2017.

The U.S. Food and Drug Administration recently issued its final approval for Mylan’s Abbreviated New Drug Application for its Exemestane Tablets in a 25mg dosage, which are a generic version of Pfizer’s Aromasin tablets. Read More »

  • «
  • 1
  • 2
  • ...
  • 11
  • 12
  • 13 (current)
  • 14
  • 15
  • 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