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FDA Approves Breast Cancer Treatment americanpharmaceuticalreview
July 29, 2021
The FDA approved pembrolizumab (Keytruda, Merck) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
FDA Grants Pancreatic Cancer Treatment Orphan Drug Designation americanpharmaceuticalreview
July 29, 2021
XOMA Corporation announced NIS793 in combination with standard of care chemotherapy has been granted Orphan Drug Designation in pancreatic cancer by the U.S. FDA.
Johnson & Johnson Statement on U.S. FDA Approval of Shelf Life Extension for Company’s COVID-19 Vaccine drugs
July 29, 2021
We are pleased to confirm the U.S. Food & Drug Administration (FDA) has extended the shelf life for the Johnson & Johnson single-shot COVID-19 vaccine to six months. The decision is based on data from ongoing stability assessment studies.
Satsuma Pharmaceuticals Announces First Subject Randomized in SUMMIT™, a Phase 3 Efficacy Trial of STS101 for the Acute Treatment of Migraine drugs
July 29, 2021
Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA) today announced randomization of the first subject in its SUMMIT Phase 3 efficacy trial of STS101 for the acute treatment of migraine.
Ardelyx Provides Regulatory Update on New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis drugs
July 29, 2021
Ardelyx today announced that it received a letter from the U.S. Food and Drug Administration (the "FDA") on July 13, 2021, stating that, as part of its ongoing review of the company's NDA for the control of serum phosphorus in adult patients with CKD.
FDA Approves Keytruda (pembrolizumab) Plus Lenvima (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma drugs
July 29, 2021
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the combination of Keytruda, Merck’s anti-PD-1 therapy, plus Lenvima.
Dalvance (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients drugs
July 29, 2021
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved Dalvance® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth.
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.

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