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FDA agrees to review Moderna's amended mRNA-based flu vaccine application; Lilly builds orforglipron stock ahead of approval

Last week, the US Food and Drug Administration (FDA) had said it will not review Moderna’s application for its experiment...

Impressions : 1133

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 : 1445

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 : 952

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 : 1421

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FDA agrees to review Moderna's amended mRNA-based flu vaccine application; Lilly builds orforglipron stock ahead of approval

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

Natco Pharma's Generics Idelalisib Receives Approval in US

Zydus Pharms' Generics Bosentan Receives Approval in US

Micro's Generics Colchicine Receives Approval in US

Janssen's Biologics Rybrevant Faspro Receives Approval in US

Avyxa's Avopef Receives Approval in US

Zydus's Generics Metronidazole Receives Approval in US

Macleods Pharms' Generics Colchicine Receives Approval in US

West-Ward Pharms's Generics Tapentadol Receives Approval in US

Zydus's Generics Ammonium Lactate Receives Approval in US

Macleods Pharms' Generics Milnacipran HCl Receives Approval in US

Bertrand P Cole's Receives FDA Warning Letter

Cosmetic Manufacturers's Receives FDA Warning Letter

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

Cstone Gets MHRA Nod For Sugemalimab In Stage III NSCLC In UK

Biosimilars & innovation are Dr. Reddy's growth pill

Artemis Medicare to manage 650-bed VIMHANS Hospital in Rs. 520

FDA accepts NDA for Roche's giredestrant in ESR1-Mutated

FDA Approves Venclexta, Acalabrutinib For Untreated CLL Leukemia

US FDA Approves Vanda's Antipsychotic Pill, Shares Climb

Roche Seeks Partner to Take Over Plant, Produce Key Antibiotic

Supreme Court Steps in: Trump's Rmergency tariffs Struck Down

Virion Therapeutics Shows Strong, Lasting Anti-HBV Response

Moonlake Reports Positive Phase 2 Trial Results For Sonelokimab

Generic Industry Opposes Fee Breaks for U.S. Firms

Zydus Gets USFDA Nod For Bosentan 32mg Oral Suspension

Patent Growth And Lawsuits Deter Generic Pharma Rivals

Dr Reddy's Readies Day-1 Launch Of Semaglutide Generic

Axsome Pharma Resolves SUNOSI Patent Dispute With Alkem Labs

Zydus Gets USFDA Nod For Ammonium Lactate Cream 12%

NATCO Receives CDSCO Approval For Semaglutide In India

Biocon Targets Growth With Generic Weight-Loss Drugs

Akums Receives First UK MHRA Approval For Rivaroxaban

Difgen Pharma Secures FDA Approval for Fluorometholone Eye Drops

Cstone Gets MHRA Nod For Sugemalimab In Stage III NSCLC In UK

Biosimilars & innovation are Dr. Reddy's growth pill

FDA accepts NDA for Roche's giredestrant in ESR1-Mutated

FDA Approves Venclexta, Acalabrutinib For Untreated CLL Leukemia

Virion Therapeutics Shows Strong, Lasting Anti-HBV Response

Moonlake Reports Positive Phase 2 Trial Results For Sonelokimab

Lonza Boosts Bioconjugate Innovation With Improved Synthesis

Guselkumab Maintains Ulcerative Colitis Remission For 3 Years

MDC Invites Biological E To Discuss Pneumovax 14 Pricing

Abivax Unveils Obefazimod's Anti-Fibrotic Activity In IBD

Aurobindo Pharma To Increase Pen-G Production Capacity To 10K MT

Maharashtra Sets Up 201 Bulk Drug Units in Konkan in 10 Years

Procurement Lessons From India's Pharma Sector

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

Cassidy Identifies Fda Regulatory 'Black Box' Improvements

FDA Untitled Letter Lambastes Claims In Ad For J&J's Tremfya

Pharma Firms Asked For Side-Effects Of Common Medicines

NHS Confederation Reacts To NHS England Letter On Bone Cement

Maharashtra FDA Cancels 27, Suspends 94 Drug Licences

FDA Expert Panels Under Scrutiny For Potential FACA Violations

FDA Warns Contract Manufacturer And Clinical Investigator

29 Vitamin-Mineral FDC Drugs Under Review For Possible Ban

USFDA Issues Form 483 With 6 Observations To Enzene Biosciences'

Haryana FDA Raids Target Drugs in Hisar, Karnal, and Kalanwali

Artemis Medicare to manage 650-bed VIMHANS Hospital in Rs. 520

Dror Ortho-Design Gets FDA Clearance For Advanced Smile

Autonomix Medical To Present Long-Term Pain Mitigation Data