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Mycovia Pharmaceuticals Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis drugs
July 29, 2021
Mycovia Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for oteseconazole, an oral antifungal product for the treatment of recurrent vulvovaginal candidiasis (RVVC).
FDA grants interchangeable status to Viatris' biosimilar insulin Semglee firstwordpharma
July 29, 2021
The FDA announced Wednesday that Viatris' biosimilar insulin product Semglee (insulin glargine-yfgn) may now be substituted for its reference product, Sanofi's long-acting insulin analogue Lantus (insulin glargine), without the intervention of a prescribe
Rhythm Pharmaceuticals Announces Collaborative Research Agreement with Clinical Registry Investigating Bardet-Biedl Syndrome firstwordpharma
July 29, 2021
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company committed to transforming the care of people living with rare genetic diseases of obesity, today announced a collaborative research agreement with the CRIBBS.
US needs to look differently at public health preparedness, says former FDA commissioner Gottlieb cphi-online
July 29, 2021
Speaking at CPhI North America, Dr Scott Gottlieb shares insights into how the US should prepare for future pandemics by building out vaccine capacities
FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes fda.gov
July 29, 2021
Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus.
Regulators call for clinical research to include pregnant and breastfeeding women europeanpharmaceuticalreview
July 28, 2021
The FDA and other global regulators are co-operating to address inadequacies in clinical research that leave pregnant and breastfeeding women lacking data on which to base their medical decisions.
US FDA approves Shingrix to prevent shingles in immuno-compromised adults expresspharma
July 28, 2021
Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine, given intramuscularly in two doses, was initially approved by FDA in 2017 for the prevention of shingles in adults 50 years of age or older.
FDA Accepts Braeburn’s New Drug Application Resubmission for Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder drugs
July 28, 2021
Braeburn announces that the New Drug Application (NDA) for Brixadi (buprenorphine) extended-release weekly and monthly injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was accepted by the FDA.
Iterum Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Oral Sulopenem drugs
July 28, 2021
Iterum Therapeutics plc (Nasdaq: ITRM) today announced that it received a Complete Response Letter (CRL) from the FDA for its NDA for sulopenem etzadroxil/probenecid (oral sulopenem) on July 23, 2021.
FDA Approves Twyneo (tretinoin and benzoyl peroxide) for the Treatment of Acne Vulgaris drugs
July 28, 2021
Sol-Gel Technologies, Ltd. today announced that FDA has approved its first proprietary drug product, Twyneo cream, 0.1%/3%, indicated for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older.

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