Pharma & Biotech News #PharmaBuzz
Lilly to invest US$ 6 bn in new API plant in Alabama; Biocon buys remaining stake in Biocon Biologics, makes it 100% subsidiary
Impressions : 576
Lilly cuts price of Zepbound; leaked memo on child deaths due to Covid vaccines triggers reaction from former FDA chiefs
Impressions : 897
Lilly becomes first pharma to hit US$ 1 tn valuation; FDA clears Padcev-Keytruda combo for bladder cancer
Impressions : 1350
Caplin's Generics Acetaminophen Receives Approval in US
05 Dec 2025 //
FDA
Mylan's Generics Macitentan Receives Approval in US
03 Dec 2025 //
FDA
MSN's Generics Brivaracetam Receives Tentative Approval in US
01 Dec 2025 //
FDA
Mankind's Generics Sugammadex Receives Tentative Approval in US
01 Dec 2025 //
FDA
Amneal's Generics Albuterol Sulfate Receives Approval in US
01 Dec 2025 //
FDA
Otsuka Pharm's Biologics Voyxact Receives Approval in US
25 Nov 2025 //
FDA
Zydus' Generics Verapamil HCl Receives Approval in US
24 Nov 2025 //
FDA
Alembic Pharms' Generics Dapagliflozin Receives Approval in US
24 Nov 2025 //
FDA
Micro's Generics Olmesartan Medoxomil Receives Approval in US
24 Nov 2025 //
FDA
Apotex's Ruxolitinib Receives Approval in US
21 Nov 2025 //
FDA
CDL Services' Receives FDA Warning Letter
09 Dec 2025 //
FDA
DeVere Manufacturing's Receives FDA Warning Letter
09 Dec 2025 //
FDA
Ningxia Taiyicin Biotech's Fails EDQM inspection
04 Dec 2025 //
EMA
Rhyz Analytical's Receives FDA Warning Letter
02 Dec 2025 //
FDA
Turbare Manufacturing's Receives FDA Warning Letter
02 Dec 2025 //
FDA
FDA Issues Form 483 to North American Custom Laboratories
26 Nov 2025 //
FDA
Wells Pharma of Houston's Receives FDA Warning Letter
25 Nov 2025 //
FDA
Owen Bio's Receives FDA Warning Letter
25 Nov 2025 //
FDA
FDA Issues Form 483 to Fareva Amboise
21 Nov 2025 //
FDA
FDA Issues Form 483 to Immacule Lifesciences
21 Nov 2025 //
FDA
FDA Approves AKEEGA For BRCA2-Mutated Prostate Cancer
13 Dec 2025 //
PR NEWSWIRE
Indoco Remedies Receives USFDA EIR For Patalganga API Facility
13 Dec 2025 //
EXPRESSPHARMA
Himachal Drug Cos Under Stop Orders Found Operational
13 Dec 2025 //
ECONOMICTIMES
Emergent Biosolutions Gets FDA Nod For Raxibacumab Production
13 Dec 2025 //
GLOBENEWSWIRE
Dominari Holdings Adjusts Record And Payment Dates For $10M Cash
13 Dec 2025 //
PR NEWSWIRE BIO
Delhi HC Denies Stay On Dr. Reddy's Export Of Semaglutide
13 Dec 2025 //
ECONOMICTIMES
Arcus Updates Phase 3 STAR-221 Study, Focuses R&D On Casdatifan
13 Dec 2025 //
PHARMIWEB
Zealand Pharma, OTR Therapeutics Ink Metabolic Collaboration
13 Dec 2025 //
GLOBENEWSWIRE
Lilly's obesity triple threat tops phase 3 efficacy forecasts
13 Dec 2025 //
PR NEWSWIRE
Lindus & Quotient Accelerate Drug Dev from FIH to Pivotal Trials
13 Dec 2025 //
PRESS RELEASE
Shilpa Pharma Gets EU Approval For Rotigotine Transdermal Patch
12 Dec 2025 //
INDPHARMAPOST
Senores Pharma Introduces Deferiprone Tablets USP In US
12 Dec 2025 //
EXPRESSPHARMA
