Drug Pipeline News
Whooping cough vaccine approved for use during third trimester
October 07, 2022
The US Food & Drug Administration approved tetanus toxoid, reduced diptheria toxoid and acellular pertussis vaccine, adsorbed [Tdap] (Boostrix, GSK) today for immunization during the third trimester of pregnancy to prevent pertussis—or whooping cough—in infants under 2 months of age.
The future of ibrexafungerp for prevention of recurrent yeast infections
September 09, 2022
Nkechi Azie, MD, MBA, FIDSA, vice president of clinical development and medical affairs at SCYNEXIS, discusses the potential FDA approval of ibrexafungerp (Brexafemme; SCYNEXIS) for the prevention of recurrent vulvovaginal candidiasis.
FDA expands approval of Mirena for up to 8 years
August 22, 2022
After a recent FDA approval, Mirena can be used to prevent pregnancy for up to 8 years.
FDA grants emergency use of Novavax COVID-19 vaccine, adjuvanted in patients 12 years and older
August 22, 2022
Novavax joins the growing list of COVID-19 vaccines including vaccines from Pfizer-BioNTech, Moderna, and Johnson & Johnson’s Janssen
FDA approves generic cetrorelix acetate injection
August 19, 2022
The FDA has approved cetrorelix acetate for injection, a generic version of Cetrotide, for the inhibition of premature luteinizing hormone surges in women undergoing controlled ovarian stimulation.
Vivjoa approved for recurrent vulvovaginal candidiasis
August 08, 2022
Oteseconazole is a treatment option for those living with a previously unmet medical need.
FDA approves Myfembree for endometriosis pain
August 05, 2022
Myovant Sciences and Pfizer announces the US Food and Drug Administration has approved Myfembree (relugolix combination tablets) for the once-daily treatment of moderate-to-severe endometriosis-associated pain.
FDA grants ibrexafungerp sNDA priority review for RVVC
August 02, 2022
If approved, ibrexafungerp would be the first and only approved therapy for both the treatment of vulvovaginal candidiasis (VVC) and the prevention of recurrent vulvovaginal candidiasis (RVVC).
ObsEva drops linzagolix, focuses on prospects for preterm labor, IVF
July 28, 2022
ObsEva plans to drop linzagolix, its leading candidate for the treatment of uterine fibroids, following concerns raised by the FDA.
Fezolinetant making waves for VMS
July 26, 2022
Genevieve Neal-Perry, MD, PhD, sits down with Contemporary OB/GYN to discuss positive data from a recent phase 3 study evaluating fezolinetant (Astellas) for vasomotor symptoms (VMS).