Aurisco Pharmaceutical Passes USFDA Inspection as First Generic Oligonucleotide API Manufacturer

Aurisco Pharmaceutical, a leading global Oligonucleotide and Peptide (TIDES) manufacturer, announced that its site in Yangzhou, China has passed the USFDA ...

August 17, 2026 | Monday | News
Veloxis Pharmaceuticals to Pay $46 Million to Resolve Envarsus XR Fraud Case

In a major healthcare fraud enforcement action, Veloxis Pharmaceuticals will pay over million and accept a stringent deferred prosecution agreement ...

August 17, 2026 | Monday | News
Summit Therapeutics’ Ivonescimab Regimen Gains Third NMPA Approval in China

Marks Third NMPA Approval in China for an Ivonescimab-Containing Regimen NMPA Approval Based on HARMONi-6 Clinical Trial Conducted by Akeso in China ...

August 14, 2026 | Friday | News
Japan Becomes First Market Where Joenja Is Commercially Available for Children Aged 4 to 11

Launch marks first commercial availability of Joenja® (leniolisib) for children aged 4 to 11 worldwide OrphanPacific, Inc. serves as Marketing Au...

August 14, 2026 | Friday | News
Belite Bio Wins FDA Priority Review for Tinlarebant in Stargardt Disease

Prescription Drug User Fee Act target action date is February 12, 2027 If approved, tinlarebant would be the first-ever approved treatment for Stargar...

August 13, 2026 | Thursday | News
Lupin Receives U.S. FDA Approval for Generic Lokelma in Hyperkalemia

Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN)  announced that it has rec...

August 12, 2026 | Wednesday | News
QIAGEN Wins FDA Clearance for QIAstat-Dx Bloodstream Infection Panel

QIAstat-Dx BCID GPF Plus AMR Panel detects 20 pathogen targets and 10 antimicrobial resistance markers from positive blood cultures in about one hour...

August 12, 2026 | Wednesday | News
Fresenius Kabi Recalls Tyenne Injection Lot Over Glass Particle Contamination

Fresenius Kabi, an operating company of the Fresenius Group, is recalling one lot of Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 m...

August 12, 2026 | Wednesday | News
Alebund Pharmaceuticals’ AP301 NDA Accepted for Review by China’s NMPA

Alebund Pharmaceuticals (Jiangsu) Limited ("Alebund" or the "Company"; HKEX: 09637), a renal-focused biopharmaceutical company, announced that the New Dr...

August 11, 2026 | Tuesday | News
Innate Pharma Partners with Sobi to Advance Lacutamab in Cutaneous T-Cell Lymphoma

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") and Swedish Orphan Biovitrum AB (publ) (Sobi®) announced that they h...

August 11, 2026 | Tuesday | News
Takeda Receives FDA Approval for ORZEYFUL to Treat Adults with Narcolepsy Type 1

Adults Taking ORZEYFUL Experienced Significant and Meaningful Improvements Across the Full Range of Symptoms of Narcolepsy Type 1 (NT1) in Clinical T...

August 07, 2026 | Friday | News
Leads Biolabs Advances Phase II Study of Opamtistomig Combination Therapy for First-Line Liver Cancer

Nanjing Leads Biolabs Co., Ltd. announced that its Phase II clinical study evaluating Opamtistomig (LBL-024), a proprietary PD-L1/4-1BB bispecific antibo...

August 07, 2026 | Friday | News
Sanofi’s MenQuadfi Gains EU Approval for Infants From Six Weeks of Age

Sanofi’s MenQuadfi approved in the EU for use in infants from age six weeks against invasive meningococcal disease Sanofi announced that the Europ...

August 05, 2026 | Wednesday | News
Novartis Secures FDA Approval for Pluvicto in Earlier-Stage Metastatic Prostate Cancer

Pluvicto now approved across PSMA+ metastatic prostate cancer, nearly doubling eligible patient population PSMAddition updated results show Pluvicto r...

August 04, 2026 | Tuesday | News

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