Glenmark Pharma USA To Launch Leucovorin Calcium Injection
12 Dec 2025 //
INDPHARMAPOST
Glenmark To Launch Generic Medication In US
11 Dec 2025 //
ECONOMICTIMES
Civica To Supply Generic Medicines under Contract Awarded
11 Dec 2025 //
PR NEWSWIRE
FDA Approves Alembic's Loteprednol-Tobramycin Eye Drops
11 Dec 2025 //
EXPRESSPHARMA
Indian drugmaker Zee Laboratories promises cheap alternatives
10 Dec 2025 //
ECONOMICTIMES
Teva Moves To Delist 200-Plus Patents From FDA Registry: FTC
10 Dec 2025 //
FIERCE PHARMA
Teva Submits FDA Application For Olanzapine Injectable
09 Dec 2025 //
GLOBENEWSWIRE
Caplin Steriles Secures FDA Approval For Acetaminophen Injection
09 Dec 2025 //
INDPHARMAPOST
FDA Approves AKEEGA For BRCA2-Mutated Prostate Cancer
13 Dec 2025 //
PR NEWSWIRE
Emergent Biosolutions Gets FDA Nod For Raxibacumab Production
13 Dec 2025 //
GLOBENEWSWIRE
Arcus Updates Phase 3 STAR-221 Study, Focuses R&D On Casdatifan
13 Dec 2025 //
PHARMIWEB
Zealand Pharma, OTR Therapeutics Ink Metabolic Collaboration
13 Dec 2025 //
GLOBENEWSWIRE
Lilly's obesity triple threat tops phase 3 efficacy forecasts
13 Dec 2025 //
PR NEWSWIRE
Lindus & Quotient Accelerate Drug Dev from FIH to Pivotal Trials
13 Dec 2025 //
PRESS RELEASE
Zelluna Finishes Initial GMP Batch Of ZI-MA4-1, TCR-NK Cell Trial
12 Dec 2025 //
GLOBENEWSWIRE
Lilly's Inluriyo Shows Reinforced Efficacy in Breast Cancer
12 Dec 2025 //
PR NEWSWIRE
Tiziana Life Sciences Initiates Phase 2 Alzheimer's Trial Dosing
12 Dec 2025 //
GLOBENEWSWIRE
Tenaya Therapeutics Announces Pricing Of Public Offering
12 Dec 2025 //
GLOBENEWSWIRE
Indoco Remedies Receives USFDA EIR For Patalganga API Facility
13 Dec 2025 //
EXPRESSPHARMA
Particology Joins £8.2M Project To Revolutionize API
11 Dec 2025 //
PHARMIWEB
Lilly Selects Alabama Site as Location for $6 B API Facility
09 Dec 2025 //
FIERCE PHARMA
Is biopharma facing a microbial manufacturing crunch?
08 Dec 2025 //
FIERCE BIOTECH
DCC Backs Separate Licensing for Bulk Drugs and Excipients
05 Dec 2025 //
PHARMABIZ
Pharma Gains from Rupee's Fall Despite Reliance on APIs
04 Dec 2025 //
BUSINESS STD
Promoting Indigenous Pharma Manufacturing
04 Dec 2025 //
INDPHARMAPOST
Mangalam Drugs Receives Rs. 15 Crore Repeat Export Order
01 Dec 2025 //
INDPHARMAPOST
DoP Seeks Applications For PLI Scheme To Produce 2 Bulk Drugs
01 Dec 2025 //
PHARMABIZ
Moehs visits the UPF
28 Nov 2025 //
PRESS RELEASE
Himachal Drug Cos Under Stop Orders Found Operational
13 Dec 2025 //
ECONOMICTIMES
GAO Finds FDA Staffing Shortfalls Delaying Device Recall Work
12 Dec 2025 //
FIERCE BIOTECH
AICDF Seeks Pharma Prosecution for Decade-Long Non-Compliance
11 Dec 2025 //
PHARMABIZ
FDA Warns Companies For CGMP Violations, Unapproved Marketing
10 Dec 2025 //
RAPS
Merck, Sanofi, AZ Shots For RSV Now Under Scrutiny By FDA
09 Dec 2025 //
FIERCE PHARMA
India Pharma Inc Shifts From Compliance To Commitment In Safety
09 Dec 2025 //
EXPRESSPHARMA
FDA Panel Votes Against J&J Shunt Implant For Heart Failure
05 Dec 2025 //
