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Kymriah wins speedy reviews in U.S., Europe

Novartis was granted fast-track reviews of its cell therapy Kymriah for blood cancers in the United States and Europe.

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Imprimis receives FDA warning

The U.S. FDA issued a warning letter to Imprimis Pharmaceuticals Inc. accusing it of making false or misleading claims that its compounded eye medications had the agency’s approval.

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FDA expects IV fluid shortage to improve in coming weeks, months

The U.S. FDA expects a shortage of intravenous saline fluids for hospitals due to damage to key manufacturing facilities in Puerto Rico to improve over the coming weeks and months.

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FDA to speed review of military medical products

The U.S. FDA and Department of Defense launched a program to speed up the development of drugs that could be used by military personnel.

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FDA approves new indication for Gilotrif

The U.S. FDA approved a supplemental NDA for Gilotrif (afatinib) for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor receptor mutations as detected by an FDA-approved test.

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U.S. FDA Approves Teva’s Trisenox

Trisenox (arsenic trioxide) injection was approved in combination with tretinoin for treating adults with newly diagnosed low-risk acute promyelocytic leukemia.

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Shire granted EU approval for Adynovi

The European Commission granted Marketing Authorization for Shire’s ADYNOVI [Antihemophilic Factor (Recombinant), PEGylated], for on-demand and prophylactic use in patients 12 years and older living with hemophilia A.

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FDA approves expanded use of AstraZeneca drug

The U.S. Food and Drug Administration approved expanded use of AstraZeneca Plc’s cancer drug Lynparza.

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GSK receives FDA approval for expanded indication for Fludriarix Quavalent for persons 6 months and older

GSK announced it received approval from the U.S. FDA’s Center for Biologics Evaluation and Research expanding the indication for FLUARIX QUADRIVALENT (Influenza Vaccine) to include use in persons 6 months and older.

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Roche MS medicine Ocrevus wins EU approval

The European Union approved Roche’s multiple sclerosis medicine Ocrevus, one of the Swiss company’s key new drugs.

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FDA warns BD of significant violations

The U.S. Food and Drug Administration issued a warning letter to Becton Dickinson (BD) & Company that cited several violations of federal law.

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FDA Slaps Breakthrough Tag on Combo RCC Drug

Merck & Co. and development partner Eisai Co. snagged Breakthrough Therapy Designation from the FDA for a combo renal cell carcinoma (RCC) treatment.

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FDA expands use of Amgen’s blockbuster drug

Amgen Inc. said the U.S. FDA approved its drug Xgeva to prevent fractures in patients with multiple myeloma.

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Takeda Takes Out TiGenix in $630 Million Deal

Shares of Belgium-based TiGenix NV shot up after Japan’s Takeda Pharmaceutical opted to acquire the company for $630 million.

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Novartis’ Promacta receives FDA breakthrough designation for new indication

Promacta received breakthrough therapy designation from the FDA for first-line treatment of SAA.

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Novartis breast cancer therapy gets FDA breakthrough designation

Novartis’ Kisqali (ribociclib) won U.S. Food and Drug Administration breakthrough therapy designation for treating some breast cancer patients.

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FDA Accepts Supplemental Biologics License Application and Grants Priority Review for Adcetris in Frontline Advanced Hodgkin Lymphoma

Normal immune cells that live near milk ducts in healthy breast tissue may play a key role in helping early breast cancer cells leave the breast for other parts of the body, researchers say.

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New drug approvals hit 21-year high in 2017

U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light — more than double the previous year — while the figure also rose in the EU.

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Mylan Wins FDA Approval of First Generic for Estrace Cream

The FDA approved Mylan’s Estradiol Vaginal Cream USP 0.01%, the first generic version of Allergan’s Estrace.

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Fresenius Allegedly Ignored Hundreds of Bad Quality Tests at Plant in India

The U.S. Food and Drug Administration issued a warning letter to Fresenius Kabi AG of Germany for its plant in India.

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