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…
FDA approval brought first gene therapy to the U.S.
On Aug. 30, 2017, the U.S. Food and Drug Administration (FDA) approved Kymriah (tisagenlecleucel) for certain pediatric and…
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…
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…
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 (FDA) unveiled a strategic plan to completely eliminate…
The FDA approved Endari developed by Dr Yutaka Niihara at LA Biomed
On Jun. 7, 2017 the FDA approved Endari (L-glutamine oral powder) for patients age five years and older…
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)…
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…
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…
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…
Biotechnology | Chemical | Disease | FDA | Life Science News | 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…
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…
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….
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 13ï¾® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) received FDA…
FDA approved revisions in package insert for YF-Vax reflected changes to International Health Regulations and recommendations
On Jun. 15, 2016, the FDA approved revisions in the package insert for YF-Vax to reflect changes to…
FDA approved Vaxchora for the prevention of cholera
On Jun. 10, 2016, the U.S. Food and Drug Administration (FDA) approved Vaxchora, a vaccine for the prevention…
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…
FDA approved Hiberix for full Hib vaccineï¾ series
On Apr. 29, 2016, GlaxoSmithKline Biologicals in Research Triangle Park, North Carolina, received U.S. Food and Drug Administration…
FDA approved changes to vaccine administrationï¾ schedule for Trumenba vaccine
On Jun. 14, 2016, the FDA approved changes to vaccine administrationï¾ schedule for Trumenba vaccine produced by Wyeth Pharmaceuticals,…
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…
FDA expanded Gardasil 9 licensure to include males age 16ï¾–26 years
On Dec. 14, 2015, the FDA expanded Merck’s Gardasil 9 licensure to include males age 16ï¾–26 years. The…
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…
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 Fluadâ„¢ (Influenza…
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…
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…
Biotechnology | CDC | FDA | Life Science News | NIH | Non-Profit Research | Pharmaceutical | Vaccine
CDC published updated ACIP recommendations regarding the intervals between PCV13 and PPSV23 vaccines
On Sept. 4, 2015, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices…
FDA approved injectable drug to eliminate double chin
On Apr. 29, 2015, the U.S. Food and Drug Administration (FDA) announced it had approved Kybella, an injection…
FDA approved the Quadracelï¾ DTaP+IPV ï¾ vaccine for use in children age 4-6 years
On Mar. 24, 2015, the U.S. Food and Drug Administration (FDA) approved Sanofi’s Quadracel, a newï¾ combinationï¾ DTaP+IPVï¾ vaccine for…
The first biosimilar Zarxio (Filgrastim-sndz) was approved by the FDA
On Mar. 6, 2015, the FDA approved filgrastim-sndz (Zarxio, Sandoz, Inc.), the first biosimilar product available in the…
FDA approved the use of Bexsero, the second vaccine licensed in the U.S. to prevent serogroup B meningococcal disease
On Jan. 23, 2015, Novartis announced the US Food and Drug Administration (FDA) had granted accelerated approval of…