• Roche,RoACTEMRA,methotrexate,RA

Roche announced today that RoACTEMRA (tocilizumab) has received approval from the European Commission for use in patients with severe, active and progressive RA who previously have not been treated with methotrexate (MTX).

Read more

  • Pembrolizumab,FDA,melanoma,Keytruda

Today the FDA approved Keytruda (pembrolizumab), a new treatment for advanced melanoma, the deadliest form of skin cancer. Melanoma patients have been waiting anxiously for this day, given the promising data that early studies have shown.

Read more

  • Takeda,FDA,pioglitazone,pioglitazone HCl,Medical

Takeda Announces Completion of the Post-Marketing Commitment to Submit Data to the FDA, the EMA and the PMDA for Pioglitazone Containing Medicines Including ACTOS No overall statistically significant increased risk of bladder cancer in patients ever exposed to pioglitazone in a completed 10-year epidemiological study.

Read more

  • Jardiance,Boehringer Ingelheim,Lilly

Jardiance(empagliflozin) tablets are now available by prescription in pharmacies across the United States, including Walgreens, Rite Aid, Kroger and many other leading chain and independent retailers, according to Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY).

Read more

  • GSK,Promacta,eltrombopag,FDA

FDA has approved a supplemental New Drug Application (sNDA) for the once-daily use of Promacta(eltrombopag) in patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).

Read more

  • GlaxoSmithKline,gsk,Arnuity Ellipta,FDA

GlaxoSmithKline plc today announced that the Food and Drug Administration has approved Arnuity? Ellipta?, a once-daily inhaled corticosteroid medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older.

Read more

  • Bristol-Myers Squibb,nivolumab,PD-1

Bristol-Myers Squibb ($BMY) and Celgene ($CELG) are joining forces on a cancer combination treatment, testing the former's highly anticipated immunotherapy in tandem with an on-the-market chemo drug against a host of tumor targets.

Read more

  • AstraZeneca,CAZ-AVI,cIAI

AstraZeneca today announced positive top-line results from RECLAIM-1 and RECLAIM-2, the pivotal Phase III studies investigating the potential of the antibiotic ceftazidime-avibactam (CAZ-AVI) as a treatment for hospitalised adult patients with complicated intra-abdominal infections.

Read more

Categories

Recent News

Merck Announces FDA Acceptance of Biologics License Application for Bezlotoxumab, an Investigational Antitoxin for Prevention of Clostridium Difficile Infection Recurrence

Merck announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence.

Sanofi and Regeneron Announce Sarilumab Biologics License Application Accepted for Review by US FDA

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sarilumab.

First data backs efficacy of BMS' novel HIV drug

A Bristol-Myers Squibb (BMS) drug that causes immature HIV particles to be released from cells early, interrupting their lifecycle, has cleared a proof-of-concept study.

EU Rules Could Restrict Genetic Testing

Genetic testing describes the application of laboratory methods to look at a person’s genes (the inherited DNA instructions). Genetic tests can be used to diagnose a genetic condition; screen for a risk of developing a particular health problems; for the selection of treatments; or to assess responses to treatments.

CHMP adopts positive opinion of Edurant in adolescents with HIV-1

The CHMP has adopted a positive opinion recommending a change to the terms of the marketing authorisation for Janssen’s Edurant (rilpivirine) in the EU to extend the indication to adolescent patients aged 12 to <18 years with human immunodeficiency virus-1 (HIV-1) infection

FDA finds mystery 'deficiencies' with Neos' long-acting Ritalin on the eve of approval

Neos Therapeutics got an ominous note from the FDA just weeks ahead of the expected approval date for its long-acting ADHD treatment, clouding the future of the company's lead asset.

Pfizer's once-failed cancer drug wins the FDA's 'breakthrough' tag

Pfizer has found new hope for a former pipeline standout, picking up the FDA's coveted breakthrough therapy designation for a Phase III reclamation project in oncology.