The new preventive medicine for migraine Aimovig (erenumab) has been approved by the EMA. Read more...
 

The latest approval renders the previous 'temporary approval' a full approval, without further results needed.

The FDA has approved a wearable device to treat withdrawal symptoms such as agitation, anxiety, depression, and opiate cravings.

Tagrisso (osimertinib) has been approved in Europe to treat Epidermal Growth Factor Receptor (EGFR) mutated non-small cell lung cancer (NSCLC) as a first-line treatment. 

This will provide a much-needed alternative therapy for a debilitating disease with limited treatment options. 



Moderately to severely active ulcerative colitis can now be treated with Xeljanz (tofacitinib), following the expanded approval by the Food and Drug Administration (FDA). This will provide a much-needed alternative therapy for a debilitating disease with limited treatment options.

This new development may increase chances of patients discussing the disease with their doctor...



A new package insert that includes information/data about psoriasis in the genital area has been approved by the Food and Drug Administration (FDA). 

‘Unapproved medicines’, ‘compassionate use’, ‘early access drugs’..

Rubraca (rucaparib), already approved as a treatment for BRCA positive ovarian cancer, has been approved as a maintenance therapy for ovarian cancer regardless of BRCA mutation. 

The FDA approves Blincyto (blinatumomab) for patients with B-cell ALL, who are in remission but still have minimal residual disease.

FDA approves Tasigna (nilotinib) for certain pediatric patients with Ph+ CML in chronic phase.

FDA approves Genentech’s Lucentis (ranibizumab injection) syringe for diabetic macular edema and diabetic retinopathy.

FDA expands approval of Adcetris (brentuximab vedotin) for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy.

The FDA has approved a new HIV treatment for patients with limited treatment options.

The Food and Drug Administration (FDA) have extended the approval of Verzenio (abemaciclib) to now be a first line treatment for some types of advanced or metastatic breast cancer.

FDA Approves Osmolex ER (amantadine) for the treatment of Parkinson’s Disease and Drug-Induced Extrapyramidal Reactions. 

Imfinzi (durvalumab), already approved for some bladder cancers, is now FDA approved for some patients with lung cancer.

The FDA has approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread, but that continues to grow despite treatment with hormone therapy.

The Scottish Medicines Consortium (SMC) has approved Mavenclad (cladribine) as a treatment for highly active relapsing multiple sclerosis.

The experimental drug from Roche (balovaptan) has now been given Breakthrough Therapy Designation, potentially placing the drug on a faster path to market as the first pharmacological treatment for autism spectrum disorder (ASD). Pharmatimes, 30/01/2018.

Following the EMA’s approval in late 2017, the FDA has now also approved Lutathera (lutetium Lu 177 dotatate) for certain digestive tract cancers.

The potential of neuroprotective agents for a whole new form of treatment.

Brentuximab vedotin (Adcetris) has now been approved by the European Commission for the treatment of patients with CD30-positive cutaneous T-cell lymphoma (CTCL) who have had at least 1 prior systemic therapy.

Ocrevus (ocrelizumab), the first ever FDA approved medicine for primary progressive MS has now also been approved by the EMA.

Is there substance to the claims that it's a groundbreaking treatment?

The FDA has approved the first biosimilar for the treatment of certain breast and stomach cancers.

A phase 3 study on lung cancer showed that Imfinzi (durvalumab) as a consolidation therapy reduced the risk of the disease progressing by 48 percent.

FDA approves Juluca (dolutegravir and rilpivirine) for the maintenance treatment of certain patients with HIV-1 infection.