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EMA panel recommends against clot prevention drug

A panel of European Medicines Agency recommended against granting marketing approval to Portola Pharmaceuticals Inc.’s oral blood thinner, saying the benefits of the drug did not outweigh risks.

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Two-drug HIV regimen wins EU panel approval

A panel of European Medicines Agency recommended approval for GlaxoSmithKline’s two-drug regimen to treat HIV, the virus that causes AIDS.

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Galafold Approved for Fabry Disease in Japan

Amicus Therapeutics announced that Japan’s Ministry of Health, Labour and Welfare approved the oral small molecule pharmacological chaperone Galafold capsules 123mg (migalastat).

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Novartis drug Tasigna approved by FDA to treat children with rare form of leukemia

Novartis announced that the U.S. Food and Drug Administration expanded the indication for Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase.

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Hodgkin’s lymphoma drug receives U.S. approval

U.S. regulators approved Seattle Genetics Inc.’s Adcetris as part of a chemotherapy cocktail to treat advanced Hodgkin’s lymphoma in newly diagnosed patients.

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Arena Reports Positive Ulcerative Colitis Trial Data

Arena Pharmaceuticals Inc.’s shares rose 34 percent after the company released positive top-line results from its Phase II trial of etrasimod in ulcerative colitis.

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FDA Grants Priority Review for Prostate Cancer Treatment

A supplemental New Drug Application was accepted by the U.S. FDA for Pfizer and partner Astellas Pharma’s Xtandi as a treatment for non-metastatic Castration-Resistant Prostate Cancer (CRPC).

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FDA Places Clinical Hold on DMD Gene Therapy

A U.S. Food and Drug Administration decision to slap a clinical hold on Solid Biosciences’s experimental gene therapy treatment for Duchenne muscular dystrophy sent share prices plunging.

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Keytruda Granted Priority Review for Cervical Cancer

The U.S. FDA accepted Merck & Company’s supplemental Biologics License Application and granted Priority Review for Keytruda (pembrolizumab) in advanced cervical cancer.

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FDA Halts Advaxis Study Following Patient Death

Shares of Advaxis Inc. were down more than 21 percent in after the company announced that the U.S. FDA halted a Phase I/II trial that uses an AstraZeneca Pharmaceuticals LP drug following the death of a patient.

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AcelRx Plans to Resubmit NDA for Dsuvia

AcelRx Pharmaceuticals intends to resubmit a New Drug Application for Dsuvia (sufenetanil sublingual tablet) for pain in Q2 2018 after receiving a Complete Response Letter in October 2017.

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FDA panel backs Xeljanz as bowel disease treatment

Pfizer Inc.’s Xeljanz should be approved to treat patients with moderate to severe ulcerative colitis, a chronic bowel disease, a U.S. Food and Drug Administration advisory committee concluded.

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FDA Approves Multi-Drug Resistant HIV-1 Treatment

Shares of Theratechnologies and TaiMed Biologics jumped after the U.S. Food and Drug Administration green lit Trogarzo (ibalizumab), the first HIV-1 inhibitor for patients with multi-drug resistant HIV-1.

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FDA Grants Sunovion’s Latuda Expanded Approval

The FDA approved a supplemental NDA that expands the use of Sunovion’s Latuda to include treating major depressive episode associated with bipolar I disorder in pediatric patients.

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FDA approves new dosing for Bristol-Myers’ Opdivo

Bristol-Myers Squibb Co. said the U.S. Food and Drug Administration approved a four-week dosing schedule for its cancer drug Opdivo.

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FDA to Review Dupixent for Severe Asthma

The U.S. FDA accepted for review the supplemental BLA of Dupixent (dupilumab) as an add-on maintenance treatment in certain adults and adolescents with moderate-to-severe asthma.

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FDA Delays Review of Portola’s Factor Xa Inhibitor

Shares of Portola Pharmaceuticals fell more than 27 percent after the company announced a delay of several months for possible regulatory approval of its factor Xa inhibitor antidote AndexXa.

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FDA approves Sorrento’s non-opioid painkiller patch

The U.S. Food and Drug Administration approved ZTlido, Sorrento Therapeutics Inc.’s non-opioid painkiller patch for nerve pain related to shingles.

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European regulators to help early Alzheimer’s drugs

The European Medicines Agency is following in the footsteps of the U.S. Food and Drug Administration with plans to help pharma companies win approval for novel Alzheimer’s drugs.

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U.S. FDA rejects filing for Celgene MS drug, shares fall

U.S. health regulators rejected Celgene Corp.’s application seeking approval of a key multiple sclerosis drug due to insufficient data, the company said.

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