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Shires Takhzyro Approved for Hereditary Angioedema

[ Price : $8.95]

FDA approves a Shire BLA for Takhzyro (lanadelumab-flyo) injection for preventing hereditary angioedema attacks in patients 12 yea...

FDA Approves Imbruvica and Rituximab for Rare Disease

[ Price : $8.95]

FDA approves Janssen Biotech and Pharmacyclics Imbruvica (ibrutinib) in combination with Genentechs rituximab for treating Waldens...

CathWorks 510(k) for Fractional Flow Reserve Device

[ Price : $8.95]

CathWorks files a 510(k) for its CathWorks FFRangio System, a fractional flow reserve device that is intended to deliver objective...

Warning Letter Sent to Zimmer Biomet Subsidiary

[ Price : $8.95]

FDA 8/24 sends a Warning Letter to a Zimmer Biomet subsidiarys manufacturing facility in Warsaw, IN over GMP issues documented in ...

Pfizer Petitions FDA for Guidance on Biosimilar Communications

[ Price : $8.95]

Pfizer petitions FDA to issue a guidance document to clarify appropriate sponsor communications about the nature and properties of...

Pharmaceutical Quality Site Visit Program

[ Price : $8.95]

Federal Register notice: CDER announces the Fiscal Year 2019 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learni...

Plasma Lyte Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Plasma Lyte M And Dextrose 5% and Plasma Lyte and Dextrose 5% were not withdrawn for...

Guide on Hematologic Malignancy and Oncologic Drug Trials

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Hematologic Malignancy and Oncologic Disease: Consideration...

Appeals Court Reverses GSK $3 Million Liability Suit

[ Price : $8.95]

The U.S. Court of Appeals for the Seventh Circuit reverses a lower court decision and $3 million verdict in a product liability th...

Ortho Dermatologics Tretinoin Lotion Approved

[ Price : $8.95]

FDA approves an Ortho Dermatologics NDA for Altreno (tretinoin 0.05%) lotion, indicated for the topical treatment of acne vulgaris...