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EU backs second biosimilar copy of Humira

European regulators recommended approval of a second copy of AbbVie’s rheumatoid arthritis drug Humira, the world’s top-selling medicine.

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Germany’s Merck gets EU backing for oral MS drug

Merck KGaA won a key recommendation to become an entrant to the oral MS drug market in Europe, six years after its first attempt to launch the cladribine pill failed.

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FDA Approves Rituxan Hycela for Subcutaneous Injection in Certain Blood Cancers

The U.S. FDA approved Genentech’s Rituxan Hycela (rituximab and hyaluronidase human) for subcutaneous injection for the treatment of adults with certain blood cancers.

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FDA Slaps Hold on IND for Vadastuximab Talirine

The U.S. FDA placed a hold on Seattle Genetics’ Investigational New Drug Application for vadastuximab talirine.

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Kamada Withdraws MAA For Inhaled Alpha-1 Antitrypsin

Kamada Ltd. withdrew the Marketing Authorization Application (MAA) for its proprietary inhaled Alpha-1 Antitrypsin therapy for the treatment of Alpha-1 Antitrypsin Deficiency with the EMA.

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U.S. FDA moves to prevent Pharma from ‘gaming’ generic drug system

The U.S. Food and Drug Administration moved to prevent pharmaceutical companies from “gaming” the system to block or delay entry of generic rivals.

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FDA Approves Cotempla XR-ODT For ADHD

The FDA approved Neos’ Cotempla XR-ODT, the first methylphenidate extended-release orally disintegrating tablet for treating ADHD in patients 6 to 17 years old.

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FDA approves antibiotic for serious skin infections

The U.S. Food and Drug Administration approved a new treatment for patients with acute bacterial skin infections, made by privately held Melinta Therapeutics.

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Adamis wins U.S. approval to sell EpiPen rival

Adamis Pharmaceuticals Corp. received U.S. approval for its emergency epinephrine syringes to treat severe allergic reactions that the company intends to be a lower cost rival to Mylan NV’s widely used EpiPen, sending its shares up more than 50 percent.

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FDA delays rolling out new nutrition facts label

The U.S. Food and Drug Administration delayed indefinitely implementation of a new nutrition facts label that would enlarge calorie counts, itemize added sugar and bring serving sizes in line with actual average portions.

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FDA rejects Coherus’ biosimilar for Amgen’s Neulasta

Coherus BioSciences Inc. said the U.S. FDA denied the approval of its biosimilar for Amgen Inc.’s blockbuster treatment Neulasta, which fights infections in cancer patients.

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Annual Report: State of the Bio Industry

R&D success and M&A activity loom as large swing factors for the bio sector in 2017 with the regulatory arena potentially at its most amenable for years.

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FDA approves new use for Edwards’ Sapien 3 heart valve

FDA approved Edwards Lifesciences’ Sapien 3 artificial heart valve for high-risk patients whose previously implanted heart valves are failing, a procedure designed to avoid repeat open heart surgery.

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2-Drug HIV Treatment Filed for U.S., EU Approval

ViiV Healthcare made regulatory submissions to the EMA and the U.S. FDA for a single-tablet, two-drug regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen).

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EU Approves Biogen’s Spinraza for SMA

Biogen Inc.’s Spinraza secured European Union approval to treat spinal muscular atrophy (SMA), a leading genetic cause of death in infants.

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EU Approves Brineura for CLN2 Disease

The European Commission granted marketing authorization for BioMarin Pharmaceutical’s Brineura for the treatment of tripeptidyl peptidase 1 (TPP1) deficiency.

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Nicox Receives FDA Approval Of Zerviate 0.24%

The U.S. FDA approved the New Drug Application for Nicox S.A.’s Zerviate, the first topical ocular formulation of the well-known antihistamine cetirizine.

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Merck Receives FDA Approval of Isentress HD

Merck announced that the U.S. FDA approved Isentress HD, a new 1,200 mg once-daily dose of the company’s integrase inhibitor Isentress (raltegravir).

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Kite NHL Drug Receives FDA Priority Review

Kite Pharma announced that the U.S. FDA accepted for priority review the BLA for axicabtagene ciloleucel for refractory aggressive non-Hodgkin lymphoma (NHL).

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Pfizer Biosimilar Recommended for U.S. Approval

The U.S. FDA Oncologic Drugs Advisory Committee recommended approval of Pfizer’s proposed epoetin alfa biosimilar across all indications.

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