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FDA approves new oral medication to treat patients with advanced colorectal cancer

CombinationPharmacodia.com2015-09-23 00:00 Read   512

The U.S. Food and Drug Administration approved Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies in Sep 22, 2015.

Shire Receives European Approval for INTUNIV® (guanfacine hydrochloride prolonged release tablets) as a Non-stimulant ADHD Treatment for Children and Adolescents

MarketPharmacodia.com2015-09-21 00:00 Read   690

 Shire  today announced that the European Commission granted Marketing Authorisation for once-daily, non-stimulant INTUNIV (guanfacine hydrochloride prolonged release tablets) for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective.

FDA approves new drug to treat schizophrenia and bipolar disorder

NCE ApprovalPharmacodia.com2015-09-17 00:00 Read   495

The U.S. Food and Drug Administration today approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults.

FDA Approves Octapharma's NUWIQ for the Treatment of Adults and Children with Hemophilia A

BLA ApprovalPharmacodia.com2015-09-14 00:00 Read   929

Octapharma USA announced the U.S. FDA has approved NUWIQ?, Antihemophilic Factor (Recombinant), an intravenous therapy for adults and children living with Hemophilia A. The NUWIQ? approval includes on-demand treatment and control of bleeding episodes; routine prophylaxis to reduce the frequency of bleeding episodes; and perioperative management of bleeding.

Santhera Receives European Marketing Authorization for Raxone in Leber’s Hereditary Optic Neuropathy (LHON)

IndicationPharmacodia.com2015-09-09 00:00 Read   601

First Approved Treatment for LHON and First Approved Treatment for a Mitochondrial Disease.

FDA approves new orphan drug to treat rare autosomal recessive disorder

NCE ApprovalPharmacodia.com2015-09-04 00:00 Read   704

In Sep 4, 2015, the U.S. Food and Drug Administration approved Xuriden (uridine triacetate), the first FDA-approved treatment for patients with hereditary orotic aciduria. Hereditary orotic aciduria is a rare metabolic disorder, which has been reported in approximately 20 patients worldwide.

US FDA approves expanded indication for Brilinta to include long-term use in patients with a history of heart arrack

IndicationPharmacodia.com2015-09-03 00:00 Read   704

US FDA has handed down an approval for AstraZeneca’s blood thinner Brilinta expanding indication of long-term use of the drug in patients who have previously suffered heart attacks, in Sep 3, 2015.

U.S. FDA approves new drug treatment for nausea and vomiting from chemotherapy

NCE ApprovalPharmacodia.com2015-09-02 00:00 Read   666

The U.S. Food and Drug Administration approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherap.

Novartis receives EU approval for Tafinlar and Mekinist, first combination approved for patients with aggressive form of melanoma

New CombinationPharmacodia.com2015-09-01 00:00 Read   716

Novartis today announced that the European Commission has approved the combination of Tafinlar? (dabrafenib) and Mekinist? (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

FDA extends use of Promacta in young children with rare blood disorder

Pediatric ApprovalPharmacodia.com2015-08-24 00:00 Read   522

The U.S. Food and Drug Administration approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP).

FDA approves first treatment for sexual desire disorder

NCE ApprovalPharmacodia.com2015-08-18 00:00 Read   345

The U.S. Food and Drug Administration approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

U.S. FDA approved Technivie (ombitasvir/paritaprevir/ritonavir) in combination with ribavirin for the treatment of HCV genotype 4 infections without cirrhosis.

CombinationPharmacodia.com2015-07-24 00:00 Read   459

On July 24, 2015, U.S. FDA approved Technivie (ombitasvir/paritaprevir/ritonavir) in combination with ribavirin (RBV) for the treatment of genotype 4 (GT4) HCV infection without cirrhosis. Technivie is the first and only all-oral, interferon-free, direct-acting antiviral treatment approved in the U.S. for adult patients with GT4 chronic HCV infection.