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Collegium Announces FDA Tentative Approval for Xtampza(TM) ER, a Novel Abuse-Deterrent Analgesic for Chronic Pain

DosageCollegium2015-11-10 15:26 Read   718

Collegium Pharmaceutical, Inc. today announced that the United States Food and Drug Administration (FDA) has granted tentative approval to the Company's New Drug Application (NDA) for Xtampza(TM) ER (oxycodone) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

RedHill Biopharma and IntelGenx Announce First European Marketing Approval of RIZAPORT (RHB-103) for Migraines

DosageRedHill2015-11-10 10:47 Read   432

 The national approval of RIZAPORT™ in Germany was granted under the European Decentralized Procedure (DCP), in which Germany served as the Reference Member State. This authorization is the first national marketing approval of RIZAPORT™.

FDA approves new treatment for HIV

New CombinationFDA2015-11-06 10:56 Read   343

The U.S. Food and Drug Administration today approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

GlaxoSmithKline bags an FDA OK for its asthma drug with eyes on a respiratory turnaround

BLA Approvalstatement2015-11-05 15:16 Read   357

GlaxoSmithKline won FDA approval for an antibody designed to treat severe asthma.

FDA approves new Novartis dual combination bronchodilator Utibron™ Neohaler® for patients with chronic obstructive pulmonary disease

BLA ApprovalPipelinereview2015-11-02 18:31 Read   580

October 29, 2015 I Novartis announced today that FDA has approved the dual combination bronchodilator Utibron™ Neohaler (indacaterol/glycopyrrolate) inhalation powder for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)

Celgene’s VIDAZA® (Azacitidine for Injection) Approved by the European Commission as New Treatment for Elderly Patients with Acute Myeloid Leukaemia

IndicationPipelinereview2015-11-01 15:40 Read   522

Expanded indication brings medicine to greater number of elderly AML patients who are not eligible for haematopoietic stem cell transplantation and have >30% myeloblasts in their bone marrow

Bayer Receives EU Approval for EYLEA® for the Treatment of Visual Impairment Secondary to Myopic Choroidal Neovascularization

MarketBayer2015-11-01 13:43 Read   635

Bayer has received approval from the European Commission for the eye drug EYLEA(aflibercept solution for injection into the eye) in a fifth indication.

FDA approves Yervoy to reduce the risk of melanoma returning after surgery

BLA ApprovalFDA2015-10-29 18:26 Read   246

Today FDA expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery.

FDA approves first-of-its-kind product for the treatment of melanoma

BLA ApprovalFDA2015-10-28 17:06 Read   1173

The U.S. Food and Drug Administration today approved Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes.

Iroko Pharmaceuticals Receives FDA Approval for VIVLODEX- First Low Dose SoluMatrix? Meloxicam for Osteoarthritis Pain

Dosagepipelinereview2015-10-26 13:53 Read   480

October 23, 2015, Iroko Pharmaceuticals, LLC announced today that the United States Food and Drug Administration (FDA) approved VIVLODEX (meloxicam) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain in 5 mg and 10 mg doses administered once daily.

FDA approves new treatment for rare metabolic disorder

Pediatric ApprovalFDA2015-10-24 16:23 Read   282

Oct 23, 2015, the U.S. Food and Drug Administration approved Strensiq (asfotase alfa) as the first approved treatment for perinatal, infantile and juvenile-onset hypophosphatasia (HPP). 

FDA approves new therapy for certain types of advanced soft tissue sarcoma

MarketFDA2015-10-24 16:13 Read   543

The U.S. Food and Drug Administration today approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic).