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Weekly News Recap #Phispers

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 : 773

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 : 770

Lilly cuts price of Zepbound; leaked memo on child deaths due to Covid vaccines triggers reaction from former FDA chiefs

In Phispers this week, Eli Lilly reduced prices of its obesity drug Zepbound sold through LillyDirect, aiming to expand access...

Impressions : 1002

Lilly becomes first pharma to hit US$ 1 tn valuation; FDA clears Padcev-Keytruda combo for bladder cancer

In Phispers this week, Eli Lilly became the first pharmaceutical company to reach a market valuation of US$ 1 trillion, driven ...

Impressions : 1390

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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

Lilly cuts price of Zepbound; leaked memo on child deaths due to Covid vaccines triggers reaction from former FDA chiefs

Lilly becomes first pharma to hit US$ 1 tn valuation; FDA clears Padcev-Keytruda combo for bladder cancer

Aurobindo Pharma's Generics Cariprazine Receives Approval in US

Ibsa Inst Bio's Vybrique Receives Approval in US

Ascent' Generics Buprenorphine & Naloxone Receives Approval in US

Lib ,'s Biologics Lerochol Receives Approval in US

Entasis Therap's Nuzolvence Receives Approval in US

Milestone Pharma ,'s Cardamyst Receives Approval in US

Amneal's Generics Deflazacort Receives Approval in US

Mylan's Generics Octreotide Acetate Receives Approval in US

Amphastar Pharms' Generics Teriparatide Receives Approval in US

Senores Pharms' Generics Deferiprone Receives Approval in US

Enforcement Report - Week of December 17, 2025

Green Valley Fertility Partners' Receives FDA Warning Letter

Microvascular Tissue's Receives FDA Warning Letter

Sklar Personal Care's Receives FDA Warning Letter

3D Imaging Drug Design's Receives FDA Warning Letter

StuffbyNainax Issues Voluntary Nationwide Recall for Supplement

Enforcement Report - Week of December 10, 2025

MediNatura Issues Voluntary Nationwide Recall of Nasal Spray

CDL Services' Receives FDA Warning Letter

DeVere Manufacturing's Receives FDA Warning Letter

Neurocrine's Movement Disorder Treatment Fails Late-Stage Trial

J&J vows appeal after US jury hits it with record $1.5B talc

Novo Nordisk shares jump after US approves Wegovy pill

Pfizer Says Patient Dies After Receiving Hemophilia Drug in Trial

Astrazeneca's Ph. 3 Cancer Fail Is Latest Blow To ATR Inhibitors

Boehringer Spells Out A $448M Future For Rectify's ABC Program

Gilead pays $35M to license pair of HSV assets from Assembly Bio

Ipsen's ADC push leads to $1B deal for preclinical Simcere drug

Discover Fareva Unterach's expertise in high-tech pre-filled syri

Bharat Biotech, Biofabri In Tech Transfer Deal For TB Vaccine

Indian Pharma Hails FDA's BA/BE Safety Reporting Stance

Samsung Bioepis Launches Ustekinumab Biosimilar In Japan

Granules India Gets USFDA Tentative Approval For Amphetamine ER

FDA Approves Alembic's Travoprost Ophthalmic Solution USP

Senores Pharmaceuticals To Acquire Apnar Pharma And Five Andas

Cosette Pharma Launches Generic CIPRO HC With (CGT) Exclusivity

Amphastar Announces FDA Approval For Teriparatide Injection

Shilpa Pharma Gets EU Approval For Rotigotine Transdermal Patch

Senores Pharma Introduces Deferiprone Tablets USP In US

Glenmark Pharma USA To Launch Leucovorin Calcium Injection

Pfizer Says Patient Dies After Receiving Hemophilia Drug in Trial

Astrazeneca's Ph. 3 Cancer Fail Is Latest Blow To ATR Inhibitors

Boehringer Spells Out A $448M Future For Rectify's ABC Program

Gilead pays $35M to license pair of HSV assets from Assembly Bio

Ipsen's ADC push leads to $1B deal for preclinical Simcere drug

Discover Fareva Unterach's expertise in high-tech pre-filled syri

Bharat Biotech, Biofabri In Tech Transfer Deal For TB Vaccine

With Biotech Back, Analysts Make Their Picks For 2026

Applied Biocode Submits Biocode (RPP) With Kingfisher Claim

Zambon Biotech Initiates Phase 3B ADIP Study For IPX203

Symbiotec Pharmalab files DRHP with SEBI for IPO

CORONA Remedies Commissions Additional Capacity

Be Patient... Prices Of Your Medicines May Come Down Soon

Symbiosis Launches Manufacturing in New FDA-Inspected Facility

TAPI and Sagimet Biosciences Announce Global License Agreement

Bristol Myers Squibb Enhances U.S. Access To Vital Medicines

Protheragen Tackles FDA Drug Shortages with GLP-1 API Expansion

Inke Acquires Pharmanoid For Ophthalmic High Potent API Assets

Halo Pharma Enhances Manufacturing Capabilities with Macro-Pactor

DGFT Amends Measurement For Key Inputs In Metformin HCL Export

TGA Seeks Feedback On Medicine Label Changes In Australia

Shape Memory Medical Obtains EU MDR Certification For IMPEDE

FDA Posts Warning Letters To Manufacturers Of Breast Binders

Minnesota Jury Awards $65.5M vs. Johnson & Johnson

BMS' Cobenfy TV Ad Is Latest Target Of FDA Untitled Letter Spree

AZ To Pull Bleeding Reversal Agent After FDA Flags Risk Imbalance

FDA hit Catalent's Maryland Manufacturing Sites with Form 483

AKCDA Urges DCGI Action On Kerala Discount Pharmacies' Fake Drug

Novo Gets Warning Letter At Site Formerly Owned By Catalent

Trial By Fire: Over 60% Of Pharma SMEs May Be Forced To Shut Shop

Ayush Ministry Urged To Boost Single Window Clinical Trial

Colorectal Cancer Awareness Campaign Drives Diagnosis In Nigeria

New Guide: Gateway to Innovative Perioperative Nursing Mindset