The FDA’s “Breakthrough Therapy Designation” was created
On Jul. 9, 2012, the FDA created the “Breakthrough Therapy Designation” that expedites development and review of drugs…
Biotechnology | Disease | FDA | Life Science News | Vaccine
FDA approved HibMenCY vaccine for infants
On Jun. 24, 2012, the U.S. Food and Drug Administration (FDA) announced it had approved HibMenCY (Menhibrix, GlaxoSmithKline),…
Genentech drug Perjeta (pertuzumab) was approved
On Jun. 8, 2012, the U.S. Food and Drug Administration (FDA) announced that Genentech’s drug Perjeta (pertuzumab) was…
FDA expanded licensure of PCV13 to include adults ages 50 years and older
On Jun. 7, 2012, the FDA expanded licensure of PCV13 for prevention of pneumococcal disease to include adults…
FDA approved orphan drug Elelyso to treat a form of Gaucher disease
On May 1, 2012, the U.S. Food and Drug Administration (FDA) approved new orphan drug Elelyso to treat…
The FDA approved Korlym for patients with endogenous Cushing’s syndrome
On Feb. 17, 2012, the FDA announced Korlym (mifepristone) was approved to control high blood sugar levels (hyperglycemia)…
The FDA approved Gleevec for Five Rare, Life-Threatening Disorders
On Jan. 31, 2012, the U.S. Food and Drug Administration (FDA) granted Gleevec (imatinib) regular approval for use…
The FDA approved KALYDECO (ivacaftor) a University of Washington-tested drug to treat the genetic mechanism of cystic fibrosis
On Jan. 31, 2012, the FDA approved a KALYDECO (ivacaftor), University of Washington-tested drug to treat the genetic…
The U.S. FDA approved Erivedge (vismodegib) capsule, the first medicine for adults with advanced basal cell carcinoma
On Jan. 30, 2012, the U.S. Food and Drug Administration (FDA) approved Genentech’s Erivedge (vismodegib) capsule, the first…
FDA expanded use of Prevnar 13 vaccine to include people ages 50 and older
On Dec. 30, 2011, Pfizer announced that the U.S. Food and Drug Administration (FDA) had granted approval of…
Addition of history of intussusception as a contraindication for rotavirus vaccination
On Oct. 21, 2011, the Food and Drug Administration (FDA) announced it had approved revised prescribing information and…
Disease | FDA | Life Science News | Oncology
The FDA approved Seattle Genetics’ Adcetris (brentuximab vedotin)
On Aug. 19, 2011, the U.S. Food and Drug Administration (FDA) approved Seattle Genetics’ Adcetris (brentuximab vedotin), making…
Genentech medicine approved for certain type of melanoma
On Aug. 17, 2011, Genentech announced that Elborafﾮ (vemurafenib) was approved by the FDA for the treatment of…
Genentech drug Zelboraf (vemurafenib) was approved
On Aug. 16, 2011, the U.S. Food and Drug Administration (FDA) approved vemurafenib tablets (Zelboraf, Hoffmann-LaRoche Inc.) for…
FDA approved Boostrix to prevent tetanus, diphtheria, and pertussis in older people
On Jul. 8, 2011, the FDA approved Boostrix (Tdap, GlaxoSmithKline) to prevent tetanus, diphtheria, and pertussis in older…
FDA approved the first vaccine to prevent meningococcal disease in infants and toddlers
On Apr. 22, 2011, The U.S. Food and Drug Administration (FDA) approved the use of Menactra in children…
Zostavax was approved by the FDA to prevent shingles in individuals 50 years of age and older
On Mar. 24, 2011, Zostavax, manufactured by Merck of Whitehouse Station, New Jersey, was approved by the U.S….
Gilead Sciences acquired Calistoga Pharmaceuticals for $375 Million
On Feb. 22, 2011, Foster City, Calif-based Gilead Sciences and Calistoga Pharmaceuticals announced Gilead’s acquisition of Calistoga for…
FDA approved Gardasil HPV vaccine to include the indication for the prevention of anal cancer
On Dec. 22, 2010, the FDA approved Gardasil HPV vaccine to include the indication for the prevention of…
PROVENGE was approved by the FDA
On Apr. 29, 2010, the FDA approved sipuleucel-T (PROVENGE), made by the Dendreon Corp., an autologous cellular immunotherapy…
FDA recommended physicians suspend use of GSK’s Rotarix rotavirus vaccine due to porcine circovirus 1 contamination
On Mar. 23, 2010, the U.S. Food and Drug Administration (FDA) recommended that physicians temporarily suspend use of…
FDA approved licensure of Pneumococcal 13-valent conjugate vaccine
On Feb. 24, 2010, a 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals, a subsidiary of Pfizer])…
FDA approved licensure of Menveo (Novartis), meningococcal conjugate vaccine
On Feb. 19, 2010, the U.S. Food and Drug Administration (FDA) announced it had licensed a quadrivalent meningococcal…
FDA Approves Tocilizumab for Treatment of Rheumatoid Arthritis
On Jan. 11, 2010, the U.S. Food and Drug Administration (FDA) approved Genentech’s tocilizumab (Actemra) for the treatment…
FDA approved Cervarix, GlaxoSmithKline’s cervical cancer vaccine
On Oct. 16, 2009, GlaxoSmithKline announced the U.S. Food and Drug Administration (FDA) had approved Cervarix [Human papillomavirus…
FDA approved new indication for gardasil to prevent genital warts in men and boys
On Oct. 16, 2009, the U.S. Food and Drug Administration (FDA) approved new indication for gardasil to prevent…
FDA approved four vaccines against the 2009 H1N1 influenza virus
On Sept. 15, 2009, the U.S. Food and Drug Administration (FDA) approved four Influenza A (H1N1) 2009 Monovalent…
Vaccine Court ruled that MMR vaccine does not cause autism
On Feb. 12, 2009, the Vaccine Court ruled that MMR vaccine, when administered with thimerosal-containing vaccines, does not…
FDA approved first genetically engineered animal for production of a recombinant form of human antithrombin
On Feb. 6, 2009, the U.S. Food and Drug Administration (FDA) approved the first genetically engineered animal for…
FDA approved changes in the schedule for administering anthrax vaccine
On Dec. 19, 2008, the Food and Drug Administration (FDA) approved changes in the schedule for administering anthrax…