SIMTRIYO is the first and only norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) approved for the treatment of ADHD in adults and pediatric patients aged 6 years and older weighing at least 20kg SIMTRIYO will be commercially available later this year following scheduling by the U.S. Drug Enforcement Administration (DEA) Approval is supported by results from four pivotal Phase 3 clinical trials in adults and pediatric patients demonstrating statistically significant and clinically me

Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer Enhertu® (trastuzumab deruxtecan) in combination with pertuzumab has been recomme

Multi-faceted strategy aims to enable rapid, broad and sustainable access to alimatravir (MK-8527), if approved, in low- and middle-income countries Voluntary licensing agreements cover 129 countries in regions which account for the substantial majority of new HIV diagnoses globally As Phase 3 trials continue, Merck is committed to advancing access plans, working in close collaboration with the HIV community and global health stakeholders Merck (NYSE: MRK), known as MSD outside of the United

First-to-Market Generic Entry Underscores Par Health's Commitment to Expanding Access to High-Quality, Affordable Medicines July 24, 2026 -- Par Health, Inc. ("Par Health" or the "Company"), a global pharmaceutical company and manufacturer of essential medicines, today announced the launch of its generic version of Merck's Janumet® XR (sitagliptin and metformin HCl extended-release) tablets for oral use, following final approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated

Scribe Therapeutics has overshot its own expectations with an IPO that's set to bring in $128.7 million for the in vivo gene editing outfit. Scribe is issuing 8.6 million shares—above the 7.1 million shares that the company had suggested on Monday . At $15 apiece, the biotech has also priced the shares, which will list on the Nasdaq today under the ticker “SCTX,” at the top end of the $13-15 range it had previously set out. It means the company expects to bring in $128.7 million in gross proce

Crux, a benefits operating system that connects employers, pharmaceutical manufacturers, and benefit solution providers, today announced a collaboration with global healthcare company Novo Nordisk to expand affordable and simplified access to authentic anti-obesity medications (AOMs) like Wegovy® for employer health plans across the United States. Through an alternative pharmacy benefit structure, the agreement will allow Crux to deliver a dedicated carve-out solution that provides employers an

-- FDA clearance of the IND, together with the previously cleared CTA, establishes a global Phase 1/2 clinical program for PM577a -- -- PM577a targets the H1069Q mutation in the ATP7B gene, the most prevalent WD-causing allele in North America and Europe -- -- Initial clinical data expected in 2027 -- July 23, 2026 -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today announced that the U.

Recommendation based on NEXUS data; Minoryx and Neuraxpharm expect European Commission approval by the end of this quarter July 24, 2026 -- Minoryx Therapeutics and Neuraxpharm Group, announce that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation approval under exceptional circumstances for NEZGLYAL® (leriglitazone) as a treatment for male cALD patients, aged 2-12 years with Gadolinium (Gd) negative brai

Company plans to request re-examination following negative CHMP opinion for arimoclomol MAA Zevra continues to support access to arimoclomol for eligible patients through its global Expanded Access Program July 24, 2026 -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on bringing life-changing therapeutics to people living with rare diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Med

Enveda, a clinical-stage biotech company developing first-in-class small molecules derived from life’s chemistry, had results from its Phase 1b atopic dermatitis trial presented in New York at last week’s 2026 American Academy of Dermatology (AAD) Innovation Academy, and announced its acceptance for an oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2026 in Vienna. “Patients want oral therapies; the problem is with our current orals, we take safety penal