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NEWS

LIB Therapeutics Receives the FDA Approval for Lerochol (Lerodalcibep-liga) for Adults with Elevated LDL Cholesterol 

Shots:  The US FDA has approved Lerochol as an LDL-C lowering therapy for adults with hypercholesterolemia, including HeFH; US launch as a PFS is expected in spring 2026, with an autoinjector later in 2026, while EMA approval is anticipated in Jun 2026 alongside additional global regulatory filings   Approval was supported by the global P-III (LIBerate) trial, enrolling over 2,900 CVD patients and without…
December 12, 2025

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NEWS

Innoviva Specialty Therapeutics Receives the FDA Approval for Nuzolvence (Zoliflodacin) for Uncomplicated Urogenital Gonorrhea 

Shots:  The US FDA has approved Nuzolvence for the treatment of uncomplicated urogenital gonorrhea in pts (age ≥12yrs.; Wt.≥35 kg), with US commercialization planned for the H2’26  Approval was based on a pivotal P-III multinational trial (n=930) evaluating a single 3g oral dose of Nuzolvence vs ceftriaxone (500 mg IM) + azithromycin (1 g oral) for uncomplicated urogenital gonorrhea, which demonstrated non-inferiority, comparable tolerability…
December 12, 2025

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Moderna
NEWS

Moderna Reports the CHMP Positive Opinion on mNEXSPIKE to Protect Against COVID-19 

 Shots:  The CHMP has recommended mNEXSPIKE (mRNA-1283), a COVID-19 vaccine, for active immunization against SARS-CoV-2 in individuals (age≥12 yrs)  Opinion was based on the P-III trial evaluating mNEXSPIKE (mRNA-1283; 10 µg) versus Spikevax (mRNA-1273; 50 µg) in ~11,400 participants (age ≥12 yrs), with primary efficacy assessed from 14 days post-vaccination  The trial met its 1EP with mNEXSPIKE showing 9.3% superior relative vaccine efficacy (rVE) in subjects (≥12yrs.), whereas in…
December 11, 2025

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NEWS

Polpharma Biologics and Libbs Farmacêutica Enter into a Licensing Agreement for an Autoimmune Biosimilar 

 Shots:  Polpharma Biologics has signed a licensing agreement with Brazil-based Libbs Farmacêutica for an autoimmune biosimilar  Under this strategic partnership, Polpharma Biologics is fully responsible for the development and manufacturing of the product  Libbs will exclusively handle the product’s commercialization, marketing, and distribution in the Brazilian market  Ref: Polpharma Biologics | Image: Polpharma Biologics | Press Release Related News:- Polpharma Biologics Launches…
December 10, 2025

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INSIGHTS+

The US FDA New Drug Approvals in November 2025 

Shots:  Innovation surged in November, with cutting-edge science and strategic collaborations reshaping the drug development landscape across oncology, renal disease, hereditary conditions, and more  The US FDA cleared five standout therapies, including Bayer’s Hyrnuo (Sevabertinib), UCB’s Kygevvi (Doxecitine + Doxribtimine), and Arrowhead’s Redemplo, underscoring a month of meaningful clinical progress  November 2025 closed with five approvals, matching last year’s total, signaling sustained momentum and a steady…
December 9, 2025

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NEWS

Immutep Collaborates with Dr. Reddy’s to Develop & Commercialize Eftilagimod Alfa

Shots: Immutep and Dr. Reddy’s Laboratories have entered into a strategic collaboration and exclusive licensing agreement to develop and commercialize Eftilagimod Alfa (efti) across all countries outside North America, Europe, Japan, and Greater China As per the deal, Immutep will receive a $20M (~AUD 30.2M) upfront payment from Dr. Reddy’s, plus potential milestone payments of up…
December 9, 2025

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NEWS

Mirum Pharmaceuticals to Acquire Bluejay Therapeutics, Strengthening Rare Disease Portfolio

Shots: Mirum Pharmaceuticals has entered into an agreement to acquire Bluejay Therapeutics, gaining global rights to brelovitug with Breakthrough Therapy and PRIME designations, and expanding Mirum’s rare liver disease portfolio As per the deal, Mirum will acquire all Bluejay shares for $250M in cash and $370M in Mirum stock, plus up to $200M in sales-based…
December 9, 2025

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Incyte
NEWS

Incyte Reports Positive P-I Data of INCA033989 in Essential Thrombocythemia (ET) at ASH 2025 

Shots: Incyte reported updated data from two P-I trials showing the safety, tolerability, and efficacy of INCA033989 (INCA33989-101 and INCA33989-102) in 455 adults(age≥18) with mutCALR-positive MPNs, including ET & MF, findings were presented at ASH'25 In ET pts receiving higher starting doses of INCA033989 (400–2,500 mg; n=30), 90% achieved a HR, including 83.3% with CHR…
December 9, 2025

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