Latest Pharma and Biotech News
Biotechnology
8 May 2026 Avalo Therapeutics’ shares surged 34%, after the US clinical-stage biotech announced positive top-line results from its Phase II LOTUS trial evaluating the efficacy and safety of abdakibart in adults with moderate to severe hidradenitis suppurativa (HS).
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Pharmaceutical
Drug regulators across major markets put safety, supply and post-market oversight at the centre of activity over the past week, with a US cancer-drug approval providing the main product-review headline while agencies in Europe, Brazil, Singapore, France and Ireland moved on recalls, shortages, enforcement and risk communication. 11 May 2026
Pharmaceutical
Among important regulatory news last week, the US Food and Drug Administration (FDA) approved Axsome Therapeutics’ Alzheimer’s agitation candidate Auvelity, and an FDA Advisory Committee voted against approval of AstraZeneca’s breast cancer drug camizestrant. US biotech Madrigal Pharma revealed a deal with Arrowhead Pharma to acquire rights to its investigational MASH treatment ARO-PNPLA3. Germany’s Bayer announced its proposed acquisition of Perfuse Therapeutic, aiming to reinforce it ophthalmics drug pipeline. 10 May 2026
Biotechnology
The US Food and Drug Administration (FDA) late Friday approved a label expansion for Netherlands-based argenx’ Vyvgart efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG). 9 May 2026
Biotechnology
The US Food and Drug Administration (FDA) has approved privately-held US biotech Partner Therapeutics’ (PTx) Bizengri (zenocutuzumab-zbco), a drug for adults with a rare form of bile duct cancer as part of a new fast-track review program, the agency said on Friday. 9 May 2026
Pharmaceutical
An interview with Francesco Di Marco, the new chief executive of Italfarmaco. 8 May 2026
Generics
Russia is experiencing a boom of sales of obesity drugs, which is mainly due to the recent launch of some domestically developed drugs in this market segment, reports The Pharma Letter’s local correspondent. 8 May 2026
Pharmaceutical
US pharma major Bristol Myers Squibb today announced that the European Commission has granted approval to Sotyktu (deucravacitinib), alone or in combination with methotrexate, for the treatment of active psoriatic arthritis (PsA). 8 May 2026
Biotechnology
US biotech major Gilead Sciences has reported first-quarter 2026 results ahead of Wall Street expectations, driven by continued strength in its HIV franchise. 8 May 2026
Pharmaceutical
BrightGene Bio-Medical says its dual GLP-1/GIP agonist BGM0504 met all primary and key secondary endpoints in a Phase III obesity study, as competition sharpens in the booming weight-loss market. 8 May 2026
Pharmaceutical
US biotech startup ParcelBio has emerged from stealth with a $13 million seed financing aimed at overcoming one of the key biological constraints limiting broader use of mRNA medicines beyond vaccines and short-acting therapies. 8 May 2026
Biotechnology
North Carolina, USA-based clinical-stage gene therapy company Atsena Therapeutics has presented data from three studies at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Denver. 8 May 2026
Biotechnology
Privately-held French drugmaker Pierre Fabre Pharmaceuticals says it has reached agreement with the US Food and Drug Administration (FDA) on a potential path forward for resubmitting the Biologics License Application (BLA) for tabelecleucel, following a recent Type A meeting with the agency. 8 May 2026
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has recommended approval for US healthcare giant Johnson & Johnson’s Rybrevant (amivantamab). 8 May 2026
Pharmaceutical
New US tariff measures and acute geopolitical tensions are reshaping the global pharmaceutical landscape, prompting companies to rethink supply chains and production strategies, says intelligence and productivity platform. GlobalData. 8 May 2026
Pharmaceutical
British pharma major AstraZeneca is expanding its oncology-focused artificial intelligence collaboration with US biotech Immunai in a deal that could bring the smaller company up to $37.5 million over 2026-2027. 8 May 2026
Biotechnology
Avalo Therapeutics’ shares surged 34%, after the US clinical-stage biotech announced positive top-line results from its Phase II LOTUS trial evaluating the efficacy and safety of abdakibart in adults with moderate to severe hidradenitis suppurativa (HS). 8 May 2026
Biotechnology
Canadian genetic medicines company enGene Therapeutics reported additional interim results from the pivotal cohort of its ongoing, Phase II LEGEND trial of detalimogene voraplasmid (also known as detalimogene) in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ (CIS) with or without concomitant papillary disease, which enrolled 125 patients. 8 May 2026
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Japanese drugmaker Otsuka’s Dawnzera (donidalorsen) to prevent angioedema attacks. 7 May 2026
Pharmaceutical
Shares of Catalyst Pharmaceuticals are trading at around $30.52 to $31.50, following an announcement that Italy’s Angelini Pharma will acquire the company for $31.50 per share in cash. 7 May 2026
Biotechnology
