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The accelerated approval marks the first indication beyond lung cancer for J&J’s bispecific antibody.

Pharma Tech
Through its PPIE initiative, the MHRA plans to consider a diverse range of patient and public opinions when making regulatory decisions.

Pharma Tech
Armada Acquisition has entered a definitive business combination agreement with Brains Bioceutical that values the latter at an implied pre-money equity value of $750m.

Pharma Tech
Alfasigma has received the EC's expanded approval for Jyseleca to treat adult patients living with active axial spondyloarthritis (axSpA).

Pharma Tech
Cordavis was established by CVS Health three years ago to capture more of the US biosimilar supply chain.
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ET Pharma
Nov 7, 2026, 2:05 AM
GSK had sued Moderna in 2024 over lipid nanoparticle technology used in the vaccines to transport fragile messenger RNA (mRNA) into the human body
ET Pharma
Nov 7, 2026, 2:03 AM
The company intends to perform the groundbreaking ceremony for the project before the Global Investors' Meet scheduled for April next year and is keen to commence manufacturing activities, Large and Medium Industries Minister M B Patil said.
Pharma Tech
Nov 6, 2026, 11:34 AM
The accelerated approval marks the first indication beyond lung cancer for J&J’s bispecific antibody.
PharmaShots
Nov 6, 2026, 11:08 AM
Shots: ANI Pharmaceuticals has announced a recommended public cash offer to acquire Egetis Therapeutics for SEK 11.25/share (27% premium to the 60-day VWAP), valuing the offer at ~SEK 5.6B (~$560M); EV ~$434M after adjusting for Egetis’ $190M Rare Pediatric Disease PRV sale Deal adds Emcitate (tiratricol), the first & only approved therapy in the US… The post ANI Pharmaceuticals Announces ~$560M Recommended Cash Offer to Acquire Egetis Therapeutics appeared first on PharmaShots.
PharmaShots
Nov 6, 2026, 11:07 AM
Shots: The US FDA has assigned a PDUFA target action date of Apr 9, 2027, for Elevar Therapeutics’ resubmitted NDA of rivoceranib + Hengrui Pharma’s resubmitted BLA of camrelizumab as 1L systemic therapy for unresectable or metastatic HCC Applications will be reviewed under an integrated process; the Oct 9, 2026, resubmissions respond to the FDA’s… The post The US FDA Sets PDUFA Date of Apr 9, 2027 for Elevar’s Resubmitted Rivoceranib + Camrelizumab NDA in 1L uHCC appeared first on PharmaShots.
PharmaShots
Nov 6, 2026, 11:05 AM
Shots: The US FDA has granted De Novo marketing authorization (Nov 4, 2026) to Theraclion’s Sonovein for coagulation of blood vessels in pts with superficial venous reflux in Great Saphenous Vein (GSV) segments, establishing a new device classification Authorization was supported by the Pivotal (VEINRESET) study (n=70; 4 US & EU centers; NCT05926830), which met… The post Theraclion’s Sonovein Receives the US FDA’s De Novo Authorization for Non-Invasive Treatment of GSV Reflux appeared first on PharmaShots.
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