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U.S. FDA Approves Expanded Use of Bristol-Myers Squibb’s Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C

IndicationBristol-Myers Squibb Company2016-02-09 15:59 Read   244

Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza™ (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3.

FDA Approves Merck’s Single-Dose EMEND® (fosaprepitant dimeglumine) for Injection, in Combination with Other Antiemetic Agents, for the Prevention of Delayed Nausea and Vomiting in Adults Receiving Moderately Emetogenic Chemotherapy (MEC)

DosageMerck2016-02-05 11:21 Read   303

FDA Approves Merck’s Single-Dose EMEND® (fosaprepitant dimeglumine) for Injection, in Combination with Other Antiemetic Agents, for the Prevention of Delayed Nausea and Vomiting in Adults Receiving Moderately Emetogenic Chemotherapy (MEC)

TAGRISSO™ (osimertinib) approved in EU as first-in-class treatment for patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer

NCE ApprovalAstraZeneca2016-02-04 09:28 Read   583

AstraZeneca today announced that the European Commission (EC) has granted conditional marketing authorisation for TAGRISSO™ (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).

European Commission Approves Daklinza (daclatasvir) for the Treatment of Genotype 1, 3 and 4 Chronic Hepatitis C Patients with HIV Coinfection, Advanced Cirrhosis and Post-liver Transplant Recurrence of HCV

IndicationBristol-Myers Squibb2016-02-02 08:35 Read   194

European Commission Approves Daklinza (daclatasvir) for the Treatment of Genotype 1, 3 and 4 Chronic Hepatitis C Patients with HIV Coinfection, Advanced Cirrhosis and Post-liver Transplant Recurrence of HCV

OptiNose Announces FDA Approval for ONZETRA™ Xsail™ (sumatriptan nasal powder), a New Treatment for Acute Migraine Using Bi-Directional™ Breath Powered® Technology

RouteOptiNose2016-02-01 16:11 Read   1115

OptiNose, a privately-held specialty biopharmaceutical company, today announced that its licensing partner, Avanir Pharmaceuticals, Inc. has reported that the U.S. Food & Drug Administration (FDA) approved ONZETRA™ Xsail™ (sumatriptan nasal powder), formerly AVP-825, for the acute treatment of migraine with or without aura in adults (see Full Prescribing Information and Limitations of Use at www.ONZETRA.com).

FDA Approves Takeda's Dexilant SoluTab (dexlansoprazole)

DosageTakeda2016-02-01 15:48 Read   317

New melt in your mouth tablet for appropriate adult patients with heartburn associated with Gastroesophageal Reflux Disease (GERD)

Avanir Pharmaceuticals Announces FDA Approval of ONZETRA™ Xsail™ (AVP-825) for the Acute Treatment of Migraine in Adults

RouteAvanir2016-02-01 15:48 Read   591

Avanir Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ONZETRA™ Xsail™ (sumatriptan nasal powder), formerly known as AVP-825, for the acute treatment of migraine with or without aura in adults.

FDA approves first drug to show survival benefit in liposarcoma

NCE ApprovalFDA2016-01-30 08:17 Read   161

The U.S. FDA today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic).

FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1 and 4

CombinationFDA2016-01-29 10:15 Read   227

The U.S. FDA today approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.

Takeda Announces New Drug Application Approval in Japan for a Haemophilus influenzae type b conjugate vaccine, "VAXEM Hib®"

BLA ApprovalTakeda2016-01-29 08:34 Read   237

Takeda Pharmaceutical Company Limited  today announced that the Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application (“NDA”) for a conjugate vaccine to prevent infections caused by Haemophilus influenzae type b (Hib) in children aged from 2 months to under 5 years of age.

Bristol-Myers Squibb’s Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status

ExpansionBristol-Myers Squibb2016-01-28 09:00 Read   170

Bristol-Myers Squibb Companytoday announced that FDAhas approvedOpdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma.

FDA approves new Kyprolis® (carfilzomib) combination therapy for the treatment of patients with relapsed or refractory multiple myeloma

New CombinationAmgen2016-01-27 09:01 Read   155

Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of Kyprolis® (carfilzomib) for Injection in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.