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Weekly News Recap #Phispers

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 : 710

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 : 911

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 : 789

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 : 1057

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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

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

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

Amneal Pharms' Biologics Oziltus Receives Approval in US

Amneal Pharms' Biologics Boncresa Receives Approval in US

Boehringer Ingelheim Pharma's Jascayd Receives Approval in US

Cytokinetics' Myqorzo Receives Approval in US

Formyn AG's Biologics Nufymco Receives Approval in US

Creekwood Pharms' Generics Haloperidol Receives Approval in US

Teva' Generics Dapagliflozin Receives Tentative Approval in US

Enforcement Report - Week of December 31, 2025

Gold Star Issues Recall of Certain FDA-Regulated Products

Enforcement Report - Week of December 24, 2025

Maria A Carballosa's Receives FDA Warning Letter

Revive Rx dba Revive Rx Pharmacy's Receives FDA Warning Letter

Medinatura New Mexico's Receives FDA Warning Letter

Guangdong Renhe Guozhuang Biotech's Receives FDA Warning Letter

Handelnine Issues Nationwide Recall of Rheumacare Capsules

Enforcement Report - Week of December 17, 2025

Fagofarma s.r.o.'s Fails EDQM inspection

BioNTX Shows Growth, Workforce Momentum & Innovation Leadership

Mabwell's Adalimumab Biosimilar Nod For Marketing in Indonesia

Corcept Gets Complete Response Letter For Relacorilant

Elanco Gets USDA Nod For Befrena To Treat Canine Dermatitis

Modular Medical Granted 180-Day Extension For Nasdaq Bid Price

NPPA Awaits Recovery Of 85% Overcharged Amount

TN DCA Reveals 364 Safety Violations as Coldrif Survivor Returns

Ayush And Herbal Products Exports Decline 33% In October

Experts Call For Strengthening Regional Healthcare Systems

XORTX Unveils Breakthrough in Gout Pathway Research

Sun Pharma Eyes Obesity Drugs as Growth Driver

Intense Rivalry Between Lilly And Novo Opens Up India

Glenmark Pharma USA Launches Epinephrine Injection USP

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

Fresenius Kabi Launches Room-Temperature Stable Rocuronium

USFDA Approves Alembic's 0.004% Travoprost Solution

Senores Pharmaceuticals To Acquire Apnar Pharma And Five Andas

Mabwell's Adalimumab Biosimilar Nod For Marketing in Indonesia

Elanco Gets USDA Nod For Befrena To Treat Canine Dermatitis

XORTX Unveils Breakthrough in Gout Pathway Research

Alvotech Secures Term Loan Facility Of USD 100 Million

Outlook Therapeutics Updates Fda Review Of ONS-5010 For Wet AMD

Gensight Bio Gains Early Access For Gene Therapy In Israel

Dr. J. Singh Inaugurates BRIC Complex to Boost India's Biotech

Valneva, Serum Institute End Chikungunya Vaccine License Deal

Zealand Pharma Reports Shares, Voting Rights as of Dec. 31, 2025

Clearmind Medicine Restores Nasdaq Minimum Bid Price Compliance

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

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

Global Recognition Prilocaine CEP Certified by EDQM

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

Corcept Gets Complete Response Letter For Relacorilant

NPPA Awaits Recovery Of 85% Overcharged Amount

TN DCA Reveals 364 Safety Violations as Coldrif Survivor Returns

UK Regulator Warns of Risky Online Treatments

Government Bans Nimesulide Oral Formulations Above 100 mg

Doctors Warn Against Antibiotic Misuse As Resistance Threat Grows

NPPA Permits Serum Institute To Halt Production Of 2 TT Vaccine

IIL Confirms Removal Of Counterfeit Abhayrab Rabies Vaccine

Drug Firms Extend GMP Compliance Time, States IDMA

Sun Pharma Arm Recalls 17K+ Antifungal Shampoos in US

Experts Call For Strengthening Regional Healthcare Systems

Quanterix Alzheimer's Test Finds Hidden Cases In 40-Year Study

Phoenix Data Shows Canadians Embracing Dr. Google for Care