Swiss contract development and manufacturing organization (CDMO) Lonza and US pharma major Bristol Myers Squibb (NYSE: BMY) today announced an exclusive single-target licensing agreement. 7 May 2026
All news
Pharmaceutical
Drug regulators across major markets put safety, supply and post-market oversight at the centre of activity over the past week, with a US cancer-drug approval providing the main product-review headline while agencies in Europe, Brazil, Singapore, France and Ireland moved on recalls, shortages, enforcement and risk communication. 11 May 2026
Pharmaceutical
Among important regulatory news last week, the US Food and Drug Administration (FDA) approved Axsome Therapeutics’ Alzheimer’s agitation candidate Auvelity, and an FDA Advisory Committee voted against approval of AstraZeneca’s breast cancer drug camizestrant. US biotech Madrigal Pharma revealed a deal with Arrowhead Pharma to acquire rights to its investigational MASH treatment ARO-PNPLA3. Germany’s Bayer announced its proposed acquisition of Perfuse Therapeutic, aiming to reinforce it ophthalmics drug pipeline. 10 May 2026
Biotechnology
The US Food and Drug Administration (FDA) late Friday approved a label expansion for Netherlands-based argenx’ Vyvgart efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG). 9 May 2026
Biotechnology
The US Food and Drug Administration (FDA) has approved privately-held US biotech Partner Therapeutics’ (PTx) Bizengri (zenocutuzumab-zbco), a drug for adults with a rare form of bile duct cancer as part of a new fast-track review program, the agency said on Friday. 9 May 2026
Pharmaceutical
An interview with Francesco Di Marco, the new chief executive of Italfarmaco. 8 May 2026
Generics
Russia is experiencing a boom of sales of obesity drugs, which is mainly due to the recent launch of some domestically developed drugs in this market segment, reports The Pharma Letter’s local correspondent. 8 May 2026
Pharmaceutical
US pharma major Bristol Myers Squibb today announced that the European Commission has granted approval to Sotyktu (deucravacitinib), alone or in combination with methotrexate, for the treatment of active psoriatic arthritis (PsA). 8 May 2026
Biotechnology
US biotech major Gilead Sciences has reported first-quarter 2026 results ahead of Wall Street expectations, driven by continued strength in its HIV franchise. 8 May 2026
Pharmaceutical
BrightGene Bio-Medical says its dual GLP-1/GIP agonist BGM0504 met all primary and key secondary endpoints in a Phase III obesity study, as competition sharpens in the booming weight-loss market. 8 May 2026
Pharmaceutical
US biotech startup ParcelBio has emerged from stealth with a $13 million seed financing aimed at overcoming one of the key biological constraints limiting broader use of mRNA medicines beyond vaccines and short-acting therapies. 8 May 2026
Biotechnology
North Carolina, USA-based clinical-stage gene therapy company Atsena Therapeutics has presented data from three studies at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Denver. 8 May 2026
Biotechnology
Privately-held French drugmaker Pierre Fabre Pharmaceuticals says it has reached agreement with the US Food and Drug Administration (FDA) on a potential path forward for resubmitting the Biologics License Application (BLA) for tabelecleucel, following a recent Type A meeting with the agency. 8 May 2026
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has recommended approval for US healthcare giant Johnson & Johnson’s Rybrevant (amivantamab). 8 May 2026
Pharmaceutical
New US tariff measures and acute geopolitical tensions are reshaping the global pharmaceutical landscape, prompting companies to rethink supply chains and production strategies, says intelligence and productivity platform. GlobalData. 8 May 2026
Pharmaceutical
British pharma major AstraZeneca is expanding its oncology-focused artificial intelligence collaboration with US biotech Immunai in a deal that could bring the smaller company up to $37.5 million over 2026-2027. 8 May 2026
Biotechnology
Avalo Therapeutics’ shares surged 34%, after the US clinical-stage biotech announced positive top-line results from its Phase II LOTUS trial evaluating the efficacy and safety of abdakibart in adults with moderate to severe hidradenitis suppurativa (HS). 8 May 2026
Biotechnology
Canadian genetic medicines company enGene Therapeutics reported additional interim results from the pivotal cohort of its ongoing, Phase II LEGEND trial of detalimogene voraplasmid (also known as detalimogene) in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ (CIS) with or without concomitant papillary disease, which enrolled 125 patients. 8 May 2026
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Japanese drugmaker Otsuka’s Dawnzera (donidalorsen) to prevent angioedema attacks. 7 May 2026
Pharmaceutical
Shares of Catalyst Pharmaceuticals are trading at around $30.52 to $31.50, following an announcement that Italy’s Angelini Pharma will acquire the company for $31.50 per share in cash. 7 May 2026
Biotechnology
Swiss contract development and manufacturing organization (CDMO) Lonza and US pharma major Bristol Myers Squibb (NYSE: BMY) today announced an exclusive single-target licensing agreement. 7 May 2026
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