Gilead has announced the July 23, 2014 Idelalisib FDA approved news. The Idelalisib (or the brand name Zydelig) approval was long awaited, to combat three forms of blood cancer. The FDA extended a nod to this powerful drug, which is estimated to earn roughly 1.2 billion dollars by the year 2020. Approved to treat three type[…]
Idelalisib FDA Approved to Combat Three Blood Cancers
Chemotherapeutic / Anti-Neoplastic, Drug Research & Development API, FDA Approved 2014 Tags: chronic lymphocytic leukemiaIdelalisibRituximab Jul 28, 2014
Belinostat Early Approval for Lymphoma is Welcomed By Many
Chemotherapeutic / Anti-Neoplastic, Drug Research & Development API, FDA Approval News, FDA Approved 2014 Jul 03, 2014
The accelerated approval of Belinostat by the FDA on July 3, 2014 is exciting news for the medical and pharmaceutical communities. Known as the brand name Beleodaq, which is marketed by Topotarget, Belinostat is expected to be available for patients by the end of July 2014. As a formidable treatment for unresectable or relapsed peripheral[…]
FDA Approves Dalbavancin for the Treatment of Acute Skin Infections
Antibacterial, Antibiotic, Drug Research & Development API, FDA Approved 2014 Tags: antibiotic Jun 12, 2014
Exciting news was announced at the end of May 2014 from Durata Therapeutics with the FDA approval of Dalbavancin, their novel antibiotic treatment. Known as the brand name Dalvance, the FDA nod for Dalbavancin meets a current need for new, safe and efficacious antibiotics. Dalbavancin is officially approved to treat skin structure and bacterial skin infections[…]
FDA Approves Ketorolac and Phenylephrine for Eye Surgery
Anti-Inflammatory, Antibacterial, Drug Research & Development API, FDA Approved 2014, OTC and Compounding Product Tags: high blood pressureintraocular pressure Jun 09, 2014
Approximately four million Americans undergo cataract surgery every year, so the recent FDA approval of Ketorolac and Phenylephrine on June 2, 2014 is timely and beneficial for many patients in the United States. Known as the brand name Omidria, the combination of Ketorolac and Phenylephrine to create an efficacious pupil-dilating agent has been deemed successful[…]
FDA Grants Accelerated Approval to Ceritinib For ALK- Positive NSCLC
Chemotherapeutic / Anti-Neoplastic, Drug Research & Development API, FDA Approved 2014 Tags: Crizotinib Jun 09, 2014
Phase 1 clinical trial results for Ceritinib have revealed affirmative results, leading the FDA to grant an accelerated approval for this impressive drug. Deemed to be “highly active” in the fight against ALK-rearranged non-small-cell lung cancer, Ceritinib is also twenty times more potent than Crizotinib. The exciting results from Novartis’s Phase 1 trial were recently[…]
FDA Approves Pivotal Cardiovascular Drug Vorapaxar
Antithrombotic, Cardiovascular Agent, Drug Research & Development API, FDA Approved 2014 Tags: Drug Administration May 15, 2014
On May 8, 2014 the U.S. Food and Drug Administration approved the formidable cardiovascular drug Vorapaxar. Known as the brand name Zontivity, which is marketed by Merck, this pivotal medication has proven to be outstanding in clinical trials. In three short years of study Vorapaxar demonstrated its ability to successfully reduce the rate of death[…]
Ofatumumab FDA Approved to Treat Chronic Lymphocytic Leukemia
Chemotherapeutic / Anti-Neoplastic, Drug Research & Development API, FDA Approved 2014, Monoclonal Antibodies / mAb Tags: chronic lymphocytic leukemia May 06, 2014
The recent approval of Ofatumumab by the FDA is exciting news for the medical and pharmaceutical world. As a monoclonal antibody used to treat chronic lymphocytic leukemia, Ofatumumab garnished a Supplemental Biologic License Application in late April 2014. Known as the brand name drug Arzerra, which is marketed by both GlaxoSmithKline and Genmab this unique[…]
EU Approves Albiglutide for Type 2 Diabetes
Anti-Diabetic, FDA Approved 2014 Tags: EUGlaxoSmithKline Apr 07, 2014
On March 27, 2014, the EU announced their approval of Albiglutide for patients diagnosed with Type 2 Diabetes. This approval was expected by GlaxoSmithKline, as Albiglutide, known as their brand name drug Eperzan, received a positive opinion from the EU at the commencement of 2014. The unique ability of Albiglutide to act as an effectual[…]
Metronidazole 1.3% Gel Approved by the FDA for BV
Antibacterial, FDA Approved 2014, OTC and Compounding Product Tags: antibiotic Apr 02, 2014
On March 25, 2014 Actavis and Valeant Pharmaceuticals announced the FDA approval of Metronidazole 1.3% gel for the antibiotic treatment of Bacterial Vaginosis. Bacterial Vaginosis, or BV, is an extremely common vaginal infection which commonly affects women between the ages of 15 and 44. An imbalance of normal bacteria in the vagina is the leading[…]
Propranolol Hydrochloride U.S. & E.U. Approved to Treat Infantile Hemangioma
Anti-Migraine, Drug Research & Development API, EU Approved 2014, FDA Approved 2014 Tags: EU Mar 28, 2014
UPDATE: On May 6, 2014, Propranolol was approved by the European Commission for treatment of infantile hemangioma. Infantile hemangioma, or an overgrowth of blood vessels on or under the skin of infants is a benign vascular condition. As a common non-life threatening tumor of the skin, infantile hemangioma occur during the first four weeks of[…]
