Pfizer Inc. (NYSE: PFE)  announced the U.S. Food and Drug Administration (FDA)  approval of Zavzpret (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults. In its pivotal Phase 3 study, Zavzpret was statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptom at two hours post-dose. The pivotal study also demonstrated pain relief as early as 15 minutes in a prespecified secondary endpoint ve ..read more

In continuation of my update on omaveloxolone Reata Pharmaceuticals, Inc. (Nasdaq: RETA) announced   the U.S. Food and Drug Administration (“FDA”) approval of  Skyclarys™ (omaveloxolone) for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older. With this approval, the FDA granted a rare pediatric disease priority review voucher. "The approval of Skyclarys, the first therapy specifically indicated for the treatment of Friedreich’s ataxia, is an important milestone for patients affected by this disease as well as their families and careg ..read more

In continuation of my update on rezafungin Cidara Therapeutics, Inc.   and Melinta Therapeutics, LLC  announced   the U.S. Food and Drug Administration (FDA) approval of  Rezzayo (rezafungin for injection) for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. Rezzayo is the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade. “The FDA approval of Rezzayo represents a significant milestone for Cidara, and for patients confronted w ..read more

TheracosBio  announced  the U.S. Food and Drug Administration (FDA)   approval of  Brenzavvy (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor. Brenzavvy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Brenzavvy is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Brenzavvy is contraindicated in patients who are hypersensitive to bexagliflozin or any tablet ingredient and is not indicated for the treatment of type 2 diab ..read more

The Menarini Group (“Menarini”), a leading Italian pharmaceutical and diagnostics company, announced  the U.S. Food and Drug Administration (FDA)   approval of  Orserdu for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Stemline Therapeutics (“Stemline”), a wholly-owned subsidiary of the Menarini Group, headquartered in New York and focused on bringing transformational oncology treatments for cancer patients, will ..read more

GSK plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA)  approval of  Jesduvroq (daprodustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the once-a-day treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. Jesduvroq is the first innovative medicine for anemia treatment in over 30 years and the only HIF-PHI approved in the US, providing a new oral, convenient option for patients in the US with anemia of CKD on dialysis. The FDA approval ..read more

Bausch + Lomb Corporation, announced that the U.S. Food and Drug Administration (FDA) has approved Miebo™ (perfluorohexyloctane ophthalmic solution; formerly known as NOV03), for the treatment of the signs and symptoms of dry eye disease (DED). Miebo is the first and only FDA-approved treatment for DED that directly targets tear evaporation. “Today’s FDA approval of Miebo further advances DED treatment by addressing a significant unmet need for millions of people suffering with this disease,” said Brent Saunders, chairman and CEO, Bausch + Lomb. “We are proud to bring to market ..read more

In continuation of my update on Lumryz Avadel Pharmaceuticals plc   a biopharmaceutical company announced   the U.S. Food & Drug Administration (FDA)  final approval to Lumryz, an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. With final approval, Lumryz becomes the first and only FDA approved once-at-bedtime oxybate for people living with narcolepsy. Lumryz was additionally granted Orphan Drug Exclusivity by the FDA. “Tod ..read more

In continuation of my update on phenylephrine hydrochloride Phenylephrine Tropicamide Eyenovia, Inc, announced  the U.S. Food and Drug Administration (FDA)  approval of Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. This represents the first approved fixed dose combination of tropicamide and phenylephrine in the United States and also the first product using Eyenovia’s proprietary Optejet device to be approved by any regulator ..read more

Biogen Inc. (Nasdaq: BIIB) announced the U.S. Food and Drug Administration (FDA)   approval of  Qalsody (tofersen) 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain (NfL) observed in patients treated with Qalsody. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).1 The ongoing Phase 3 ATLAS study ..read more