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Weekly News Recap #Phispers

Sanofi, Earendil Labs ink up to US$ 2.56 bn AI-driven autoimmune drug deal; CDC revises childhood immunization guidelines

The New Year began with two mid-size deals centered around the use of artificial intelligence (AI) in drug development. Sanofi...

Impressions : 676

BioMarin inks US$ 4.8 billion rare disease deal with Amicus; FDA approves pill version of Novo's Wegovy

PharmaCompass wishes its readers a very Happy New Year and brings news from the last two weeks in this double-dose edition of...

Impressions : 1067

FDA okays GSK's Exdensur as first biologic, add-on med for severe asthma; issues OAI status to Sun Pharma's India facility

As the year draws to a close, the US Food and Drug Administration (FDA) appears busy approving drugs at a fast pace. This week...

Impressions : 963

Lilly to invest US$ 6 bn in new API plant in Alabama; Biocon buys remaining stake in Biocon Biologics, makes it 100% subsidiary

In this week’s Phispers, Eli Lilly announced yet another investment in the US — this time to build its largest API ...

Impressions : 836

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Sanofi, Earendil Labs ink up to US$ 2.56 bn AI-driven autoimmune drug deal; CDC revises childhood immunization guidelines

BioMarin inks US$ 4.8 billion rare disease deal with Amicus; FDA approves pill version of Novo's Wegovy

FDA okays GSK's Exdensur as first biologic, add-on med for severe asthma; issues OAI status to Sun Pharma's India facility

Lilly to invest US$ 6 bn in new API plant in Alabama; Biocon buys remaining stake in Biocon Biologics, makes it 100% subsidiary

Gland's Generics Bortezomib Receives Approval in US

Upsher Smith's Generics Ciprofloxacin Receives Approval in US

Gland's Generics Olopatadine HCl Receives Approval in US

Knack's Generics Rocuronium Bromide Receives Approval in US

Mankind's Generics Extended Phenytoin Na Receives Approval In US

Taro's Generics Acetaminophen & Ibuprofen Receives Approval in US

Alkem's Generics Dapagliflozin Receives Tentative Approval in US

Hansoh's Generics Dapagliflozin Receives Tentative Approval in US

Novo Nordisk's Wegovy Receives Approval in US

RB Hlth's Mucinex Receives Approval in US

Asanuma Corporation is on FDA Import Alert List

PLZ Corp. is on FDA Import Alert List

Veganic SKN Limited is on FDA Import Alert List

Cosmetic Manufacturers (Aust) Pty. is on FDA Import Alert List

Antaria Pty. Ltd. is on FDA Import Alert List

Enforcement Report - Week of January 7, 2026

Absolutely Natural's Receives FDA Warning Letter

LiquidCapsule Manufacturing's Receives FDA Warning Letter

Tower's Receives FDA Warning Letter

FDA Issues Form 483 To Lonza Guangzhou Pharmaceutical

Benitec Bio Shows Strong, Durable Efficacy In BB-301 Ph 1B/2A

Argo Bio To Present At 44Th J.P. Morgan Healthcare Conference

Tempus Achieves Record Total Contract Value Exceeding $1.1 B

Merck Starts Phase 3 Trial Of Calderasib With Keytruda For NSCLC

FTC wins blocking Edwards Lifesciences' acquisition of JenaValve

Abivax shares soar 23% as media report reignites M&A Chatters

Zymeworks Outlines Strategic Priorities And Outlook For 2026

Teva Showcases Growth Strategy At J.P. Morgan Healthcare Conf

Day One Reveals 2025 OJEMDA Revenue, Offers 2026 Product Guidance

Kura Oncology Highlights KOMZIFTI Revenue, 2026 Milestones

FDA Confirms Para IV Patent Litigation for Brukinsa

FDA Confirms Para IV Patent Litigation for Livtencity

RVL Pharma: Santen Gets Japan Approval For UPNEEQ Mini

Granules India Secures USFDA Tentative Approval For gDYANAVEL XR

Pharmexil Holds Key Talks On India's Generic Pharma Export

Indian Pharma Companies' New Drug Filings Hit 20-Year Low: Nomura

HC Seeks Novo Nordisk's Reply On Natco Plea To Revoke Patent

Earendil Labs Announces Strategic Collaboration with Sanofi

Scinopharm Gets FDA Nod For Glatiramer Acetate Injection

CivicaScript Launches Low-Cost Insulin Biosimilar in US

Benitec Bio Shows Strong, Durable Efficacy In BB-301 Ph 1B/2A

Argo Bio To Present At 44Th J.P. Morgan Healthcare Conference

Merck Starts Phase 3 Trial Of Calderasib With Keytruda For NSCLC

Abivax shares soar 23% as media report reignites M&A Chatters

Kura Oncology Highlights KOMZIFTI Revenue, 2026 Milestones

Krystal Biotech Updates at 44th J.P. Morgan Healthcare Conference

Stoke Therapeutics Announces Updates of Zorevunersen

Debiopharm Deploys Genialis for AI-Based Biomarker Discovery

Regenxbio Spotlights Catalysts, Reveals Success in Gene Therapy

10x Genomics Announces Preliminary Q4, Full-Year 2025 Results

Pharma, Med-Tech Firms Seek PLI Extension For APIs Coverage 2026

Supriya Lifescience Boosts Capacity And Global Readiness

How to Choose a Reliable Oxytetracycline HCL API Manufacture

Understanding Sevelamer Carbonate API COA Parameters

GMP Manufacturing Challenges in Tadalafil API Production

Understanding Latanoprost API COA Parameters

Government Eyes Separate Licensing for Bulk Drugs

Telangana Pharma Companies To Discuss Lalitpur Bulk Drugs Park

Pharma Exporters To Discuss API PLI Scheme With Korea

DoP Extends PLI Timeline for Bulk Drugs to Jan. 16, 2026

Puducherry DC Dept Mandates 100% Testing to Fight Fakes

Quality Trailblazer Stresses Non-Negotiable Leadership Commitment

Global Drug Regulation Lessons From Nimesulide On Patient Safety

Aurobindo Pharma's Dyrupeg Faces Health Canada Compliance Notice

Haryana FDA Detects 33 Overpricing Violations In 2025

Telangana DCA Unveils Crackdown On Interstate Fake Medicine

Wyoming Supreme Court Throws out Abortion Bans

Haryana FDA Issues Directive On High-Risk Solvents Labelling

India Proposes Ban On OTC Syrup Sales Post Contamination Crisis

Haryana & Telangana Crack Down On Nimesulide Over 100 Mg

ICMR Releases Guidelines On HRD Scheme For Health Research

NIMHANS Study: Yoga Accelerates Opioid Withdrawal Recovery

Aimed Urges Government To Increase Medical Device Import Tariffs