Novo Nordisk Reports the US FDA’s NDA Acceptance of Oral Wegovy for Weight Management

Shots: The US FDA has accepted NDA of oral Wegovy for chronic weight management & major adverse CV events risk reduction in adults with obesity or overweight & comorbidities (PDUFA: Q4’25) Submission was based on the P-III (OASIS 4) trial assessing oral Wegovy (25mg; OD) vs PBO over 64wks. (incl. 12wk. dose escalation & 7wk.…

ByRidhi RastogiMay 5, 20250Comments

INSIGHTS+

The US FDA New Drug Approvals in April 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of April 2025 The US FDA has approved a total of 3 new drug including 1 new molecular entity and 2 Biologics leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was Johnson & Johnson’s…

ByDipanshu Dixit16 hours ago0Comments

Video

LIFE SCIENCES | DAILY NEWS | MAY 13, 2025 | PHARMASHOTS

ByTushar Maurya17 hours ago0Comments

News

Mentice Reports US Launch of Ankyras 4.0 to Advance Patient-Specific Aneurysm Planning for Neuro Interventions

Shots: Following FDA 510(k) clearance, Mentice has launched Ankyras 4.0 for pts-specific flow diverter planning to treat intracranial aneurysms in the US Ankyras 4.0 introduces DICOM node integration, a redesigned user interface & broader accessibility via online platform & mobile apps, plus its integration with VIST simulation allows virtual case rehearsal to accelerate decision-making &…

ByRidhi Rastogi17 hours ago0Comments

News

Spice Biotechnologies Partners with AbTherx to Discover Antibodies in Immuno-Oncology

Shots: AbTherx has entered into a multi-program antibody discovery partnership with Spice Biotechnologies to identify antibodies against targets selected by Spice Bio, using AbTherx’s Atlas Mouse technologies As per the deal, Spice Bio will obtain rights to develop & commercialize antibodies from the collaboration in exchange for research payments, potential clinical & commercial milestones, plus…

ByRidhi Rastogi18 hours ago0Comments

News

QIAGEN to Acquire Genoox for ~$80M

Shots: QIAGEN has entered into a definitive agreement to acquire Genoox, a provider of AI-driven software that allows clinical laboratories to scale & accelerate the analysis of complex genetic tests As per the deal, Genoox will receive $70M in cash & up to $10M in additional milestone payments Acquisition adds Franklin, Genoox’s cloud-based platform, to…

ByRidhi Rastogi19 hours ago0Comments

News

Genentech Reports P-III (APHINITY) Trial Data of Perjeta Regimen for Early-Stage Breast Cancer

Shots: Genentech has reported 10yr. P-III (APHINITY) trial data assessing Perjeta + Herceptin & CT vs Herceptin + CT vs PBO as an adj. therapy in 4804 pts with operable HER2+ early-stage breast cancer After 10yrs, trial depicted improved OS, with 91.6% pts alive vs 89.8% on Herceptin + CT & PBO, with sustained invasive…

ByRidhi Rastogi21 hours ago0Comments

News

MavriX Bio Reports the US FDA’s IND Clearance of MVX-220 for Angelman Syndrome

Shots: The US FDA has approved IND application of MVX-220 for the treatment of Angelman Syndrome (AS) to initiate P-I/II (ASCEND-AS) trial, with first pts dosing expected in H2’25 The P-I/II trial will evaluate the safety, tolerability, & effectiveness of MVX-220 in both adult & pediatric pts with multiple AS genotypes, incl. rare types like uniparental…

ByRidhi Rastogi22 hours ago0Comments

News

UK’s MHRA Approves AstraZeneca’s Trixeo Aerosphere with Near-Zero GWP Propellant for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The UK’s MHRA has approved Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) with HFO-1234ze(E), a next-generation, near-zero global warming potential (GWP) propellant for treating COPD in adults; regulatory review is ongoing in EU, China & other regions Approval was based on a next-generation propellant clinical development program assessing Trixeo + HFO-1234ze(E) vs Trixeo + HFA-134a,…

ByRidhi Rastogi23 hours ago0Comments

SPOTLIGHT

CXO Talks: Colin Banas from DrFirst in an Illuminating Conversation with PharmaShots

In the CXO Talks podcast, PharmaShots engaged in a riveting dialogue exchange with Colin Banas, Chief Medical Officer at DrFirst. Colin highlights the evolution of DrFirst from becoming a leader in the e-prescribing space to an end-to-end medication management company Colin talks about its collaborators, Wise Hospice Options, achieving a new milestone by reducing the…

ByHimanshu Sehgal2 days ago0Comments

THOUGHTSPOT

Innovative orthodontic solutions revolutionizing patient care and treatment results

The field of orthodontics is undergoing a significant transformation, driven by cutting-edge technologies and patient-centric approaches. Innovations in this area are not only enhancing treatment outcomes but also revolutionizing the overall patient experience. As these advancements continue to evolve, they are shaping the future landscape of orthodontic care. The evolving landscape of orthodontic care is…

ByPam Brown2 days ago0Comments

Novo Nordisk Reports the US FDA’s NDA Acceptance of Oral Wegovy for Weight Management

The US FDA New Drug Approvals in April 2025

LIFE SCIENCES | DAILY NEWS | MAY 13, 2025 | PHARMASHOTS

Mentice Reports US Launch of Ankyras 4.0 to Advance Patient-Specific Aneurysm Planning for Neuro Interventions

Spice Biotechnologies Partners with AbTherx to Discover Antibodies in Immuno-Oncology

QIAGEN to Acquire Genoox for ~$80M

Genentech Reports P-III (APHINITY) Trial Data of Perjeta Regimen for Early-Stage Breast Cancer

MavriX Bio Reports the US FDA’s IND Clearance of MVX-220 for Angelman Syndrome

UK’s MHRA Approves AstraZeneca’s Trixeo Aerosphere with Near-Zero GWP Propellant for Chronic Obstructive Pulmonary Disease (COPD)

CXO Talks: Colin Banas from DrFirst in an Illuminating Conversation with PharmaShots

Innovative orthodontic solutions revolutionizing patient care and treatment results

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