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
Building Confidence Beyond Compliance With Media Fills Designed for the Annex 1 Era

In the Annex 1 era, media fills must replicate the routine aseptic manufacturing process as closely as possible. This includes all critical manufacturing s...

August 03, 2026 | Monday | Expert Opinion
NeuroPace to Work with FDA After PMA Supplement for IGE Indication Receives Non-Approvable Letter

-- Company received communication from FDA indicating that the PMA Supplement for idiopathic generalized epilepsy is not approvable in its current form...

July 30, 2026 | Thursday | News
Takeda Reported Phase 3 Zasocitinib Data Showing Strong Skin Clearance in Plaque Psoriasis

Takeda (TSE:4502/NYSE:TAK) announced new data from the two pivotal Phase 3 studies of zasocitinib (TAK-279), a next-generation, highly selective and pote...

July 30, 2026 | Thursday | News
Arrowhead Completed Enrollment in Phase 3 YOSEMITE Trial of Zodasiran for HoFH

-Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has completed enrollment in the global Phase 3 YOSEMITE clinical trial of zodasir...

July 29, 2026 | Wednesday | News
Sanofi Discontinues Development of Amlitelimab for Atopic Dermatitis

Sanofi announced the discontinuation of clinical development of amlitelimab, an OX40-ligand monoclonal antibody, in moderate-to-severe atopic dermatitis ...

July 28, 2026 | Tuesday | News

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