FDA approve new daily pill for common skin cancer
The US regulators have approved a new drug for the treatment of locally advanced basal cell carcinoma a form of skin cancer.
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Opdivo Approved for Advanced Kidney Cancer
Opdivo (nivolumab) has been approved to treat advanced renal cell carcinoma, the most common type of kidney cancer. The drug targets proteins that would otherwise hinder the body's...
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FDA Approves Basaglar
FDA Approves Basaglar (insulin glargine) for Type 1 and Type 2 Diabetes The U.S. Food and Drug Administration today approved Basaglar (insulin glargine injection), a long-acting hu...
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Noxafil (posaconazole): Drug Safety Communication
The FDA is cautioning that differences in dosing regimens between the two oral formulations of the antifungal Noxafil (posaconazole) have resulted in dosing errors. To help prevent...
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The Top Five New Drug Approvals From 2015
This past year close to 100 new drugs were FDA-approved, so it’s encouraging to look back and see the progress that’s been made as 2015 ends. In fact, more than 40 novel drugs, inc...
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FDA Approves New Kyprolis (Carfilzomib)
Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of Kyprolis (carfilzomib) for Inject...
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FDA Approves Adzenys XR-ODT
Neos Therapeutics Announces FDA Approval of Adzenys XR-ODT (Amphetamine Extended-Release Orally Disintegrating Tablet) for ADHD
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insulin glargine and lixisenatide
FDA Accepts Sanofi NDA for Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Sanofi announced today that the U.S. Food and Drug Administration (FDA) has accep...
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FDA Approves Xeljanz XR
Pfizer Announces FDA Approval of Xeljanz XR (tofacitinib citrate), the First and Only Once-Daily Oral JAK Inhibitor Treatment for Rheumatoid Arthritis
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FDA Approves Evomela
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology,...
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The Top Five New Drug Approvals From 2015
This past year close to 100 new drugs were FDA-approved, so it’s encouraging to look back and see the progress that’s been made as 2015 ends. In fact, more than 40 novel drugs, inc...
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Eisai Announces FDA Approval of Fycompa (perampanel) Oral Suspension
Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Fycompa (perampanel) CIII Oral Suspension as adjunctive therapy for the treatment of parti...
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FDA Approves Vaxchora
The U.S. Food and Drug Administration today approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults 18 through 64 years of age traveling to chol...
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FDA Approves Xiidra
The U.S. Food and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease, on Monday, July 11, 2016. Xiidra...
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FDA Approves Differin Gel 0.1% for Over-the-Counter Use to Treat Acne
The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is ...
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Portola Pharmaceuticals Receives Complete Response Letter from FDA for Biologics License Application for AndexXa (andexanet alfa)
Portola Pharmaceuticals Inc.® (NASDAQ:PTLA) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Bi...
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FDA Approves Yosprala
FDA Approves Yosprala (aspirin and omeprazole) for Secondary Prevention of Cardiovascular Disease in Patients at Risk for Aspirin-Associated Gastric Ulcers
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FDA Approves Cuvitru
Shire Announces FDA Approval of Cuvitru [immune globulin subcutaneous (human)] for Primary Immunodeficiency
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Hyoscyamine sulfate 0.125mg by Virtus Pharmaceuticals: Recall - Superpotent and Subpotent Test Results
ISSUE: Virtus Pharmaceuticals Opco II, LLC (Virtus) is voluntarily recalling seven batches of Hyoscyamine sulfate (0.125mg) to the consumer level which include the tablet, subling...
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FDA Accepts the BLA for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma for Priority Review
EMD Serono Inc., the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. (NYSE: PFE (link is external)) today announced that the US ...
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