Skip to content Skip to footer
Subscribe Now
NEWS

Gyder Surgical Reports the US FDA’s 510(k) Clearance for Gyder Hip System

Shots: The US FDA has granted 510(k) clearance to the Gyder Hip System for positioning of the acetabular cup during anterior hip arthroplasty following approval from Australia’s TGA Gyder Hip System eliminates the use of metallic pins & pre-operative/intra-operative imaging for landmark registration, offering a less invasive approach than conventional hip navigation System features 1min…
February 5, 2025

Read more

Roche
NEWS

Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Macular Edema (DME)

Shots: The US FDA has approved Susvimo (port delivery platform with Lucentis) to treat DME Approval was based on P-III (Pagoda) study assessing Susvimo (100 mg/mL, refilled in Q6M) vs Lucentis (0.5mg, intravitreal, Q1M) in DME pts (n=634), where subjects in Susvimo arm received 4 loading doses of Lucentis till 16wks. prior to implantation Study demonstrated sustained vision…
February 5, 2025

Read more

Pfizer New
NEWS

Pfizer Reveals Data from P-III (BREAKWATER) trial of Braftovi Regimen in Patients with Metastatic Colorectal Cancer

Shots: Pfizer reported topline data of P-III (BREAKWATER) study assessing Braftovi (300mg, PO, QD) in untreated BRAF V600E-mutant mCRC pts, randomized to Braftovi + Erbitux (n=158), Braftovi + Erbitux + mFOLFOX6 (n=236), or CT (mFOLFOX6/ FOLFOXIRI/ CAPOX) ± Avastin (n=243) Study showed improved PFS (1EP) & OS (2EP) along with previously reported improved cORR…
February 4, 2025

Read more

NEWS

Algiax Pharmaceuticals Reports Topline Data from P-IIa Trial of AP-325 for Neuropathic Pain

Shots: Algiax reported topline data from the P-IIa PoC trial assessing AP-325 (GABA-A modulator) vs PBO in 99 pts with peripheral post-surgical neuropathic pain in Germany, Spain, the Czech Republic, Belgium, & France Data showed rapid PI-NRS reduction in <2wks., sustained effects, plus significantly higher ≥50% & ≥70% responder rates with ~25% vs. 11% pts…
February 4, 2025

Read more

NEWS

Datar Cancer Genetics Launches Exacta AI to Offer Personalized Treatment Options for Cancer Patients

Shots: Datar Cancer Genetics has introduced Exacta AI (multi-analyte platform) to provide ~10 evidence-based drug combinations as a treatment for cancer patients who have exhausted SoC options Exacta AI integrates 360° tumor work-up with AI-driven analysis of complex tumor interactome data to assess drug interactions, toxicity, & side effects for ADCs, CPIs, targeted therapies,…
February 4, 2025

Read more

NEWS

ClearPoint Neuro Receives US FDA’s 510(k) clearance for ClearPoint Navigation Software Version 3.0

Shots: The US FDA has granted 510(k) clearance to ClearPoint Navigation Software 3.0 that will introduce intraoperative CT workflow, expanding its use from MRI. The company is planning to initiate limited market release in Q1’25 & full release in H2’25 Navigation Software 3.0 is compatible with intraoperative CT & Conebeam CT imaging, enabling precision neurosurgery in facilities…
January 28, 2025

Read more

NEWS

Neurocrine Biosciences and Takeda Amend Partnership to Develop and Commercialize Osavampator in Japan

Shots: Neurocrine & Takeda have revised their 2020 collaboration to develop & commercialize osavampator (NBI-1065845/TAK-653), which originally granted Neurocrine exclusive license to osavampator, NBI-1070770, & the GPR139 antagonist program As per the amendment, Neurocrine will get exclusive rights to develop & market osavampator to treat major depressive disorder (MDD) globally, while Takeda will reacquire…
January 28, 2025

Read more

Load more