Tag: Submits

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Genentech Submits Supplemental Biologics License Application to the FDA for Tecentriq in Combination With Avastin for the Most Common Form of Liver Cancer

Newsemia
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the completion of a supplemental Biologics License...
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Aerie Pharmaceuticals Submits Marketing Authorisation Application for Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% in Europe

Newsemia
DURHAM, N.C.–(BUSINESS WIRE)–Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients...
Biology

Personalized Stem Cells, Inc. Submits Investigational New Drug (IND) Application for the Treatment of Osteoarthritis with Stem Cells

Newsemia
POWAY, Calif. (PRWEB) June 18, 2019 Personalized Stem Cells, Inc (“PSC�), a human adipose-derived stem cell company, has submitted an Investigational New Drug (IND) application...
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Genentech Submits Supplemental Biologics License Application to FDA for Kadcyla for Adjuvant Treatment of People With HER2-Positive Early Breast Cancer With Residual Disease After Neoadjuvant Treatment

Newsemia
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced completing the submission of a supplemental Biologics...
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Zymeworks Submits Investigational New Drug (IND) Application for ZW49 and Presents IND-Enabling Studies at the San Antonio Breast Cancer Symposium

Newsemia
VANCOUVER, Canada–(BUSINESS WIRE)–Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, presented IND-enabling data for ZW49, a novel biparatopic HER2-targeted ADC, at the...

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