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Lupin receives EIR from USFDA for Nagpur injectable facility
Drug Approval | December 17, 2025

Lupin receives EIR from USFDA for Nagpur injectable facility

The EIR was issued following an inspection of the facility from September 8 to September 16, 2025


AstraZeneca wins EU nod for self-administered lupus drug Saphnelo
News | December 17, 2025

AstraZeneca wins EU nod for self-administered lupus drug Saphnelo

Convenient subcutaneous option has potential to reach more patients with same clinical benefits as Saphnelo IV infusion


Cynata completes patient enrollment for Phase 2 aGvHD clinical trial
Clinical Trials | December 17, 2025

Cynata completes patient enrollment for Phase 2 aGvHD clinical trial

Patient enrolment has been completed in Cynata's Phase 2 clinical trial of CYP-001 in acute graft versus host disease


Merck KGaA launches ChemiSphere App to digitize lab workflows
Digitisation | December 17, 2025

Merck KGaA launches ChemiSphere App to digitize lab workflows

The ChemiSphere app exemplifies how M-Trust technology transforms workflows into seamless digital experiences


Pfizer cuts 2026 revenue outlook amid COVID-19 & patent losses
News | December 17, 2025

Pfizer cuts 2026 revenue outlook amid COVID-19 & patent losses

The pharmaceutical giant now expects 2026 revenues to land between $59.5 billion and $62.5 billion


Minghui Pharmaceutical gets FDA green light for Phase III trials of its therapy in thyroid eye disease
Clinical Trials | December 17, 2025

Minghui Pharmaceutical gets FDA green light for Phase III trials of its therapy in thyroid eye disease

The upcoming trials will evaluate both active and chronic TED in randomized, double-blind, placebo-controlled studies


Ascletis Pharma reports positive Phase I results for oral IL-17 inhibitor
Clinical Trials | December 17, 2025

Ascletis Pharma reports positive Phase I results for oral IL-17 inhibitor

The randomized, double-blind, placebo-controlled single ascending dose (SAD) study evaluated safety, tolerability, pharmacokinetics, and target engagement in 46 healthy participants


Vanda Pharmaceuticals seeks FDA nod for breakthrough psoriasis drug
Drug Approval | December 17, 2025

Vanda Pharmaceuticals seeks FDA nod for breakthrough psoriasis drug

Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients


FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission
Biopharma | December 16, 2025

FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease


Ind-Swift Laboratories receives GMP compliance certificate from NNGYK-Hungary
News | December 16, 2025

Ind-Swift Laboratories receives GMP compliance certificate from NNGYK-Hungary

The said certificate is valid for a period of 3 years and opens up the European and other markets for the company's products