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FDA refuses to review Moderna's mRNA-based flu vaccine application; Lilly buys Orna for up to US$ 2.4 billion

The US Food and Drug Administration (FDA) has said it will not review Moderna’s application for its experimental influenz...

Impressions : 1061

Lilly expects 25% growth, Novo sees its sales drop in 2026; Amgen turns down FDA request to withdraw rare disease drug

In this week’s Phispers, we bring you the split story of two GLP-1 drugmakers — Eli Lilly and Novo Nordisk. While L...

Impressions : 827

US exits WHO; Moderna to stop investing in new late-stage vaccine trials due to increased opposition to immunizations

Public health suffered several setbacks over the last week. First, the United States formally exited the World Health Organiza...

Impressions : 1340

J&J's 2026 sales may cross US$ 100 bn; FDA delays fast-track reviews of drugs under Trump's voucher program

In 2022, Pfizer had crossed US$ 100 billion in revenue owing to its Covid products. While that was a one-off, Johnson & Johnson...

Impressions : 1181

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FDA refuses to review Moderna's mRNA-based flu vaccine application; Lilly buys Orna for up to US$ 2.4 billion

Lilly expects 25% growth, Novo sees its sales drop in 2026; Amgen turns down FDA request to withdraw rare disease drug

US exits WHO; Moderna to stop investing in new late-stage vaccine trials due to increased opposition to immunizations

J&J's 2026 sales may cross US$ 100 bn; FDA delays fast-track reviews of drugs under Trump's voucher program

Ajanta Pharma's Generics Methazolamide Receives Approval in US

Mankind Pharma's Generics Ticagrelor Receives Approval in US

Steranco's Generics Nystatin Receives Approval in US

Gland's Generics Zoledronic Acid Receives Approval in US

Apotex's Generics Hydrocortisone Succinate Receive Approval in US

Alembic's Generics Carbidopa, Levodopa Receives Approval in US

MSN's Generics Bumetanide Receives Approval in US

Hikma's Generics Aztreonam Receives Approval in US

Aurobindo's Generics Solriamfetol Receives Tent. Approval in US

Eugia' Generics Nintedanib Receives Tentative Approval in US

Conceive Fertility Center's Receives FDA Warning Letter

Boothwyn Pharmacy's Receives FDA Warning Letter

Signature Formulations' Receives FDA Warning Letter

Bio Medical Manufacturing's Receives FDA Warning Letter

Mark S Dacey's Receives FDA Warning Letter

Central Coast Multispecialty's Receives FDA Warning Letter

ProDx Health's Receives FDA Warning Letter

Enforcement Report - Week of February 4, 2026

Cohance Lifesciences' Receives FDA Warning Letter

HTO Nevada's Receives FDA Warning Letter

FDA Approves Label Changes for 6 Menopausal Hormone Therapies

Seres To Reduce Staff By 30% Amid Shift To Emerging Programs

Sanofi Names Belén Garijo as New CEO

Orion Group Financial Statement Release January–December 2025

Notice to the Annual General Meeting of Orion Corp

Difgen Pharma Secures FDA Approval for Fluorometholone Eye Drops

Bridgebio Advances Achondroplasia Drug On Strong Data

EU Approves Amgen's Uplizna for Generalized Myasthenia Gravis

Lancet: 1 in 2 at Cataract Blindness Risk Need Surgery

EMA Finalizes Safety Guidelines for Pregnant, Breastfeeding Women

Difgen Pharma Secures FDA Approval for Fluorometholone Eye Drops

SFDA Approves OneSource's Generic Semaglutide in Saudi Arabia

GSK, Teva Quietly Settle Coreg 's Label' Dispute

Warburg-Mubadala Team Up, Emerge As Frontrunner For Encube

Hims Quits On Obesity Pill After Legal, Regulatory Heat

SQ Innovation Launches Lasix® ONYU With U.S. Pharma Distributors

Pharma Companies Advocate For Policy Clarity To Safeguard

Pharma Companies Advocate For Policy Clarity To Safeguard

Alembic Pharma Receives USFDA Approval For Generic Parkinson's

Makary Criticizes 'Illegal Copycat Drugs' Amid Hims' Compounded

FDA Approves Label Changes for 6 Menopausal Hormone Therapies

Bridgebio Advances Achondroplasia Drug On Strong Data

10x Genomics Reports Q4, FY 2025 Financial Results and 2026

Prothena Reports Q4, FY 2025 Results on Feb. 19, 2026

Bavarian Nordic Unveils 2025 Financials, Offers 2026 Outlook

Yosemite Announces More Than $18 Million Deployed In Grants

Australian Innovators Secure $27M for Breast Cancer Research

Zymeworks To Present 2025 Financial Results, Host Conference

Zelluna ASA: Achieves Key Milestone With Q4 2025 CTA Submission

Zealand Pharma Sets Feb. 19 Call on 2025 Results

Fresenius, Phlow Link Up To Boost US Epinephrine Injection Supply

Lalitpur Bulk Drugs Park In UP Commences Phase-I With Approved

Sun Pharma To Pump In Rs 500 Cr In Assam Manufacturing Unit

Bdmai Launches E-Marketing Portal For Indian Pharma Expansion

Fis Successfully Completes €770 Million Bond Issuance

Wanbury Reaches First Sales Invoicing Shipment Milestone

Piramal Pharma Solutions Launches Tablet-In-Capsule Services

Lilly Drafts Plan For Last Of 4 New US Drug Manufacturing Plants

FDA Launches Program to Boost Domestic Drug Manufacturing

Wanbury Reveals Tanuku API Facility, Aims For Rs. 100 Crore

NIH Stops Xarelto Arm Of Stroke Trial Due To Safety, Efficacy

FDA Cites Novo Nordisk For Airing Misleading Wegovy Ad

Haryana FDA Cracks Down on Banned Vet Drugs to Protect Livestock

FDA Untitled Letters Target Drug Ads From Novo, Argenx, Sobi

US FDA Inspects Anuh Pharma's Tarapur Facility

Piramal's Plant: Supreme Court to Gujarat Pollution Control Board

Hims & Hers' Woes Compound as FDA Hit Company With Warning Letter

BDCDA Urges Distributors To Limit Codeine Narcotic Drug Supply

HIMS Investors Can Join HIMS & Hers Health Fraud Probe

CDSCO Seeks Feedback On Importing In Vitro Diagnostics Into India

Lancet: 1 in 2 at Cataract Blindness Risk Need Surgery

EMA Finalizes Safety Guidelines for Pregnant, Breastfeeding Women

Encora Therapeutics Receives FDA 510(k) Clearance for Encora X1