FDA published guidance to industry known as the “red book”
On Jan. 31, 2018, the FDA published the first Red Book, the successor to 1949 “black book,” officially…
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FDA approved expanded pediatric age indication for Fluarix Quadrivalent influenza vaccine
On Jan. 11, 2018, the U.S. Food and Drug Administration (FDA) approved an expanded indication for the four-strain…
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Biotechnology | CDC | Diagnostics | FDA | Infectious Disease | Influenza | U.S. Congress | Vaccine | Veterinary
Experts decried lack of flu pandemic readiness, commitment
On Jan. 9, 2018, armed with 1940s-vintage flu vaccine technology and supported by only anemic funding for developing…
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Ozempic (semaglutide) was approved in the U.S.
On Dec. 5, 2017, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) had approved Ozempic…
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Biotechnology | Disease | FDA | Oncology | Therapeutics
FDA approved first biosimilar for the treatment of certain breast and stomach cancers
On Dec. 1, 2017, the U.S. Food and Drug Administration (FDA) approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar…
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Disease | FDA | Therapeutics
Genentech drug Hemlibra (emicizumab-kxwh) was approved
On Nov. 16, 2017, the the U.S. Food and Drug Administration (FDA) approved the Genentech drug Hemlibra (emicizumab-kxwh)…
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FDA licensed Heplisav-B, the new hepatitis B vaccine from Dynavax, for use in adults age 18 and older
On Nov. 9, 2017, Dynavax Technologies announced that the U.S. Food and Drug Administration (FDA) had approved HEPLISAV-B…
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FDA licensed Shingrix, the new shingles vaccine from GlaxoSmithKline, for use in adults age 50 and older
On Oct. 23, 2017, GlaxoSmithKline announced the U.S. Food and Drug Administration (FDA) had approved Shingrix (Zoster Vaccine…
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Biotechnology | FDA | Oncology | Therapeutics
FDA approves personalized cellular therapy for advanced leukemia developed at Penn and CHOP
On Aug. 30, 2017, the U.S. Food and Drug Administration (FDA) approved a personalized cellular therapy developed by…
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Biotechnology | Disease | FDA | Neurology | Therapeutics
Adamas announced FDA approval of GOCOVRI as first and only medication fortreatment of Dyskinesia in Parkinson’s disease Patients
On Aug. 24, 2017, Adamas announced U.S. Food and Drug Administration (FDA) approval of GOCOVRI as First and…
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Seqirus announced major advances in pandemic preparedness
On Aug. 7, 2017, Seqirus announced that the accelerated development of cell-based manufacturing technology at its state-of-the-art manufacturing…
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Biotechnology | FDA | Therapeutics | Vaccine
The FDA unveiled a strategic plan to completely eliminate the agency’s existing orphan designation backlog
On Jun. 29, 2017, the U.S. Food and Drug Administration unveiled a strategic plan to completely eliminate the…
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The FDA approved Endari for sickle cell disease
On Jun. 7, 2017 the U.S. Food and Drug Administration (FDA) approved Endari (L-glutamine oral powder) for patients…
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Genentech drug Ocrevus (ocrelizumab) was approved
On Mar. 28, 2017, Genentech drug Ocrevus (ocrelizumab) was approved by the U.S. Food and Drug Administration (FDA)…
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Francis Collins was reappointed director of the U.S. National Institutes of Health
On Jan. 19, 2017, Francis S. Collins, M.D., Ph.D. was reappointed Director of the National Institutes of Health…
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First drug approved by the FDA for treatment of canine lymphoma
On Jan. 3, 2017, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) announced the conditional…
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FDA approved extending the age range for use of FluLaval Quadrivalent to include children 6 to 35 months of age
On Nov. 18, 2016, the U.S. Food and Drug Administration (FDA) approved extending the age range for use…
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Roswell Park study brought Cuban lung cancer vaccine to U.S. Patients
On Oct. 27, 2016, Roswell Park Cancer Institute announced it had received authorization from the U.S. Food and…
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Biotechnology | Chemistry | Disease | FDA | Oncology | Therapeutics
Genentech drug Tecentriq (atezolizumab) was approved
On Oct. 18, 2016, the U.S. Food and Drug Administration (FDA) approved TECENTRIQ® (atezolizumab) for the treatment of…
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Seqirus received FDA approval for AFLURIA® QUADRIVALENT (Influenza Vaccine) for people 18 years of age and older
On Aug. 29, 2016, Seqirus announced that the U.S. Food and Drug Administration (FDA) had approved AFLURIA® QUADRIVALENT…
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InBios received FDA EUA for its ZIKV Detect IgM Capture ELISA diagnostic test for antibodies in human serum
On Aug. 19, 2016, InBios announced that it had received an Emergency Use Authorization (EUA) from the U.S….
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FDA extended the age indication for PCV13 (Prevnar 13) to include adults age 18 through 49 years
On Jul. 12, 2016, Pfizer announced that Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) received U.S….
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Biotechnology | FDA | Vaccine
FDA approved Vaxchora for the prevention of cholera
On Jun. 12, 2016, the U.S. Food and Drug Administration (FDA) approved Vaxchora, a vaccine for the prevention…
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FDA revised the Nutrition and Supplement Facts Labels
On May 27, 2016, the Food and Drug Administration (FDA) announced it had amended its labeling regulations for…
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Biotechnology | FDA | Oncology | Therapeutics
Genentech drug Venclexta (venetoclax) was approved
On Apr. 11, 2016, the U.S. Food and Drug Administration (FDA) announced that it had granted accelerated approval…
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FDA expanded Gardasil 9 licensure to include males age 16-26 years
On Dec. 14, 2015, the U.S. Food and Drug Administration (FDA) announced it had expanded Merck’s Gardasil 9…
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Biotechnology | Diagnostics | FDA | Oncology | Therapeutics
Genentech drug Alecensa (alectinib) was approved by FDA
On Dec. 11, 2015, Genentech announced that it’s drug Alecensa (alectinib) was approved by the U.S. Food and…
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FDA approved new injectable influenza vaccine, Fluad, for use in people age 65 years and older
On Nov. 25, 2015, Seqirus announced that the U.S. Food and Drug Administration (FDA) had approved Fluad™ (Influenza…
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The FDA approved AquaBounty Technologies’ application to sell the AquAdvantage genetically engineered salmon
On Nov. 19, 2015, AquaBounty Technologies announced the U.S. Food and Drug Administration (FDA) had approved the Company’s…
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Genentech drug Cotellic (cobimetinib) was approved
On Nov. 10, 2015, Genentech announed that its drug Cotellic (cobimetinib) was approved by the U.S. Food and…
