USFDA

The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.

The U.S. Food and Drug Administration expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the first FDA-approved therapy, specific to this type of vasculitis.

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Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a company that is developing innovative pharmaceutical products to address public health challenges, presented entitled “Phase 2 Multisite Double-Blind Placebo-Controlled Trial of TNX-102 SL in Military-Related Posttraumatic Stress Disorder: Mediators and Moderators of Treatment Response” (Poster No. 3001130) at the 72nd Annual Scientific Convention of the Society of Biological Psychiatry in San Diego. The poster can be found on the Scientific Presentations page on Tonix’s website. A moderator is a characteristic of study participants that is associated with a treatment response.

Alembic Pharmaceuticals Limited announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fenofibric Acid Delayed-Release Capsules, 45 mg and 135 mg.

The U.S. Food and Drug Administration approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease.

The US Food and Drug Administration (FDA) has posted warning letters to 14 US companies that illegally sell more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without the approval of the FDA, most often on websites and social media

Alembic Pharmaceuticals Limited announced that the Company has received final approvals from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Applications (ANDAs) for Olmesartan Medoxomil Tablets, 5 mg, 20mg and 40mg and Olmesartan Medoxomil with Hydrochlorothiazide Tablets 20/12.5mg, 40/12.5mg and 40/25mg.

Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it has launched Progesterone Capsules, 100 mg and 200 mg, a therapeutic equivalent generic version of Prometrium® (Progesterone) Capsules in the United States market, approved by the U.S. Food and Drug Administration (USFDA).

AstraZeneca announced that the US Food and Drug Administration (FDA) has granted full approval for Tagrisso (osimertinib) 80mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after an EGFR tyrosine kinase inhibitor (TKI) therapy. Tagrisso is the first and only approved medicine in the US indicated for NSCLC patients who have tested positive for the EGFR T790M mutation, and efficacy data suggest it may be a new standard of care for these patients.

The U.S. Food and Drug Administration approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved to treat HCV in adults.