PRN Pharmacal Receives the Full US FDA Approval for KBroVet to Control Seizures in Dogs with Idiopathic Epilepsy

Shots: The US FDA has granted full approval to KBroVet (potassium bromide chewable tablets) under NADA for the control of seizures associated with idiopathic epilepsy in dogs KBroVet offers benefits for dogs, incl. renal excretion via glomerular filtration for those with liver issues, once-daily dosing, & flavored, chewable tablets formulated specifically for dogs KBroVet has a…

ByRidhi RastogiFebruary 13, 2026

NEWS

Encora Therapeutics’ Encora X1 Gains the US FDA 510(k) Clearance for Essential Tremor

Shots: The US FDA has granted 510(k) clearance to Encora X1 to help relieve hand tremors in the treated limb during stimulation in adults with essential tremor Clearance was backed by a sham-controlled trial & a 90-day home-use study, both demonstrating improvements in tremor severity & functional tasks, supporting the device’s ability to assist with…

ByRidhi RastogiFebruary 13, 2026

NEWS

The EC Approves Amgen’s Uplizna (Inebilizumab) to Treat Generalized Myasthenia Gravis (gMG)

Shots: The EC has approved Uplizna (inebilizumab) as an add-on treatment of anti-AChR & anti-MuSK antibody positive adults with gMG Approval was based on P-III (MINT) trial in 238 adults with gMG (190 AChR+, 48 MuSK+), where pts received 2 Uplizna loading doses followed by 2 doses/year Pts on steroids began tapering at Wk. 4,…

ByRidhi RastogiFebruary 13, 2026

NEWS

Adlai Nortye Doses First Patient in the P-I Trial of AN9025 to Treat Solid Tumors Harboring RAS Mutations

Shots: Adlai Nortye has dosed the first patient in the US with AN9025 in its ongoing P-I trial for the treatment of advanced or metastatic solid tumors harboring RAS mutations Trial is being conducted by Adlai Nortye with ASK Pharm as a multi-regional study under a license agreement granting Adlai Nortye ex-China rights to AN9025,…

ByRidhi RastogiFebruary 12, 2026

NEWS

Lotus Pharmaceutical Partners with Formycon to Commercialize FYB206 (Biosimilar, Keytruda) across APAC Region

Shots: Formycon & Lotus have reported the conclusion of their exclusive license agreement for Formycon’s FYB206, a biosimilar version of Keytruda (Pembrolizumab), in the APAC market Upon closing, Formycon will receive an upfront payment, plus potential development & regulatory milestone payments, & a share of gross profits after launch, while retaining responsibility for manufacturing &…

ByRidhi RastogiFebruary 12, 2026

NEWS

Ark Biopharmaceutical Receives the FDA IND Clearance to Initiate P-II Trial of AK3280 in Idiopathic Pulmonary Fibrosis

Shots: The US FDA has granted IND Clearance to initiate P-II PoC trial of AK3280 in the US for the treatment of idiopathic pulmonary fibrosis (IPF) The P-II PoC trial will evaluate AK3280 (PO) vs PBO & an active comparator in IPF pts, aiming to generate key clinical data to support future regulatory filings &…

ByRidhi RastogiFebruary 12, 2026

NEWS

Labcorp Launches Elecsys pTau-181 Test to Help Rule Out Alzheimer’s Disease in the US

Shots: Labcorp has launched the Elecsys pTau-181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology in individuals (≥55yrs.) The test delivers a 97.9% negative predictive value to help rule out Alzheimer’s pathology in symptomatic pts & offers a less invasive, more accessible alternative to brain scans or lumbar punctures…

ByRidhi RastogiFebruary 12, 2026

NEWS

Novocure Receives the US FDA Approval of Optune Pax with CT for Pancreatic Cancer

Shots: Approval was based on the P-III (PANOVA-3) trial assessing Optune Pax, a TTFields device used concomitantly with gemcitabine & nab-paclitaxel (n=285), vs CT alone (n=286) in 571 adults with locally advanced pancreatic cancer Trial improved mOS to 16.2 vs 14.2mos. in ITT, with 1yr. survival of 68.1% vs 60.2%. In mPP (198 received Optune…

ByRidhi RastogiFebruary 12, 2026

NEWS

Merck Receives the FDA Approval for Keytruda and Keytruda Qlex, Plus CT ± Avastin to Treat PD-L1+ Pt-Resistant Ovarian Carcinoma

Shots: The US FDA has approved Keytruda/Keytruda Qlex + paclitaxel ± Avastin for the treatment of adults with PD-L1+ (CPS ≥1) Pt-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received 1 or 2 prior systemic therapy Approval was based on the P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda (400mg, IV, Q6W) with CT…

ByRidhi RastogiFebruary 12, 2026

NEWS

Upstream Bio Reports Topline P-II (VALIANT) Trial Data on Verekitug in Severe Asthma

Shots: The global P-II (VALIANT) trial data assessed Verekitug vs PBO in 478 pts with severe asthma for ~60wks., with a minimum of 24wks. of treatment. Eligible pts could then enroll in the VALOUR LTE trial Trial met its 1EP, reducing annualized asthma exacerbation rates by 56% (100mg; Q12W) & 39% (400mg, Q24W), with FEV1…

ByRidhi RastogiFebruary 11, 2026

Ridhi Rastogi

PRN Pharmacal Receives the Full US FDA Approval for KBroVet to Control Seizures in Dogs with Idiopathic Epilepsy

Encora Therapeutics’ Encora X1 Gains the US FDA 510(k) Clearance for Essential Tremor

The EC Approves Amgen’s Uplizna (Inebilizumab) to Treat Generalized Myasthenia Gravis (gMG)

Adlai Nortye Doses First Patient in the P-I Trial of AN9025 to Treat Solid Tumors Harboring RAS Mutations

Lotus Pharmaceutical Partners with Formycon to Commercialize FYB206 (Biosimilar, Keytruda) across APAC Region

Ark Biopharmaceutical Receives the FDA IND Clearance to Initiate P-II Trial of AK3280 in Idiopathic Pulmonary Fibrosis

Labcorp Launches Elecsys pTau-181 Test to Help Rule Out Alzheimer’s Disease in the US

Novocure Receives the US FDA Approval of Optune Pax with CT for Pancreatic Cancer

Merck Receives the FDA Approval for Keytruda and Keytruda Qlex, Plus CT ± Avastin to Treat PD-L1+ Pt-Resistant Ovarian Carcinoma

Upstream Bio Reports Topline P-II (VALIANT) Trial Data on Verekitug in Severe Asthma

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