Hormonal Therapies

FDA Approves Chiasma’s Mycapssa Capsules for Long-Term Maintenance Treatment in Patients with Acromegaly

NEEDHAM, Mass., June 26, 2020 (GLOBE NEWSWIRE) — Chiasma, Inc. (NASDAQ: CHMA), a commercial stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) approved MYCAPSSA®(octreotide) capsules for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA is …

Read More »

FDA Approves Tolmar’s Fensolvi for Treatment of Pediatric Patients with Central Precocious Puberty

BUFFALO GROVE, Ill., May 4, 2020 /PRNewswire/ — Tolmar Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application for FENSOLVI® (leuprolide acetate) for injectable suspension for the treatment of pediatric patients two years of age and older with central precocious puberty …

Read More »

OPKO and Pfizer Announce Positive Top-Line Results from Phase 3 Study of Somatrogon in Children with Growth Hormone Deficiency

MIAMI and NEW YORK, Oct. 21, 2019 (GLOBE NEWSWIRE) — OPKO Health Inc. (NASDAQ: OPK) and Pfizer Inc. (NYSE: PFE) announced today that the global Phase 3 trial evaluating somatrogon dosed once-weekly in pre-pubertal children with growth hormone deficiency (GHD) met its primary endpoint of non-inferiority to daily GENOTROPIN® (somatropin) for …

Read More »

FDA Approves Clarus’ Jatenzo, a New Oral Testosterone Therapy for Men with Certain Forms of Hypogonadism

NORTHBROOK, Ill., March 27, 2019 (GLOBE NEWSWIRE) — Clarus Therapeutics, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved JATENZO® (testosterone undecanoate capsules for oral use) (CIII) for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism …

Read More »

Ascendis Pharma’s Phase 3 Trial Demonstrated Superior Efficacy and Comparable Safety and Tolerability of TransCon hGH to a Daily Growth Hormone

COPENHAGEN, Denmark, March 24, 2019 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technology to address unmet medical needs, today announced top-line results from its pivotal phase 3 heiGHt Trial were presented at the Endocrine Society’s annual meeting, ENDO 2019, in New …

Read More »

Ascendis Pharma’s Once-Weekly TransCon Demonstrated Superiority Compared to Daily Growth Hormone in Phase 3 Trial in Pediatric Growth Hormone Deficiency

COPENHAGEN, Denmark, March 04, 2019 (GLOBE NEWSWIRE) —  Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technology to address unmet medical needs, today announced positive top-line results from the phase 3 heiGHt Trial, a randomized, open-label, active-controlled trial that compared once-weekly TransCon Growth Hormone (hGH) …

Read More »

Novo Nordisk Presents Positive Phase 2 Data for Somapacitan in Childhood Growth Hormone Deficiency

Athens, Greece, 28 September 2018 ­– Somapacitan, a novel growth hormone derivative in development for once-weekly administration of growth hormone, matched the therapeutic benefits of once-daily Norditropin® (somatropin) in a phase 2 trial in children with growth hormone deficiency.1 There are currently no approved once-weekly treatments for growth hormone deficiency. The REAL …

Read More »

Ferring and Celmatix Partner to Advance Care in Reproductive Medicine and Accelerate Development of Personalized Interventions

SAINT-PREX, Switzerland & NEW YORK–(BUSINESS WIRE)–Ferring Pharmaceuticals and Celmatix today announced an ambitious genomics collaboration aimed at uncovering new insights into ovarian biology and accelerating the development of personalized interventions in reproductive medicine and women’s health. This collaboration will leverage both Ferring and Celmatix’s significant expertise in women’s reproductive health …

Read More »

FDA Approves New Indications for Ferring’s Human Growth Hormone Zomacton

PARSIPPANY, N.J.–(BUSINESS WIRE)–Ferring Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ZOMACTON (somatropin) for injection in four additional pediatric indications: Idiopathic short stature (ISS) Short stature associated with Turner syndrome Short stature born small for gestational age (SGA) with no catch-up growth by 2 …

Read More »

Versartis’ Growth Hormone Drug Fails to Meet Primary Endpoint of Non-Inferiority in Phase 3 Study

MENLO PARK, Calif., Sept. 21, 2017 (GLOBE NEWSWIRE) — Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan, a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced that the VELOCITY Phase 3 clinical trial of somavaratan in pediatric growth hormone …

Read More »