Perrigo has achieved a major milestone in women’s healthcare with the FDA approving Opill as an over-the-counter oral contraceptive. Opill is the first birth control pill available without a prescription in the US, revolutionizing access to contraception. Perrigo’s commitment to enhancing lives is evident in this impactful solution for women’s health. Opill has a long history of safe and effective use, supported…
Pharma company Fresenius Kabi has announced the launch of Ganirelix Acetate Injection, a generic fertility drug. The medication is now available for immediate purchase from Fresenius Kabi in the form of 250 mcg/0.5 mL prefilled syringes. Ganirelix Acetate Injection is primarily used to inhibit premature surges in luteinizing hormone (LH), a chemical that triggers reproductive processes like ovulation. It is specifically designed…
Medicines360, a San Francisco-based nonprofit organization, has achieved a significant milestone with the recent FDA approval of its supplemental New Drug Application (sNDA) for LILETTA. This approval allows LILETTA (levonorgestrel-releasing intrauterine system) 52 mg to be utilized as a treatment option for Heavy Menstrual Bleeding (HMB) for up to five years in women who opt for intrauterine contraception. Extensive research has demonstrated…
Freya Biosciences, a biotech company specializing in women’s health, has released positive topline results from the Phase 1 clinical trial of FB101, their vaginal microbial immunotherapeutic. The trial focused on addressing asymptomatic vaginal dysbiosis, a common condition in women undergoing infertility treatments. The findings show promise for improving fertility outcomes, particularly in in vitro fertilization (IVF) procedures. Freya Biosciences, headquartered in Copenhagen,…
Nipocalimab, an investigational treatment developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, has demonstrated promising outcomes in pregnant individuals at high risk of early-onset severe haemolytic disease of the foetus and newborn (HDFN). HDFN is a rare blood disorder which occurs in between 3 and 80 out of every 100.000 pregnancies and can be fatal. The Phase 2 clinical trial…
Vistagen, a biopharma company focused on developing treatments for anxiety, depression, and other central nervous system disorders, has announced positive results from an exploratory Phase 2A study of PH80 in women diagnosed with menopausal hot flashes. The study, which involved 36 participants, demonstrated statistically significant efficacy of PH80 nasal spray compared to a placebo. The Phase 2A clinical study was designed to…
In a breakthrough development for men’s sexual health, the US Food and Drug Administration (FDA) has granted over-the-counter (OTC) marketing authorization to Futura Medical’s topical gel, MED3000, a first-of-its-kind treatment for erectile dysfunction (ED). The quick-acting gel formulation, delivered through Futura’s proprietary DermaSys drug delivery technology, starts working within 10 minutes of application, promising an innovative solution for millions of men globally.…
Mithra Pharmaceuticals and BCI Pharma, have announced promising preliminary data from their CSF-1R inhibitor program. The research indicates that Mithra’s lead CSF-1R inhibitor compound displays significant anti-tumor activity, and may work synergistically with PD-1 cancer immune checkpoint inhibitors. The CSF-1R inhibitor demonstrated its efficacy in three preclinical cancer models, modulating the tumor microenvironment and potentially reducing tumor growth by up to 59%.…