FIERCE BIOTECH
USFDA Issues Form 483 With 3 Observations To Ipca's Tarapur Plant
05 Dec 2025 //
ECONOMICTIMES
Precipio Identifies Unauthorized Access to Isolated Storage
04 Dec 2025 //
GLOBENEWSWIRE
FDA Official: CDER Warning Letters Up 50% In FY 2025
04 Dec 2025 //
RAPS
Sanyou Bio & Kanrybio Partner To Co-Develop Biomarker Assay Kits
12 Dec 2025 //
PR NEWSWIRE BIO
Poppins Introduces Pediatric Care Platform For Working Parents
12 Dec 2025 //
GLOBENEWSWIRE
Peijia Medical Gets NMPA Approval For Taurustrio Valve System
12 Dec 2025 //
PR NEWSWIRE BIO
Impulse Dynamics Clinches $158M For Heart Failure Implant
12 Dec 2025 //
FIERCE BIOTECH
Harold Introduces Telehealth Platform For Men's Health Well-being
12 Dec 2025 //
GLOBENEWSWIRE
Anova Launches Free AI-enabled Clinical Trial Patient
12 Dec 2025 //
BUSINESSWIRE
Nhs Confederation Responds to Government Offer to Resident Doctor
11 Dec 2025 //
PHARMIWEB
Medra Raises $52 Million Series A To Build Physical AI Scientists
11 Dec 2025 //
BUSINESSWIRE
Main Line Health Research Leader Receives Top Inventor Honor
11 Dec 2025 //
PR NEWSWIRE
Heartflow FFRCT Analysis Boosts Prognostic Power And Cuts Costs
11 Dec 2025 //
GLOBENEWSWIRE
Sobi Gets CHMP Nod For Aspaveli In C3G And Primary IC-MPGN
12 Dec 2025 //
PR NEWSWIRE BIO
Orphalan Announces Acquisition Of Orphelia Pharma
12 Dec 2025 //
PR NEWSWIRE
Biocryst Launches ORLADEYO Oral Pellets For Pediatric HAE
12 Dec 2025 //
GLOBENEWSWIRE
Acadia Pharma Gets FDA Nod For DAYBUE STIX In Rett Syndrome
12 Dec 2025 //
BUSINESSWIRE
Rezolute Stock Sinks 87% As Hypoglycemia Drug Fails Ph. 3 Test
12 Dec 2025 //
FIERCE BIOTECH
Sanofi's Qfitlia and Cablivi approved in China
12 Dec 2025 //
PRESS RELEASE
Xinnate Gets FDA Nod For TCP-25, Advancing Epidermolysis Bullosa
11 Dec 2025 //
PHARMIWEB
Savara To Secure EPO Patent For MOLBREEVI Liquid Formulation
11 Dec 2025 //
BUSINESSWIRE
Rhythm Pharma's Setmelanotide Effective in Prader-Willi Syndrome
11 Dec 2025 //
GLOBENEWSWIRE
Ophirex Nears FDA Approval for Varespladib Snakebite Drug
11 Dec 2025 //
GLOBENEWSWIRE
Dominari Holdings Adjusts Record And Payment Dates For $10M Cash
13 Dec 2025 //
PR NEWSWIRE BIO
Delhi HC Denies Stay On Dr. Reddy's Export Of Semaglutide
13 Dec 2025 //
ECONOMICTIMES
Zevra Therapeutics Announces Inducement Grants Under Nasdaq LR
12 Dec 2025 //
GLOBENEWSWIRE
ZCG-Backed Unimed Acquires Elssi Maritime Services
12 Dec 2025 //
PHARMIWEB
West To Participate In Upcoming Investor Conference
12 Dec 2025 //
PR NEWSWIRE
Vsee Health Regains Nasdaq Stockholders' Equity Compliance
12 Dec 2025 //
PHARMIWEB
Vsee Health Postpones Annual Stockholders Meeting To December
12 Dec 2025 //
PHARMIWEB
Finance Ministry Allows 15 Firms To Import Morphine, Codeine
12 Dec 2025 //
PHARMABIZ
FDA Approves Nuzolvence for Uncomplicated Urogenital Gonorrhea
12 Dec 2025 //
BUSINESSWIRE
Tharimmune Appoints Jacob Asbury CFO For Canton Coin Treasury
12 Dec 2025 //
BUSINESSWIRE

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