Pharma & Biotech News #PharmaBuzz

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Weekly News Recap #Phispers

FDA chief Marty Makary resigns after rocky tenure; Italy's Angelini to buy Catalyst Pharma for US$ 4.1 billion

The US Food and Drug Administration (FDA) has seen several high profile exits under the Trump Administration. The most high pro...

Impressions : 1084

FDA issues warning letter to Intas' plant in north India; okays Axsome's drug for Alzheimer's-related agitation

In Phispers this week, India’s Intas Pharmaceuticals received a warning letter from the US Food and Drug Administration (...

Impressions : 1813

India's Sun Pharma acquires Organon for about US$ 11.75 bn; Lilly to buy Ajax Therapeutics for up to US$ 2.3 bn

In Phispers this week, Indian drugmaker Sun Pharmaceutical acquired Jersey-based Organon in an all-cash deal valued at about US...

Impressions : 1713

Lilly buys biotech Kelonia for up to US$ 7 bn; Trump orders priority review of psychedelic drugs to treat mental illnesses

Eli Lilly has been on an acquisition spree this year. After buying Ventyx Biosciences, Orna Therapeutics, CrossBridge Bio, and...

Impressions : 1450

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FDA chief Marty Makary resigns after rocky tenure; Italy's Angelini to buy Catalyst Pharma for US$ 4.1 billion

FDA issues warning letter to Intas' plant in north India; okays Axsome's drug for Alzheimer's-related agitation

India's Sun Pharma acquires Organon for about US$ 11.75 bn; Lilly to buy Ajax Therapeutics for up to US$ 2.3 bn

Lilly buys biotech Kelonia for up to US$ 7 bn; Trump orders priority review of psychedelic drugs to treat mental illnesses

Mylan's Generics Levetiracetam Receives Approval in US

Dr. Reddy's Generics Empagliflozin Receives Tentative Nod in US

Lachman's Dolutegravir, Lamivudin Receives Tentative Nod in US

Micro's Generics Brimonidine Tartrate Receives Approval in US

Zydus' Generics Hydrocortisone Sodium Receives Approval in US

Accord Biopharma's Biologics Ennumo Receives Approval in US

I3 Pharms' Generics Paliperidone Receives Approval in US

Sandoz's Generics Vasopressin Receives Approval in US

Zhejiang Novous's Generics Voriconazole Receives Approval in US

Yichang Humanwell's Generics Bupropion Receives Approval in US

Pharmacal Issues Nationwide Recall of MG217 Eczema Cream

Mukesh B Chandre's Receives FDA Warning Letter

IDO Pharma's Receives FDA Warning Letter

ProRx's Receives FDA Warning Letter

Enforcement Report - Week of May 6, 2026

CareFusion 213's Receives FDA Warning Letter

Ava's Receives FDA Warning Letter

Active Cosmetics Manufacturing's Receives FDA Warning Letter

Respilon Production S R O's Receives FDA Warning Letter

Intas' Receives FDA Warning Letter

Valion Bio Reports First Quarter 2026 Financial Results

BMS Partners With Tempus To Enhance Clinical Success With AI

Inhibrx Reports First Quarter 2026 Financial Results

Biogen Completes Acquisition Of Apellis Pharmaceuticals

Atrium Therapeutics Reports First Quarter 2026 Financial Results

Astrazeneca Follows Merck With Phase 3 Win In Bladder Cancer

Regenxbio Hits Duchenne Milestone, Eyes 2027 FDA Approval

Biotech leaders pitch Pazdur as next FDA chief

Biogen's Anti-Tau Drug Misses Phase 2, Shows Efficacy Signals

Vyome Acquires Exclusive License For Selective JAK Inhibitor

Semaglutide Price Drop Expected Amid Generic Expansion In India

Generic Entry Sparks GLP-1 Boom in India

Lupin Receives U.S. FDA Approval For Famotidine Injection, USP

FDA Accepts Transpire Bio's ANDA for Generic Trelegy® Ellipta®

Avenacy Launches Tranexamic Acid in 0.7% NaCl for U.S. Market

Biocon Arm Wins Health Canada Nod for Antifungal Drug

Inhibrx Combo Outperforms Keytruda in Tumor Shrinkage

Semaglutide Race: Torrent Grabs 38% Market Share

Amazon Adds Ozempic Pill To Same-Day Prescription Drug Kiosks

Onesource Supports Second Generic Semaglutide Approval In Canada

Valion Bio Reports First Quarter 2026 Financial Results

Inhibrx Reports First Quarter 2026 Financial Results

Atrium Therapeutics Reports First Quarter 2026 Financial Results

Astrazeneca Follows Merck With Phase 3 Win In Bladder Cancer

Biogen's Anti-Tau Drug Misses Phase 2, Shows Efficacy Signals

Vyome Acquires Exclusive License For Selective JAK Inhibitor

FDA Approves Blood Cancer Drugs From Beone And Taiho

Eli Lilly Introduces Lormalzi For Early Alzheimer's Treatment

From Mscs To Ipscs: Building The Cell Therapy Future

The Rise of GPCRs, Radiopharma & Peptide Screening

Imports Of Bulk Drugs Decline 3.31 Per Cent In FY26

Patent Pause: Link Extensions to Pendency

EUROAPI statement regarding the Brindisi site

Medisca & dsm–firmenich Expand Pharma-Grade Vitamin APIs in U.S.

Drugmakers Seek NPPA Aid as Platinum Surge Hits Cancer Drug

BMS Wins EU Approval for Sotyktu in Active Psoriatic Arthritis

Carbogen Amcis Shanghai Site Passes Surprise NMPA GMP Inspection

India's Emerging Pharma Powerhouses

Lilly Pledges $4.5 Billion More To Indiana Manufacturing Campus

DC Granules: Sitagliptin, Empagliflozin, Dapagliflozin, Metformin

FDA Official Details Top Observations From QMSR Inspections

Indoco Remedies Clears Malta Medicines Authority Audit

FDA Drafts Guidelines On High-Risk Solvents Post Tainted Syrup

Eli Lilly Halts India Obesity Campaign Amid Regulatory Scrutiny

Exporters Face WHO GMP CoPP Delays on ONDLS Online Platform

FDA Rejections Cite Manufacturing and Data Gaps as Key Hurdles

Kennedy Officials Mulled U.S. Ban on Common Antidepressants

Drug Regulator Cracks Down on Late Safety Reports by Pharma

CDSCO to Reject Pending Online Applications After 3 Reminders

Makary Announces One-Day Inspection Pilot For Low-Risk Facilities

BMS Partners With Tempus To Enhance Clinical Success With AI

U.S. Monitors 41 Cruise Passengers For Hantavirus

AUA Guidelines Strengthen Recommendation For Aquablation Therapy