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Trump says pharma tariffs may touch 250% in 18 months; FDA okays Jazz Pharma's rare brain tumor drug

The US Food and Drug Administration (FDA) has granted an accelerated approval to Jazz Pharmaceuticals’ Modeyso, a drug th...

Impressions : 648

Consortium makes ~US$ 3 bn offer to buy Bavarian Nordic; FDA approves PTC's rare genetic disorder drug

The US Food and Drug Administration (FDA) has approved PTC Therapeutics’ oral drug to treat a rare genetic disorder known...

Impressions : 855

Astra to invest US$ 50 bn in US to avoid tariffs; Dr. Reddy's to launch generic Wegovy in 87 countries next year

AstraZeneca and Biogen are the latest drugmakers to announce investments in the US to avoid import tariffs. AstraZeneca is in...

Impressions : 1137

Sarepta lays off 500 employees post second death in Elevidys trial; FDA chief proposes lowering PDUFA fee

This week’s Phispers brings you updates on cell and gene therapies (CGTs). After the death of a second teenaged boy last ...

Impressions : 4203

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Trump says pharma tariffs may touch 250% in 18 months; FDA okays Jazz Pharma's rare brain tumor drug

Consortium makes ~US$ 3 bn offer to buy Bavarian Nordic; FDA approves PTC's rare genetic disorder drug

Astra to invest US$ 50 bn in US to avoid tariffs; Dr. Reddy's to launch generic Wegovy in 87 countries next year

Sarepta lays off 500 employees post second death in Elevidys trial; FDA chief proposes lowering PDUFA fee

Teva's Biologics Ajovy Receives Suppl Approval in US

Jubilant's Generics Eslicarbazepine Receives Approval in US

FDC's Generics Moxifloxacin HCl Receives Approval in US

Sanofi's Avapro Receives Approval in US

Sandoz's Biologics Hyrimoz Receives Suppl Approval in US

Ascendis's Biologics Skytrofa Receives Suppl Approval in US

Alembic's Generics Carbamazepine Receives Approval in US

Annora's Generics Spironolactone Receives Approval in US

Hetero's Generics HCTZ Olmesartan Receives Approval in US

MPP Pharma's Generics Niacin Receives Approval in US

Enforcement Report - Week of August 6, 2025

Oasis Medical Recieves Warning Letter

Enforcement Report - Week of July 30, 2025

Macsen Drug Recieves Warning Letter

Kabana Skin Recieves Warning Letter

Shiva Analyticals Recieves Warning Letter

Nature's Fusions LLC Recieves Warning Letter

Medical Chemical Corporation Recieves Warning Letter

Glenmark Pharmaceuticals Recieves Warning Letter

Enforcement Report - Week of July 16, 2025

Gilead Reports 7% Sales Decline for CAR-T's Yescarta, Tecartus

FDA Says Country's IV, Injectable Saline Shortage Is Resolved

Vinay Prasad Returns to Role as Top Vaccine Regulator

FDA Approves Boehringer 's Lung Cancer Treatment

CureVac Settles mRNA Patent Dispute with Pfizer & Biontech

FDA Moves to Boost Domestic Drug Manufacturing After Trump Push

FDA Lifts Pause of Valneva's Chikungunya Vaccine in Older Adults

Kaken Strengthens Late-Stage HAE Portfolio with $32 M Astria Deal

Novartis Weighs Deal for Biotech Avidity Biosciences

IOL Chemicals post Q1 FY26 consolidated profit at Rs. 33.93 Cr

Zenara Pharma Gets FDA Nod for First Generic Sertraline

Radius Wins Patent Case for Osteoporosis Drug TYMLOS

AbbVie Celebrates as Skyrizi and Rinvoq Generate Billions

Azurity Pharma Launches BRYNOVIN™, First Oral Liquid Sitagliptin

Protagenic Therapeutics Granted New Japan Patent for Stilbenoid

FDA Reveals 2026 User Fee Rates

GLP1 Pen Manufacturer Prepares for Generic Launches

Torrent Pharmaceuticals to Launch Semaglutide After Patent Expiry

Amphastar Pharma' Q2 Earnings Conference Call on August 7, 2025

KPRDO Worries Over JAKs Selling Unapproved Generics

Vinay Prasad Returns to Role as Top Vaccine Regulator

FDA Approves Boehringer 's Lung Cancer Treatment

CureVac Settles mRNA Patent Dispute with Pfizer & Biontech

FDA Lifts Pause of Valneva's Chikungunya Vaccine in Older Adults

Kaken Strengthens Late-Stage HAE Portfolio with $32 M Astria Deal

Novartis Weighs Deal for Biotech Avidity Biosciences

Valneva Lifts FDA Pause on IXCHIQ®, Updates Prescribing Info

Immunocore Reports Q2 Financial Results

FibroGen Gets FDA Type C Meeting Win for Roxadustat in MDS

InflaRx Reports Q2 2025 Financials, Updates on Business

Axplora Announces €6.5 Million Investment at Vizag Site

Eli Lilly Confirms Plan to Sell NJ Plant

ESTEVE CDMO Buys Regis Technologies, Boosts U.S. Presence

Cohance Lifesciences Names Yann D'Herve as CDMO Business CEO

DGTR Begins Anti-Dumping Probe on China's Bromo OTBN Imports

Ofichem Acquires Swedish Site from Meribel Pharma Solutions

RPG Life Sciences Appoints Deepak Shukla as Chief Executive

Concord Biotech Passes Russian GMP Inspection at API Facility

Pharmexcil Seeks Itraconazole Supply for Dubai Buyer

48 Projects Cleared for Domestic KSM/DI/API Manufacturing

FDA Cites Firms for CGMP Violations; Unapproved Drugs Sold Online

Telangana IDMA Warns of Closures Without Schedule M Deadline

AIOCD Demands Strict Action Against Illegal E-Pharmacies

Sun Pharma, Lupin, Dr Reddy's Recall Products in US

Counterfeit Dental Products Raise Safety Concerns

Indoco's Goa Plant II Gets Eu Gmp Compliance-Certified

FDA Eyeing Study Requirements to Confirm Elevidys Safety: Report

FDA Warns Glenmark for Not Probing Dissolution Failures

PMCPA Criticizes Theramex for Severe Compliance Issues

FDA Enhances Medline, Integra Neurosurgery Kit Recall

Gates Foundation Commits $2.5 Billion to 'ignored' Women's Health

AndHealth Opens Retail Pharmacy With Family Health Services

Dxcover Adds Top Advisors To Strengthen Leadership Team