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Weekly News Recap #Phispers

FDA issues warning letter to Chinese supplier of semaglutide; approves AstraZeneca's new treatment for hypertension

In Phispers this week, the US Food and Drug Administration (FDA) approved AstraZeneca’s first-in-class treatment for hype...

Impressions : 2060

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 : 1539

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 : 1943

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 : 1818

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FDA issues warning letter to Chinese supplier of semaglutide; approves AstraZeneca's new treatment for hypertension

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

Galderma 's Differin Epiduo Acne Gel Receives Approval in US

Gilead's Biologics Hepcludex Receives Approval in US

Mankind's Generics Sitagliptin Receives Tentative Approval in US

Steran Hlthcare's Generics Lacosamide Receives Approval in US

Rubin Research's Generics Clonazepam Receives Approval in US

Aurobindo's Generics Empagliflozin Receives Approval in US

MSN's Generics Acalabrutinib Receives Tentative Approval in US

Alembic's Generics Levothyroxine Na Receives Approval in US

Micro's Generics Mirtazapine Receives Approval in US

Actavis's Generics Linaclotide Receives Tentative Approval in US

Alchymars ICM SM's Receives FDA Warning Letter

GC America's Receives FDA Warning Letter

Sato's Receives FDA Warning Letter

Enforcement Report - Week of May 20, 2026

Alchymars ICM SM Private Limited is on FDA Import Alert List

Hangzhou Yiqi Biotechnology's Receives FDA Warning Letter

Naseem A Jaffrani's Receives FDA Warning Letter

Sourav K Mishra's Receives FDA Warning Letter

JW Nutritional's Receives FDA Warning Letter

Best Supplements Recalls WAP Capsules for Undeclared Active Drugs

Neurocrine Biosciences to Present at June Investor Conferences

Lilly Announces 3 Acquisitions to Build Infectious Disease Portfo

Outlook Tx Wins ONS-5010 Appeal Following Formal Dispute Process

Kura Posts Krazati Combo Data on Drug Designed to KRAS Inhibitors

Regeneron Opens Hyderabad Center to Scale Operational Excellence

SK Bio Links up With Colombia for Varicella Vaccine Production

CHMP Backs BRAFTOVI Combo for 1L BRAFV600E-Mutant mCRC

Menarini Group Presents New Oncology Data at ASCO 2026

Recordati fields $12.4B go-private offer

Otarmeni Receives EMA Filing Acceptance for Genetic Hearing Loss

Ionetix Gets ANDA Approval for Ga-68 Gozetotide (PSMA-11)

Brazil Approves First Generic Version of Ozempic

Jubilant Pharmova Posts FY26 Revenue Of Rs. 8,280 Crore, Up 14%

Alembic Gets USFDA Nod For Generic Levothyroxine Sodium Tablets

Hims & Hers Launches Generic Semaglutide in Canada

Takeda Pharma Ordered To Pay $2.5 Billion In Amitiza Case

Sunshine Biopharma Gets Canadian OK for Generic Amoxicillin

MedExpress Canada Launches Generic Semaglutide At $124.99

Shaily Launches Combo Product with ShailyPen Neo Technology

Upsher-Smith Launches Generic Restasis Cyclosporine Emulsion

Lilly Announces 3 Acquisitions to Build Infectious Disease Portfo

Outlook Tx Wins ONS-5010 Appeal Following Formal Dispute Process

Kura Posts Krazati Combo Data on Drug Designed to KRAS Inhibitors

SK Bio Links up With Colombia for Varicella Vaccine Production

CHMP Backs BRAFTOVI Combo for 1L BRAFV600E-Mutant mCRC

Menarini Group Presents New Oncology Data at ASCO 2026

Recordati fields $12.4B go-private offer

Otarmeni Receives EMA Filing Acceptance for Genetic Hearing Loss

Sunlight Launches Clinician-Supervised NAD+ Rx Program

All Eyes on Revolution & Bispecific Antibodies at ASCO 2026

Why Choosing the Right Mupirocin Calcium Manufacturer Matters

Gilead Inks $140M Deal With Korean API Maker Yuhan

FDA: 17 Drugs Approved via Continuous Manufacturing

Curia Completes API Aseptic Suite Upgrade in Valladolid, Spain

BioNxt Advances Semaglutide ODF into Active Pharma Development

Bulk Drugs And Intermediates Exports Grew 3.76% In FY26

Drugmakers Battle Rising Costs, Export Slump

How HRV Pharma Is Redefining Pharma Value Creation

Provectus Reports PV-10 Clears Tumors in Bladder Cancer Survivors

Piramal Pharma, Botanix Partner on Drug Substance Development

Strong Oversight Anchors India's Surging Global Pharma Footprint

FDA Issues GMP Warnings to Drugmakers in US Japan & India

SEC Recommends Discontinuation of Crizanlizumab Import Permission

Strides Pharma Gets 5 FDA Observations After Bengaluru Audit

Sandoz Urges EU to Probe Alleged China Drug Dumping

CDSCO Flags Spurious Liver Drug; 169 Others Fail Tests in April

SAHPRA, SAPC Crack Down on Unlicensed GLP-1/GIP Drugs

CDSCO: Injectables Cannot Be Marketed as Cosmetics

Centre Moves Pregabalin To Schedule H1 To Combat Drug Misuse

CDSCO Urges Public to Report Cosmetic Violations

Sheppard Pratt: Psilocybin May Cut Chronic Suicidal Ideation

Spectral AI Gets FDA De Novo Clearance for DeepView Burn System

Yunu Launches De-ID & Export for Easier Trial Data Sharing